POROUS COATED ACETABULAR COMPONENTS

K050124 · Biomet, Inc. · KWA · Oct 4, 2005 · Orthopedic

Device Facts

• Record ID: K050124
• Device Name: POROUS COATED ACETABULAR COMPONENTS
• Applicant: Biomet, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Oct 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Cemented or non-cemented total hip replacement in cases of 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5) Revision procedures where other treatment or devices have failed. M2a™ Ring-Loc liners are only cleared for use in non-cemented acetabular shells. The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Device Story

Metallic, full-hemisphere acetabular shell components for total hip replacement; used with modular polyethylene liners and femoral head components taper-fitted to femoral stems. Implanted by orthopedic surgeons in clinical/OR settings. Device restores hip joint function; addresses degenerative disease, fractures, and revision needs. Constrained liners provide stability for high-dislocation-risk patients. Benefits include joint pain relief, functional correction, and improved stability in complex revision cases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic, full-hemisphere acetabular shell components; modular polyethylene liners; taper-fit femoral head interface. Uncemented or cemented configurations. No specific material standards or software components described.

Indications for Use

Indicated for skeletally mature individuals requiring primary or revision total hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric). Constrained liners indicated for patients at high risk of hip dislocation due to prior dislocation, bone/joint loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Ranawat Burstein® Total Hip System (K921277)
• Full Hemisphere Ring-Loc Liner (K920640)
• Expanded Indications for Non-cemented Porous Coated Hips (K030055)

Submission Summary (Full Text)

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K050124 page 1 of 2

OCT 4 - 2005

### 510(k) Summary

## Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name(s): Ranawat Burstein® Acetabular Components, Full Hemisphere Acetabular Components, Quadrant Sparing Shells, and McLaughlin™ +5 Acetabular System.

Common or Usual Name: Acetabular component for a total hip replacement

#### Classification Name:

- 1) Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
- 2) Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR 888.3330)
- 3) Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350)
- 4) Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
- 5) Hip joint metal/polmer/metal semi-constrained, porous-coated, uncemented prosthesis (21 C.F.R. 888.3358)

Device Product Code: KWZ, KWA, JDI, MAY, MEH, LPH

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The Logally mattained in this 510(k) submission are substantially equivalent to devices cleared through the following 510(k)s:

| Ranawat Burstein® Total Hip System | K921277 |
|----------------------------------------------------------|---------|
| Full Hemisphere Ring-Loc Liner | K920640 |
| Expanded Indications for Non-cemented Porous Coated Hips | K030055 |

Device Description: All devices are metallic, full-hemisphere, acetabular shell components. Each shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery.

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## 510(k) Summary Porous Coated Acetabular Components Page 2

Intended Use: Cemented or non-cemented total hip replacement in case of

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- 5) Revision procedures where other treatment or devices have failed.

M2a™ Ring-Loc liners are only cleared for use in non-cemented acetabular shells.

The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Summary of Technologies: The devices to be covered by this 510(k) for are geometrically similar or identical to devices previously covered by 510(k).

Clinical and Non-Clinical Testing: None provided

All trademarks are property of Biomet, Inc. except for the following: Ranawat/Burstein is a trademark of the Hospital for Special Surgery

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K050124 Trade/Device Name: Porous Coated Acetabular Components Regulation Number: 21 CFR 888.3330 Regulations: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, KWZ, LPH, MAY, MEH, and JDI Dated: September 19, 2005 Received: September 20, 2005

Dear Ms. Beres:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 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); good manufacturing practice requirements as set

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Page 2 - Ms. Patricia Beres

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.

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millican

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

1050124 510(k) Number (if known):

Device Name: Porous Coated Acetabular Components

Indications For Use: Cemented or non-cemented total hip replacement in cases of

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- 5) Revision procedures where other treatment or devices have failed.

M2a™ Ring-Loc liners are only cleared for use in non-cemented acetabular shells.

The indications for use of the constrained liners compatible with this system are as follow:

- The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millenson

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(Division Sign-Off) (Division of General, Restorative, and Neurological De

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**510(k) Number**