OSS LES PROXIMAL FEMORAL COMPONENT

K021380 · Biomet, Inc. · JDI · May 28, 2002 · Orthopedic

Device Facts

• Record ID: K021380
• Device Name: OSS LES PROXIMAL FEMORAL COMPONENT
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: May 28, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement. Indications: 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2) Correction of varus, valgus or post traumatic deformity 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement 4) Ligament deficiencies 5) Tumor resections 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 7) Revision of previously failed total joint arthroplasty 8) Trauma This device is a single use implant.

Device Story

OSS Les Proximal Femoral Component is a surgical implant for proximal femoral or total femur replacement. It integrates with Biomet's Oncology Salvage System (OSS), utilizing diaphyseal segments, intramedullary stems, and distal femur/hinged knee components. Designed for orthopedic surgical use in patients with severe joint disease, trauma, or tumor-related bone loss. The device combines design features from previous OSS proximal femoral components. It is a single-use implant intended to restore joint function and stability, alleviate pain, and correct anatomical deformities. Surgeons select and implant the component during reconstructive orthopedic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence supported by engineering analysis.

Technological Characteristics

Metal/polymer semi-constrained hip prosthesis. Materials, surface finishes, and processing are similar to predicate devices. Designed for cemented or uncemented use as a proximal femoral component within the Oncology Salvage System.

Indications for Use

Indicated for patients requiring proximal femoral or total femur replacement due to avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, deformity (varus/valgus/post-traumatic), failed osteotomy/arthrosis/joint replacement, ligament deficiency, tumor resection, non-unions, femoral neck/trochanteric fractures, or trauma.

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

• Oncology Salvage System (K002757)

Submission Summary (Full Text)

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MAY 2 8 2002

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K0d21380
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#### Summary of Safety and Effectiveness

| Applicant/Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
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- Contact Person: Patricia Sandborn Beres Biomet Orthopedics, Inc. 56 Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: [phone] extension 1278 Fax: [phone]
Proprietary Name: OSS Les Proximal Femoral Component

Classification Name: Prosthesis, Hip, semi-constrained, metal/polymer, cemented (888.3350) and Prosthesis, Hip, semi-constrained, metal/polymer, uncemented (888.3358) - when used as proximal femoral

Legally Marketed devices to Which Substantial Equivalence is Claimed: Proximal Femoral Components previously cleared in 510(k) K002757 for the Oncology Salvage System.

Device Description: The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.

The OSS Les Proximal Femoral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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021380
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Indications For Use: The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:

- 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
- 2) Correction of varus, valgus or post traumatic deformity
- 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
- 4) Ligament deficiencies
- 5) Tumor resections
- 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 7) Revision of previously failed total joint arthroplasty
- 8) Trauma

Summary of Technologies: The materials, surface finishes, and processing of the OSS Les Proximal Femoral Component are similar to the predicate devices.

Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned.

Clinical Testing: None provided

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 8 2002

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet. Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021380

Trade Name: OSS Les Proximal Femoral Component Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: Class II Product Code: JDI and LPH Dated: April 24, 2002 Received: May 1, 2002

Dear Ms. Sandborn Beres:

We have reviewed your Section 510(k) premarket 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 May 20, 1970, the enabilities and of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, (Treefore, market the device, subject to the general controls provisions of the Act. The general thereofs, maintons 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 (PMA), it 11 your device to such 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 r load be actived a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or uny 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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#### Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicated 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

R. Mark N. Mdlkess

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): ├од 1380

## Device Name: OSS Les Proximal Femoral Component

#### Indications For Use:

The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement.

Indications:

- 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
- 2) Correction of varus, valgus or post traumatic deformity
- 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
- 4) Ligament deficiencies
- 5) Tumor resections
- 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 7) Revision of previously failed total joint arthroplasty
- 8) Trauma

This device is a single use implant.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

eral. Restorative and Neurological Devices

Over-The-Counter Use

(Optional Format 1-2-96)

510(k) Number K091380