HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM

K140961 · Stryker Trauma AG · KTT · Nov 10, 2014 · Orthopedic

Device Facts

• Record ID: K140961
• Device Name: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
• Applicant: Stryker Trauma AG
• Product Code: KTT · Orthopedic
• Decision Date: Nov 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

External fixation system for orthopedic reconstruction; consists of carbon/aluminum rings, segments, threaded rods, struts, bolts, wires, and pins. Used in clinical settings by surgeons for bone stabilization, lengthening, and deformity correction. Operates as mechanical frame; provides structural support for bone segments; allows distraction/compression via manual adjustment of struts and hinges. Benefits patients by enabling bone healing, realignment, and joint mobility restoration in complex trauma or deformity cases. System is modular; compatible with other Stryker external fixation components.

Clinical Evidence

No clinical data. Bench testing only. Testing included static and dynamic cantilever bending tests and dynamic frame testing per ASTM F1541-02 to verify mechanical integrity of additional components.

Technological Characteristics

Materials: carbon and aluminum. Components: rings, threaded rods, telescopic/constrained/universal/motor struts, hinges, bolts, washers, nuts. Mechanical fixation principle. Modular form factor. Sterilization: not specified. Software: none.

Indications for Use

Indicated for pediatric and adult patients for treatment/fixation of open/closed fractures, post-traumatic joint contracture, fractures/disease requiring distraction, pseudoarthrosis/non-union of long bones, limb lengthening, bony/soft tissue deformity or defect correction, joint arthrodesis, and distal radius comminuted intra-articular fractures. Adults only: osteotomy, revision procedures, bone reconstruction, foot fusions/replantations, Charcot foot reconstruction, and Lisfranc dislocations.

Regulatory Classification

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.

Predicate Devices

• Hoffmann LRF (Limb Reconstruction Frame) System (K113327, K130334, K130907)
• External Fixation System (Smith and Nephew) (K031181)

Reference Devices

• Monticelli Spinelli External Fixation System
• Hoffmann II External Fixation System
• Hoffmann II MRI External Fixation System
• Hoffmann 3 External Fixation System
• Apex Fixation Pins

Submission Summary (Full Text)

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

November 10, 2014

Stryker Trauma AG Ms. Nesli Karakaya Associate Regulatory Affairs Manager Bohnackerweg 1 CH-2545 Selzach Switzerland

Re: K140961 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: September 29, 2014 Received: October 8, 2014

Dear Ms. Karakaya:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Nesli Karakaya

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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140961

#### Device Name

Hoffmann LRF (Limb Reconstruction Frame) System

Indications for Use (Describe)

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 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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Proprietary Name: | Hoffmann LRF (Limb Reconstruction Frame) System |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Device |
| Classification Name and Reference: | Single/multiple component metallic bone fixation<br>appliances and accessories 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Codes: | KTT-Appliance, fixation, nail/blade/plate combination<br>multiple components |
| Sponsor: | Stryker Trauma AG<br>Bohnackerweg 1<br>CH-2545 Selzach<br>Switzerland |
| Contact Information: | Nesli Karakaya, RAC<br>Associate Regulatory Affairs Manager<br>Bohnackerweg 1<br>CH-2545 Selzach<br>Switzerland<br>Phone: [phone] Fax: [phone]<br>[e-mail] |
| Date Prepared: | April 10, 2014 |

### Description:

Originally 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 bolt offset adapters, pin bolts and pin adapters, and washers.

- Modifications to the previously cleared telescopic strut and wire bolt components, as part ● of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334.
- Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in . K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327.
- This Traditional 510(k) submission is being supplied to the U.S. FDA to provide ● authorization to market the inclusion of additional components to the previously cleared Hoffmann LRF (Limb Reconstruction Frame) System, in K130907. The additional components of this submission will consist of the following: constrained hinge strut,

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universal hinge strut, motor struts, spherical washer, hinge bolt, self-locking nut, half hinge, universal joint, adjustment instrument, slotted plate and buckle.

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, Hoffman II MRI and Hoffmann 3 External Fixation System, and the Apex Fixation Pins.

### Intended Use:

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.

### 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/ K130334/ K130907
- . External Fixation System (Smith and Nephew)- K031181

# Non-Clinical Testing:

Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the additional components and component compatibility. Testing was

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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 added components are substantially equivalent to the predicate device components. Testing included the following:

- Static Cantilever Bending Test ●
- Dynamic Cantilever Bending Test
- . Dynamic Frame 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.