The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures
Post-traumatic joint contracture which has resulted in loss of range of motion
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis or non-union of long bones
Limb lengthening by epiphyseal or metaphyseal distraction
Correction of bony or soft tissue deformity
Correction of segmental bony or soft tissue defects
Joint arthrodesis
Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

Osteotomy
Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Fusions and replantations of the foot
Charcot foot reconstruction
Lisfranc dislocations

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified telescopic strut and wire bolt components of the Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in K113327. The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.

AI/ML Overview

The Hoffmann LRF (Limb Reconstruction Frame) System, specifically the modified telescopic strut and wire bolt components, demonstrated substantial equivalence to predicate devices through non-clinical laboratory testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Component	Test Type	Acceptance Criteria	Reported Device Performance
Telescopic Strut	Dynamic Component Testing	Not explicitly detailed, but implied to meet performance comparable to the predicate device per ASTM F1541-02.	Met performance comparable to the predicate device.
Telescopic Strut	Static Component Testing	Not explicitly detailed, but implied to meet performance comparable to the predicate device per ASTM F1541-02.	Met performance comparable to the predicate device.
Telescopic Strut	Dynamic Construct Testing	Not explicitly detailed, but implied to meet performance comparable to the predicate device when integrated into a construct, per ASTM F1541-02.	Met performance comparable to the predicate device.
Telescopic Strut	Static Construct Testing	Not explicitly detailed, but implied to meet performance comparable to the predicate device when integrated into a construct, per ASTM F1541-02.	Met performance comparable to the predicate device.
Wire Bolt	Dynamic Construct Testing	Not explicitly detailed, but implied to meet performance comparable to the predicate device when integrated into a construct, per ASTM F1541-02.	Met performance comparable to the predicate device.
Wire Bolt	Pull Out Testing	Not explicitly detailed, but implied to demonstrate sufficient pull-out strength comparable to the predicate device, per ASTM F1541-02.	Met performance comparable to the predicate device.
Overall System	Substantial Equivalence to Predicate	The acceptance criterion was that the modified components, when tested, would demonstrate "substantial equivalence" in performance characteristics to the predicate device (Hoffmann LRF System - K113327) according to ASTM F1541-02. This means the new components should perform at least as well as, and not introduce new or different questions of safety or effectiveness compared to, the previously cleared device.	Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System modified components are substantially equivalent to the predicate device components previously cleared in K113327 (Hoffmann LRF System) and Ilizarov External Fixation System (K031181-Smith and Nephew).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the modified telescopic strut and wire bolt components," implying a sufficient number of components were tested to satisfy the requirements of ASTM F1541-02. The specific quantity of individual components tested is not provided.
Data Provenance: The testing was "non-clinical laboratory testing," indicating it was conducted in a controlled lab environment. The country of origin for the testing is not specified, but the sponsor, Stryker Trauma AG, is located in Switzerland. The documentation for the 510(k) submission was prepared in the U.S.
Retrospective or Prospective: Prospective, as the tests were conducted specifically for this submission to evaluate the modified components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This was non-clinical laboratory testing of device components, not a clinical study involving human patients or expert interpretation of medical images/data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was non-clinical, objective laboratory testing against established engineering standards (ASTM F1541-02), not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical Testing: Clinical testing was not required for this submission."

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical external fixation system, not a software algorithm or AI system. The "standalone" performance refers to the device components' mechanical properties. The non-clinical laboratory testing effectively serves as the standalone performance evaluation of the modified components.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was defined by the performance requirements and testing methodologies outlined in ASTM F1541-02 -- "Standard Specification and Test Methods for External Skeletal Fixation Device." The standard dictates how specific mechanical properties (e.g., dynamic and static strength, pull-out strength) should be measured and provides a framework for evaluating whether a device meets acceptable performance levels for its intended use. In this case, the ground truth was the objective mechanical properties as measured against the standard and compared to the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This was non-clinical mechanical testing, not a machine learning or AI study that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there was no training set.

Summary

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K130334

510(k) Summary

External Fixation Device

Proprietary Name:

Hoffmann LRF (Limb Reconstruction Frame) System

Common Name:

.
.

Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030

Regulatory Class:

Product Codes:

Sponsor:

Contact Information:

Class II

87 KTT-Appliance, fixation, nail/blade/plate combination, multiple component

Stryker Trauma AG Bohnackerweg I CH-2545 Selzach Switzerland

Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com

Date Prepared:

February 7, 2013

Description:

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K130334

Intended Use:

Indications:

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures .
Post-traumatic joint contracture which has resulted in loss of range of motion .
Fractures and disease which generally may result in joint contractures or loss of range . of motion and fractures requiring distraction
. Pseudoarthrosis or non-union of long bones
Limb lengthening by epiphyseal or metaphyseal distraction .
Correction of bony or soft tissue deformity ●
Correction of segmental bony or soft tissue defects .
Joint arthrodesis .
Management of comminuted intra-articular fractures of the distal radius ●

The Stryker Hoffmann LRF System is indicated in adults for:

Osteotomy .
Revision procedure where other treatments or devices have been unsuccessful .
Bone reconstruction procedures .
Fusions and replantations of the foot .
Charcot foot reconstruction .
. Lisfranc dislocations

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:

Hoffmann LRF (Limb Reconstruction Frame) System- K113327 .
Ilizarov External Fixation System (K031181-Smith and Nephew) .

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Non-Clinical Testing:

Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the modified telescopic strut and wire bolt components. Testing was performed with compliance to ASTM F1541-02 -- "Standard Specification and Test Methods for External Skeletal Fixation Device." Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System modified components are substantially equivalent to the predicate device components previously cleared in K113327. Testing included the following:

Telescopic Strut

Dynamic and Static Component Testing .
Dynamic and Static Construct Testing .

Wire Bolt

. Dynamic Construct Testing
Pull Out Testing .

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Stryker Trauma AG % Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K130334

Trade/Device Name: Hoffmann LRF (Limb Reconstruction Frame) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: April 8, 2013 Received: . April 9, 2013

Dear Ms. Celi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 – Ms. Estela Celi

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Erin - Meith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130334

Indications for Use

510(k) Number (if known):

Device Name: Hoffmann LRF (Limb Reconstruction Frame) System

Indications for Use:

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

. Open and Closed Fractures
Post-traumatic joint contracture which has resulted in loss of range of motion ●
Fractures and disease which generally may result in joint contractures or loss of range . of motion and fractures requiring distraction
Pseudoarthrosis or non-union of long bones ♥
Limb lengthening by epiphyseal or metaphyseal distraction .
Correction of bony or soft tissue deformity .
Correction of segmental bony or soft tissue defects .
Joint arthrodesis �
Management of comminuted intra-articular fractures of the distal radius ●

The Stryker Hoffmann LRF System is indicated in adults for:

Osteotomy .
Revision procedure where other treatments or devices have been unsuccessful .
Bone reconstruction procedures t
Fusions and replantations of the foot .
Charcot foot reconstruction .
Lisfranc dislocations .

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

107

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.