LINEAGE HA ACETABULAR SHELLS

K043099 · Wrightmedicaltechnologyinc · KWA · Sep 29, 2005 · Orthopedic

Device Facts

• Record ID: K043099
• Device Name: LINEAGE HA ACETABULAR SHELLS
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The LINEAGE® HA Acetabular Shells are single use components, intended for use as part of an uncemented total hip arthroplasty system; in conjunction with WMT's poly or metal liners; and ceramic or metal femoral heads.

Device Story

LINEAGE® HA Acetabular Shells are orthopedic implants for total hip arthroplasty; designed for uncemented fixation. Device consists of previously cleared acetabular shells modified with a Hydroxylapatite (HA) coating. Used by orthopedic surgeons in clinical settings to replace damaged acetabular bone surfaces; functions as a component of a hip prosthesis system alongside liners and femoral heads. HA coating promotes osseointegration; intended to reduce pain and restore hip function in patients with degenerative joint disease or fractures. Single-use device.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by materials data and bench testing results.

Technological Characteristics

Acetabular shell implant; features Hydroxylapatite (HA) coating. Designed for uncemented total hip arthroplasty. Compatible with WMT poly or metal liners and ceramic or metal femoral heads. Single-use.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity correction, revision procedures, or treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement.

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).

Submission Summary (Full Text)

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SEP 2 9 2005

Image /page/0/Picture/1 description: The image shows the word "WRIGHT" in large, bold letters at the top. Below the word, there is a graphic design. Underneath the graphic design, the text "K043099" is written in cursive. The text "Page 1 of 2" is written in cursive on the right side of the image. The words "MARY" and "FECTIVENESS" are written on the left side of the image.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LINEAGE® HA Acetabular Shell.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 06, 2004 |
| Contact Person: | Jeanine H. Redden<br>Regulatory Affairs Specialist II |
| Proprietary Name: | LINEAGE® HA Acetabular Shells |
| Common Name: | Acetabular Shells |
| Classification Name and Reference: | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate- Class II<br>21 CFR 888.3358 Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Class II<br>21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular component prosthesis - Class III |
| Device Product Code and Panel Code: | Orthopedics/87/MEH/LPH/KWA |

### DEVICE INFORMATION

### A. INTENDED USE

The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5. with head involvement that are unmanageable using other techniques.

## headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington. TN 38002 901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011-33-1-45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

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Page 24

The LINEAGE® HA Acetabular Shells are single use components, intended for use as part of an uncemented total hip arthroplasty system; in conjunction with WMT's poly or metal liners; and ceramic or metal femoral heads.

#### B. DEVICE DESCRIPTION

A Hydroxylapatite (HA) coating is being added to the LINEAGE® Acetabular Shells previously cleared for market in the US.

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The LINEAGEE® HA Acetabular Shells are substantially cquivalent to the predicate devices previously cleared for market. The safety and effectiveness of the LINEAGLI:® HA Acetabular Shells is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, next to a circular seal. The seal contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter of the circle.

SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanine H. Redden Senior Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K043099

Trade/Device Name: LINEAGE® HA Acetabular Shells Regulation Numbers: 21 CFR 888.3330 Regulation Names: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, LPH, MEH Dated: August 15, 2005 Received: August 26, 2005

Dear Ms. Redden:

We have reviewed your Scction 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 complics 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Jeanine H. Redden

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/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Mark A. Milliken

Mark 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 Indications for USE Ko430999

Device Name: LINEAGE® HA Acetabular Shells

Indications For Use:

The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and, 3.
- 4. revision procedures where other treatments or devices have failed
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with 5. head involvement that are unmanageable using other techniques.

The LINEAGE® HA Acetabular Shells are intended for single patie

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

510(k) Number K04307

Prescription Use (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)

Page 1 of /

headquarters Wright Medical Technology, Inc.

Arlinaton. TN 38002 5677 Airline Road

901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

011.81.3.3538.0474 Japa

011.33.1.45.13.24.40 Fran 011.44.1483.721.404 UK

011.49.4161.745130 Germany