WO2015183226A2 - Unilateral bone fixator system enabling bone extension and three dimensional fixation - Google Patents

Unilateral bone fixator system enabling bone extension and three dimensional fixation Download PDF

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Publication number
WO2015183226A2
WO2015183226A2 PCT/TR2015/000233 TR2015000233W WO2015183226A2 WO 2015183226 A2 WO2015183226 A2 WO 2015183226A2 TR 2015000233 W TR2015000233 W TR 2015000233W WO 2015183226 A2 WO2015183226 A2 WO 2015183226A2
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WO
WIPO (PCT)
Prior art keywords
bone
joint
clamp
screw
sphere
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Application number
PCT/TR2015/000233
Other languages
French (fr)
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WO2015183226A3 (en
Inventor
Hacı KUTLU
Original Assignee
Spi̇namer Sağlik Ürünleri̇ Sanayi̇ Ve Teknoloji̇ Li̇mi̇ted Şi̇rketi̇
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Publication of WO2015183226A2 publication Critical patent/WO2015183226A2/en
Publication of WO2015183226A3 publication Critical patent/WO2015183226A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66Alignment, compression or distraction mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6416Devices extending alongside the bones to be positioned with non-continuous, e.g. hinged, pin-clamp connecting element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6466Devices extending alongside the bones to be positioned with pin-clamps movable along a solid connecting rod

Definitions

  • External fixator is the device which locates bone fragments by means of nails or wires in a stable way until union is completed. Even though studies on this subject started in the midst of XIX. Century, the first critical external fixator example was given by Lambotte in 1902.
  • the objective of the invention is to reduce above mentioned patient-related complications by practical and secure surgical method and practical extension, during treatment, inspiring from the existing situations.
  • Figure 8 is the exploded and perspective view of the binary ball socket joint in the alternative configuration of the fixator configuration according to the invention.
  • the unilateral bone fixator is a unilateral-monoaxial fixator system that offers original solutions such as practical and secure surgical technique and patient adaptation. Moreover, the system has intrinsic mechanical complementary modules. According to the invention the unilateral fixator system is generally composed of the following:
  • Sliding Clamp (2) It is the clamp that located the shaft of the long bones with the bone screw channels (2.4) and conical fixing screw (2.2) system placed on the same axis. The clamp moves by sliding on the extension module; by means of the sliding channel (2.3) located at 90 degrees to the screw channels (2.4). Sliding clamp is fixed to the sequential channels (3.2) on the extension module (3) by two eccentric screws (2.1) that are 90 degrees to sliding channel (2.3).

Abstract

The present invention relates to a unilateral monoaxial external bone fixator, which provides practical and secure usage for the surgeon and the patient, reduces patient-related complications; makes extension-shortening by the roller extension unit (3), locates the bone unilaterally in a practical and secure way by means of original bone clamps (1,2,5); can make fixation by means of the original joints (4,7) and fixation module (8).

Description

Unilateral Bone Fixator System Enabling Bone Extension And Three Dimensional Fixation Field of the Invention
The invention relates to devices named external fixator, which unilaterally fixes bone fragments via bone screws until bone union is completed in a stable way.
The invention particularly relates to a practical and secure unilateral fixator system which enables to reduce complications during treatment.
Background of the Invention
External fixator is the device which locates bone fragments by means of nails or wires in a stable way until union is completed. Even though studies on this subject started in the midst of XIX. Century, the first critical external fixator example was given by Lambotte in 1902.
The first fixator advanced versions of which is being used in the present day is the fixator developed by Hoffman in 1938. This configuration is followed by Wagner's unilateral fixator.
Following these developments, successful results of ilizarov external fixator, which is the circular type fixator, carried the use of this method and devices to all world clinics.
By De Bastiani et al.'s introduction of the dynamic axial fixator, which is a unilateral monoaxial fixator, to the world in 1979, monoaxial fixators started to be used commonly in the worid and these configurations were followed by various enhancements. US5320623, US5342360, US5437667, EP0695538B, EP0775468A1 , EP0955928B1 , EP1486174A2, US5601551 , US8388619 can be shown as examples of these enhancements. In 1997, Dr. Haci Kutlu introduced the modular dynamic axial fixator system, which he named Holyfix. In 2002 and 2003, the system was enhanced and became applicable in the global scale.
Circular fixators are also used for the purpose of bone extension and fixation, and in the last ten years, computer aided manual and motorized circular fixators have been defined. Applications numbered US 2002/0010465, EP1239784B1 , EP2085037A1 , EP2085038B1 , EP2417924A1 can be shown as examples. Unilateral and monoaxial fixators are systems that are very different from circular fixators; they are less invasive than circular fixators and they have less risk of vein and nerve injuries. They are also the systems that are accepted more by the patients. In existing monoaxial extension fixators, similarly important problems confronted while practical and secure solutions cannot be provided all the time. The fact that manual fixators cannot be used by patients and their relatives as they want and the complications arising from this are the complications that can be controlled by design and technological novelties. As a result, due to the abovementioned negative aspects and the inefficiency of the existing solutions about the subject, enhancement or improvement studies should be done in the related field for developing a new practical unilateral fixator, which shortens operation time, in order to reduce patient-related complications, differently from the known methods. Objective of the Invention
The objective of the invention is to reduce above mentioned patient-related complications by practical and secure surgical method and practical extension, during treatment, inspiring from the existing situations.
Another objective of the invention is to enable a simple and secure extension and fixation operation.
Still another objective of the invention is to enable sensitive extension operations.
A further objective of the invention is to enable a configuration which is compatible with MRI (Magnetic Resonance Imaging).
Structural and characteristic features and the advantages of the invention will be comprehended more clearly with the accompanying figures and the detailed description written by references to these figures; and thus assessments should be done considering these figures and the detailed description.
Figures to Assist Understanding the invention
Figure 1 is the perspective view of the unilateral monoaxial fixator articulated model according to the invention. Figure 2 is the perspective view of the unilateral monoaxial fixator inarticulate model according to the invention.
Figure 3 is the perspective view of the unilateral monoaxial fixator binary articulated model according to the invention.
Figure 4, 4a are the view of metaphysis clamp in the fixator configuration according to the invention.
Figure 5 is the view of the sliding clamp in the fixator configuration, with the eccentric screws according to the invention.
Figure 6 is a view of the fixation module in the fixator configuration according to the invention. Figure 7 is the demounted view of the smart ball socket joint in the fixator configuration according to the invention.
Figure 8 is the exploded and perspective view of the binary ball socket joint in the alternative configuration of the fixator configuration according to the invention.
Figure 9 is the perspective view of the extension module in the fixator configuration according to the invention.
Figure 9a is the detailed sectional view of the extension module in the fixator configuration according to the invention.
DESCRIPTION OF PIECE REFERENCES
1. Metaphysis Clamp (Figure 4, 4a) 4. Smart Joint (Figure 7)
1.1. Conical fixing screws 4.1. Sliding sphere
1.2. Screw channel 4.2.Sphere clamping apparatus
1.3. Bone screw channel 4.3. Joint socket
1.4. Adaptor fixing -bolt 4.4. Reverse grooved push rod
2. Sliding Clamp (Figure 5) 4.5. Ramped conic
2.1. Eccentric screws 5. Half Sliding Clamp
2.2. Conical fixing screws 6. Articulated Metaphysis Clamp
2.3. Sliding channel 7. Binary Smart Joint (Figure 8)
2.4. Bone screw channel 7.1. Wrist sphere clamping Apparatus
3. Manual Extension Module (Figure 9, 7.2. Radiolucent connection rot
3.1. External tube 7.3. Ramped conic
3.2. Channels 7.4. Reverse grooved push rod
3.3. Screwed shaft 8. Correction module (Figure 6)
3.4. Rollers 8.1. Male adaptor
3.5. Internal tube 8.2. Joint screw
3.5.1. Joint socket 8.3. Adaptor screws
3.5.2. Reverse grooved push rod 8.4. Geared screw
3.6. Allen wrench slot 8.5. Geared joint end
8.6. Female adaptor slot
Drawings must not be scaled and details which are not necessary to understand the present invention may be neglected. Other than that, the elements that are at least identical to a great extent or at have least identical functions to a great extent are shown with the same numbers.
DETAILED DESCRIPTION OF THE INVENTION
In this detailed description, according to the invention the preferred configurations of the bone extension and three dimensional fixation fixator are explained only to enable the subject to be understood better. According to the invention the unilateral bone fixator is a unilateral-monoaxial fixator system that offers original solutions such as practical and secure surgical technique and patient adaptation. Moreover, the system has intrinsic mechanical complementary modules. According to the invention the unilateral fixator system is generally composed of the following:
Metaphysis Clamp (1): The heads of long bones which are close to the joint are called metaphysis. It is a wide area and allows bone screw application in different combinations. It has bone screw channels (1.3) located in horizontal and vertical axis. Bone screws are fixed separately by means of conical fixing screws (1.1) proper to the system. For this purpose, the bone screw is placed into the screw channel (1.3). Conical fixing screw channel (1.2) is perpendicular to the bone screw channels (1.3) and is connected with bone screw channel (1.3). The body of the bone screw (1.1) is in conical shape. Conical fixing screws (1.1) are rotated less than one tour clockwise; and thus fix the bone screws practically by conical site of the conical fixing screw (1.1) clamping the bone screw into the bone screw chanel (1.3). Metaphysis clamp (1) is located to the fixation module (8), joint (4) or extension module (3) with the adaptor slot (1b2) on the other end thereof, by means of the adaptor fixing bolt (1.4) or the eccentric screw thereon (Figure 4, 4a).
Sliding Clamp (2): It is the clamp that located the shaft of the long bones with the bone screw channels (2.4) and conical fixing screw (2.2) system placed on the same axis. The clamp moves by sliding on the extension module; by means of the sliding channel (2.3) located at 90 degrees to the screw channels (2.4). Sliding clamp is fixed to the sequential channels (3.2) on the extension module (3) by two eccentric screws (2.1) that are 90 degrees to sliding channel (2.3).
Extension Module (3): It is formed of two interpenetrating tubes. At one end of the internal tube (3.5), there is the adaptor heel that is adapted to the joint or the metaphysis clamp. On the external tube (3.1), there is a surface adapted for the sliding clamp and transversal channels (3.2) for the eccentric screws (2.1) locating the clamp. The sliding clamp moves in a modular way and is located to the channels (3.2) thereon with eccentric screws (2.1). Extension and shortening screwed shafts (3.3) are placed in the tubes. The screwed shaft (3.3) is connected to the external tube (3.1) with piston ring(s) and/or roller(s) (3.4). Tubes are developed such that they only make extension and shortening sensitively, without making rotation. With the extension key slot (3.6) at one end of the shaft (3.3), when the shaft (3.1) is rotated to a direction, the external tube (3.1) moves over the internal tube (3.2) and makes extension; and when it is rotated in the opposite direction it makes shortening (Figures 9, 9a).
Smart Joint (4): It is of the joint modules of the system and made of rigid materials such as titanium or stainless steel; and is the joint with monoblock and modular alternatives comprising sphere and socket end shaft (3.5.2) slot therein, non-circular reverse grooved binary screw channel (4.6) on both narrow sides thereof; and composed of elliptic sphere clamping apparatus (4.2) close to rectangular prism for reducing superposition in rontgenography, socket shaft (3.5.2) made of a softer material such as aluminium corresponding the sphere, reverse grooved binary screw (4.4) with alien wrench on one side, and two conical pushers (4.5) (Figure 7).
Mode of operation: The sliding sphere clamping apparatus is placed in the sphere slot, such that the slide remains outside. Socket shaft is placed in the clamping apparatus in such a way to grasp the sphere. Binary screw is placed into the binary screw channel on the socket shaft, from the conical push slots on the clamping apparatus. From both ends, the conical pushers with square rear end and conical front end are placed to the binary screw such that the conical ends remain inside. When the binary screw is rotated by the alien on the binary screw, socket shaft is pushed to the sphere and the joint is fixed; when it is rotated in opposite direction the joint is drawn away (Figure 7).
Articulated Metaphysis Ctamp (7): It is the articulated metaphysis clamp designed for more moving areas such as wrists. It is the form of the abovementioned joint embedded in the metaphysis clamp. The wrist sphere clamping apparatus (7.1) designed in compliance with the form of the clamp operates by fixing the joint sphere to the clamp by means of the binary shaft- conical push complex (7.3,7.4), (instead of socket shaft) the socket on the clamp (7.5) and the binary shaft channel (7.6). It can be directly mounted to the extension module as well as being connected by means of the joints of the system. Also, the joints of the system, as in the wrist fixator, can be connected to the sphere slides by radiolucent connection rot (7.2) (Figure 8).
3D correction module (8): It has an male adaptor (8.1) for metaphysis clamp (1) on one end and an adaptor (8.6) for extension module on the other end. The edge of the male adaptor (9) is in an inwardly decreasing conical shape and with collar. On the continuation of the collar, there is a circular section having a scale thereon. Continuation thereof there is the male part of the joint. It is a single-planned joint fixed in the desired angle by the joint screw (8.2). The female part of the joint has a redactor mechanism (8.4) which is placed on the body thereof and can move the joint by working with the male part of the joint in a rotating manner (Figure 6).
For correction, the (eccentric) screws (8.3) on the adaptors are loosened and the fixation module can be rotated around its axis in 360 degrees. The position of the joint is adjusted according to the angle to make the fixation and brought to the peak point of the bone curvature. Adaptor screws (8.3) are tightened and the correction module is iocked. By loosening the joint screw (8.2), the reducer system is rotated, thus correction is done and the joint is fixed. The system can perform its function following the operation steps below:
• Bone is fixed by the help of bone screw by using screw channels (1.3, 2.4) at the clamps (1,2,5). Other bone screws are alternately applied in the proper configuration and number and the screws are located to the clamp.
Afterwards, if extension is required, bone osteotomy is performed.
if needed, correction and fixation is performed by using the joint (4,6,7).
If only extension is desired, extension or shortening is started preferably one week after the operation.
The procedure is followed by periodic controls.

Claims

1. Monoaxiai unilateral external bone fixator, which fixes the bone tissue by bone screw and clamps; can make fixation by means of joints and fixing units; can make extension or shortening by means of extension units, in the field of orthopaedics and traumatology; characterized in comprising
metaphysis clamp (1),
sliding clamp (2),
joint,
correction module (8),
- roller manual extension module (3).
2. Bone fixator according to Claim 1 , characterized in that said joint is smart joint (4).
3. Bone fixator according to Claim 1 , characterized in that said joint is binary smart joint (7).
4. Bone fixator according to Claim 1 , characterized in that the manual extension module (3) comprises
two telescopic tubes that don't undergo a rotation while working in one another;
- channels (3.2) located on the external tube (3.1) in a parallel position and used for locating the sliding clamp (2) and half sliding clamp (5) by the eccentric screw (2.1);
at least one screwed shaft (3.3) which moves the external tube (3.1) on the internal tube (3.5);
- piston ring roller(s) (3.4) connecting the screwed shaft (3.3) to the external tube (3.1);
key slot (3.6) at the outward end of the screwed shaft;
external end of the internal tube (3.5) having differences for joint and clamp adaptations.
5. Bone fixator according to Claim 1, characterized in that said modular metaphysis clamp (1) comprises
bone screw channels (1.3) ,which enable to fix metaphysis areas of long bones, are located in horizontal and vertical axis;
- conical fixing screw channel (1.2) which is under connection and located perpendicular to the bone screw channel (1.3); conical fixing screws (1.1) which fix the bone screws by clamping it to the nail channel by the conical body when rotated clockwise;
adaptor slot (1b.2) at the other end of the clamp, enabling to couple correction module{5), joint (4) or the manuel extension module (3) by means of the fixing bolt (1.4) thereon.
Bone fixator according to Claim 1 , characterized in comprising a modular sliding clamp (2) which
Fixes the shaft of long bones with bone screw cannels (2.3) located at the same axis and the conical fixing screws (2.2) located 90 degrees to the nail channels; moves sliding on the extension module by means of the sliding channel (2.3) located 90 degrees to the bone nail channels;
can be fixed in different positions to the alternating channels (3.2) on the extension module by two eccentric screws (2.1) that are 90 degrees and connected to the sliding channel.
Bone fixator according to Claim 1, characterized in that the modular correction module (8) of the fixator comprises
an adaptor (8.6) on one end for the metaphysis clamp (1) and second adaptor (8.7) for the extension module on the other end and a scale (8.1) located on the adaptor (8.7) body;
joint comprising single-planned and male/female parts and fixed at the desired angle by means of the joint screw (8.2);
reducer mechanism (8.4) enabling three dimensional fixation, which is located on the body of the female part of the joint and moves the joint by working together with the male part (8.5) of the joint.
Bone fixator according to Claim 1 , characterized in that the smart ball socket joint (4) of the fixator comprises
elliptic sphere clamping apparatus (4.2) close to rectangular prism for reducing superposition in roentgenography, made of rigid metal and sphere and socket shaft slot in the sphere clamping apparatus (4.2);
non-circular channels (4.6) on both narrow sides of the sphere clamping apparatus (4.2);
socket shaft (3.5) corresponding to the sphere and made of relatively softer material; reverse grooved binary screw (4.4) with alien wrench on one side, and two conical pushers .
9. Bone fixator according to Claim 8, characterized in that the smart ball-socket joint (4) comprises two conical pushers (4.5) and is in monoblock or modular structure.
10. Bone fixator according to Claim 8, characterized in that the modular articulated metaphysis clamp (1), on which the joint sphere (5) is fixed by means of the binary shaft (7.4) -conical (7.5) push complex and (instead of socket shaft) the socket (7.5) binary shaft channel (7.6) on the clamp ,
comprises sphere clamping apparatus (4.2) designed according to the form of the clamp;
can be directly mounted to the manual extension module (3); and
can be connected to the sphere slides by a radiolucent connection (7.2).
11. Bone fixator according to Claim 10, characterized in that modular articulated metaphysis clamp (1) can be connected to the extension module (3) by means of the joints of the system.
PCT/TR2015/000233 2014-05-27 2015-05-25 Unilateral bone fixator system enabling bone extension and three dimensional fixation WO2015183226A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2014/05924 2014-05-27
TR201405924 2014-05-27

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Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5320623A (en) 1991-07-16 1994-06-14 Orthofix S.R.1. Clamping coupling for an external fixator
US5342360A (en) 1991-11-05 1994-08-30 Orthofix S.R.L. Clamping coupling for an external fixator
US5437667A (en) 1992-11-10 1995-08-01 Innovative Orthopaedics, Manufacturing, Inc. Dynamic external fixator for the wrist
US5601551A (en) 1995-03-01 1997-02-11 Smith & Nephew Richards, Inc. Geared external fixator
EP0775468A1 (en) 1995-11-27 1997-05-28 Bristol-Myers Squibb Company Transport carriage for an external fixator
EP0695538B1 (en) 1994-08-05 1999-10-20 POHL, Anthony Philip External fixator for military use
US20020010465A1 (en) 2000-01-31 2002-01-24 Ja Kyo Koo Frame fixator and operation system thereof
EP1486174A2 (en) 2003-06-03 2004-12-15 Agee, John M. Trustee of the John M. Agee Trust dated August 15, 1996 External fixator for colles' fracture
EP0955928B1 (en) 1995-05-12 2005-03-30 Electro-Biology, Inc. External fixator for large bones
EP1239784B1 (en) 1999-08-30 2006-04-19 Smith & Nephew, Inc. Six axis external fixator strut
EP2085037A1 (en) 2008-02-01 2009-08-05 Stryker Trauma SA Telescopic strut for an external fixator
EP2085038B1 (en) 2008-02-01 2011-11-30 Stryker Trauma SA Ball joint for an external fixator
EP2417924A1 (en) 2010-08-11 2012-02-15 Stryker Trauma SA External fixator system
US8388619B2 (en) 2002-09-17 2013-03-05 Sixfix Inc. Unilateral fixator

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US5304177A (en) * 1992-06-26 1994-04-19 Dietmar Pennig Auxiliary device for osteosynthesis
IT1289103B1 (en) * 1996-05-15 1998-09-25 Orthofix Srl COMPACT EXTERNAL FIXER
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5320623A (en) 1991-07-16 1994-06-14 Orthofix S.R.1. Clamping coupling for an external fixator
US5342360A (en) 1991-11-05 1994-08-30 Orthofix S.R.L. Clamping coupling for an external fixator
US5437667A (en) 1992-11-10 1995-08-01 Innovative Orthopaedics, Manufacturing, Inc. Dynamic external fixator for the wrist
EP0695538B1 (en) 1994-08-05 1999-10-20 POHL, Anthony Philip External fixator for military use
US5601551A (en) 1995-03-01 1997-02-11 Smith & Nephew Richards, Inc. Geared external fixator
EP0955928B1 (en) 1995-05-12 2005-03-30 Electro-Biology, Inc. External fixator for large bones
EP0775468A1 (en) 1995-11-27 1997-05-28 Bristol-Myers Squibb Company Transport carriage for an external fixator
EP1239784B1 (en) 1999-08-30 2006-04-19 Smith & Nephew, Inc. Six axis external fixator strut
US20020010465A1 (en) 2000-01-31 2002-01-24 Ja Kyo Koo Frame fixator and operation system thereof
US8388619B2 (en) 2002-09-17 2013-03-05 Sixfix Inc. Unilateral fixator
EP1486174A2 (en) 2003-06-03 2004-12-15 Agee, John M. Trustee of the John M. Agee Trust dated August 15, 1996 External fixator for colles' fracture
EP2085037A1 (en) 2008-02-01 2009-08-05 Stryker Trauma SA Telescopic strut for an external fixator
EP2085038B1 (en) 2008-02-01 2011-11-30 Stryker Trauma SA Ball joint for an external fixator
EP2417924A1 (en) 2010-08-11 2012-02-15 Stryker Trauma SA External fixator system

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