LINEAGE A-CLASS POLY LINER

K052026 · Wrightmedicaltechnologyinc · LPH · Dec 5, 2005 · Orthopedic

Device Facts

• Record ID: K052026
• Device Name: LINEAGE A-CLASS POLY LINER
• Applicant: Wrightmedicaltechnologyinc
• Product Code: LPH · Orthopedic
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LINEAGE® A-CLASS™ Poly Liner is 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: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; - correction of functional deformity; and, - revision procedures where other treatments or devices have failed

Device Story

The LINEAGE® A-CLASS™ Poly Liner is an acetabular component for total hip arthroplasty. It is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and features a locking mechanism to secure the liner into the acetabular shell. The device is available with 0° and 15° overhangs. It is intended for use by orthopedic surgeons in clinical settings. The device is designed to reduce wear compared to traditional liners, with bench testing demonstrating 94% less wear in a hip simulator over 5 million cycles. The output is a physical implant that replaces the worn or damaged acetabular surface, aiming to improve hip function and reduce pain for the patient.

Clinical Evidence

Bench testing only. In vitro hip wear simulator testing compared the LINEAGE® A-CLASS™ Poly Liner to the predicate LINEAGE® Poly Liner using 28 mm acetabular liners over 5 million cycles. The test device exhibited 424.7 mg less wear than the control. No clinical data provided; in vitro results are not shown to quantitatively predict clinical wear performance.

Technological Characteristics

Material: Ultra High Molecular Weight Polyethylene (UHMWPE). Form factor: Acetabular liner with 0° or 15° overhangs. Locking mechanism for acetabular shell integration. Sterilized. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, or revision procedures.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• LINEAGE® Poly Liner (K052026)

Submission Summary (Full Text)

{0}------------------------------------------------

## DEC 5 2005

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe m accordance with the 2 oct and in conformance with 21 CRF 807, this information serves as a Moural Devices for of Safety and Effectiveness for the LINEAGE® A-CLASS™ Poly Liner.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 5, 2005 |
| Contact Person: | Theresa Leister<br>Regulatory Affairs Specialist |
| Proprietary Name: | LINEAGE® A-CLASS™ Poly Liner |
| Common Name: | Poly Acetabular Component |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer, semi-<br>constrained, cemented prosthesis - Class II |
| | 21 CFR 888.3358 Prosthesis, Hip, Semi-<br>Constrained, metal/polymer, Uncemented -- Class II |
| | 21 CFR 888.3353 Prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented-- Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ IDI LZO LPH |

### DEVICE INFORMATION

#### A. INTENDED USE

The LINEAGE® A-CLASS™ Poly Liner is 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:

- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 】. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- 3. correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.

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

{1}------------------------------------------------

Page 24

## B. DEVICE DESCRIPTION

The design features of the LINEAGE® A-CLASS™ Poly Liner are summarized below:

- Ultra High Molecular Weight Polyethylene (UHMWPE) .
- Oura High Morecular Wolferal lip assembly to lock the liner into the actabular . shell
- Offered with 0° and 15° overhangs .

#### Wear Claim

The following marketing claim will be made for the LINEAGE® A-CLASS™ Poly Liner:

- The LINEAGE® A-CLASS™ Poly Liner exhibits 94% less wear than traditional . LINEAGE® Liners.*
## *Wear Test Information

- (a) The LINEAGE® A-CLASS™ Poly Liner and the LINEAGE® Poly Lincr arc manufactured by Wright Medical Technology, Inc.
- (b) The test device was the LINEAGE® A-CLASS™ Poly Liner and the control device was the LINEAGE® Poly Liner
- (c) Both the test and control devices were 28 mm inner diameter acetabular liners.
- (d) The articulating surfaces of both the test and control device have the same finish.
- (e) The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc.
- (f) Both the test and control devices were tested for 5 million cycles.
- (g) The material of the device was Ultra High Molecular Weight Polyethylene.
- (h) The lubricant used was 90% alpha calf serum with 0.2% sodium azide, 20mM EDTA and distilled water.
- (i) The average amount of wear at 5 million cycles for the test device was 424.7 mg less than that of the control device.
- (j) Both the test and control devices were sterilized.
- (k) The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and design features of the LINEAGE® A-CLASS™ Poly Liner are identical to the indications for use of the currently marketed LINEAGE® poly liner. The material used to manufacture the LINEAGE® A-CLASS™ Poly Liner is substantially equivalent to that which is used to manufacture the currently marketed LINEAGE® poly liner. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the LINEAGE® A-Class Poly Liner are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

{2}------------------------------------------------

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 representation of a human figure with three overlapping profiles, symbolizing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 DEC 2

Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K052026/S1

Trade/Device Name: LINEAGE® A-CLASS™ Poly Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDI, LZO Dated: October 6, 2005 Received: October 7, 2005

Dear Ms. Leister:

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 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.

{3}------------------------------------------------

Page 2- Theresa Leister

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wrif anow you to ough mating of substantial equivalence of your device to a legally prematics notinoadon: "The Presults 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 If you desire spocitie as not 12. J at [phone]. Also, please note the regulation entitled, Connact the Ories of Coursemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational 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,

s M. N. M

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K052026

Device Name:_LINEAGE® A-CLASS™ Poly Liner

Indications For Use:

Indications For Use:
The LINEAGE® A-CLASS™ Poly Liner is indicated for use in total hip arthroplasty with The LINEAGE® A-CLASS™ Poly Liner is indicated for use in comments
reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- the following conditions:
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis,
1. non-inflammatory de decided in a basinfid his dysplasi nori-inflantinatory "degential on" painful hip dysplasia;
ankylosis, protrusio acetabuli, and painful as rhoumet
- ankylosis, protrusio accadoni, and paint disease such as rheumatoid arthritis;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
2. inflammatory degene
- 2. Innummitatory functional deformity; and,
- 3. correction of fullchonal deformly, and,
4. revision procedures where other treatments or devices have failed

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)

Sim Off

ion Sign-Division of General. Restorative, and Neurological Druses

Page 1 of 1___

**510(k) Number** K052026

I