SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM

K974558 · Biomet, Inc. · JDI · Mar 4, 1998 · Orthopedic

Device Facts

• Record ID: K974558
• Device Name: SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Salvage/Oncology Hip and Total Femur System is designed to replace the either the encire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions. The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component. All components of this system are indicated for use with bone cement.

Device Story

Modular orthopedic implant system for total or proximal femoral replacement; components include proximal 1/3 hip component (Letson or Finn styles), diaphyseal shaft, and Finn Knee components. Used in clinical settings by surgeons for patients with severe bone loss from oncology or revision surgery. System requires bone cement for fixation. Components are modular to allow customization based on resection needs; left and right configurations available. Provides structural support for limb salvage; restores joint function; reduces need for amputation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular metal/polymer hip and femoral prosthesis. Components include proximal hip segments, diaphyseal shafts, and knee segments. Designed for cemented fixation. Materials are standard orthopedic alloys and polymers. No electronic or software components.

Indications for Use

Indicated for patients requiring replacement of the entire femur or a large portion of the proximal femur due to severe bone loss, typically from oncological diagnoses or limb salvage following multiple revisions. Requires use with bone cement.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Biomet's Proximal Femoral Hip Replacement (K810258)
• Biomet's Mallory/Head Modular Calcar (K945115)
• Wright Medical Technology's S.O.S. Proximal Femur (K933281)

Submission Summary (Full Text)

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K9741558

MAR - 4 1998

## Summary of Safety and Effectiveness

- Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Total Femur Replacement

Prosthesis, Hip, semi-constrained, metal/polymer, cemented Classification Name: (888.3350)

Device Description: The Salvage/Oncology Hip and Total Femur System is designed to replace either the entire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions or trauma.

When total femoral replacement is indicated, a proximal 1/3 hip component, a diaphyseal shaft and Finn Knee components are necessary. When the device is used for hip replacement, a proximal 1/3 hip component and a femoral stem are required. Two styles of the proximal 1/3 hip component are available, the Letson Modular Proximal and the Finn Proximal Component. Both devices have left and right configurations to ensure proper alignment of components. The proximal 1/3 hip component devices can be used as a modular hip stem with a femoral stem in cases where large proximal femur bone resection is necessary but the knee joint is not involved. The stems compatible with the proximal components are the Finn Knee Modular Segmental Stem Components. The diaphyseal component is a shaft which connects a proximal 1/3 hip component to a knee component when the device is used for total femur replacement.

All components of this system are indicated for use with bone cement.

Potential Risks: The potential risks associated with this device are the same as with any ioint replacement device. These include, but are not limited to:

| Reaction to the bone cement | Blood vessel damage | Bone fracture |
|---------------------------------|----------------------------|----------------|
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disorders | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Breakdown of the porous surface | Tissue growth failure | Nerve damage |
| Dissociation of the components | | |

Substantially Equivalent Devices: Biomet's Proximal Femoral Hip Replacement 510(k) K810258 cleared 3/5/81; Biomet's Mallory/Head Modular Calcar 510(k) K945115 Cleared Wright Medical Technology's S.O.S. Proximal Femur 510(k) K933281 cleared 5/2/95: 6/7/94

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1998

Ms. Patricia Sandborn Beres Director, Requlatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K974558 Salvage/Oncology Hip and Total Femur System Trade Name: Regulatory Class: ı i Product Codes: JDI and KRO December 3, 1997 Dated: Received: December 5, 1997

Dear Ms. Beres:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with war the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K974558

## Device Name: Salvage/Oncoloqy Hip and Total Femur System

Indications For Use:

The Salvage/Oncology Hip and Total Femur System is designed to replace the either the encire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions.

The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component.

All components of this system are indicated for use with bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
|---------------------------------------|---|

(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | K974558 (Optional Format 1-2-96) |
|---------------|----------------------------------|
| | Over-The-Counter Use |