APEX-LNK POLY ACETABULAR CUP LINERS

K073150 · Omni Life Science, Inc. · LPH · Feb 27, 2008 · Orthopedic

Device Facts

• Record ID: K073150
• Device Name: APEX-LNK POLY ACETABULAR CUP LINERS
• Applicant: Omni Life Science, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 27, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ApeX-LNK Poly™ Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: - Non-inflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis; - Rheumatoid arthritis; ● - Correction of functional deformity: . - Congenital dislocation; ● - Revision procedures where other treatments or devices have failed; ● - Femoral neck and trochanteric fractures of the proximal femur. .

Device Story

Acetabular cup liner component for total hip replacement; used in combination with Apex Modular acetabular cup and specific hip stems. Device articulates with metal (cobalt chromium) or ceramic (alumina) femoral heads. Implanted by orthopedic surgeons in clinical/hospital settings. Provides bearing surface for hip joint; restores joint function; addresses degenerative disease, arthritis, deformity, dislocation, or fracture. Single-use implant.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and design/material comparisons to predicate devices.

Technological Characteristics

Compression molded, crosslinked, and stabilized UHMWPE. Sterilized via ethylene oxide. Compatible with 32mm and 36mm diameter femoral heads. Modular design with neutral and 10-degree hooded options.

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, or femoral neck/trochanteric fractures.

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

• Apex Modular (K031110)
• Apex HCLA (K062489)
• DePuy Marathon (K994415, K010171, K033273)
• DePuy AltrX (K062148)

Submission Summary (Full Text)

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K073150 (pg. 1 of 2)

# 510(K) Summary

FED 27 ....

# ApeX-LNK Poly™ Acetabular Cup Liners

November 7, 2007

| 1. Submitter: | OMNI life science™, Inc.<br>175 Paramount Drive<br>Raynham, MA 02767 |
|---------------|----------------------------------------------------------------------------|
| Contact: | Edward Cheal, Ph.D.<br>[phone] x413 (voice)<br>[phone] (fax) |

### 2. Device Name

| Proprietary Name: | ApeX-LNK Poly™ Acetabular Cup Liners |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Acetabular cup, uncemented |
| Classification Names: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis; and<br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis |
| Regulatory Class: | Class II per 21 CFR §888.3353 and 21 CFR §888.3358 |

#### 3. Intended Use

The ApeX-LNK Poly™ Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity: .
- Congenital dislocation; ●
- Revision procedures where other treatments or devices have failed; ●
- Femoral neck and trochanteric fractures of the proximal femur. .

## 4. Device Description

The ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, crosslinked and stabilized ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 32 mm diameter, with various offsets.

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K073150 (pg. 2 of 2)

510(K) Summary

## 5. Predicate Device Comparison

Substantial equivalence is claimed to the Apex Modular (K031110), the Apex HCLA (K062489), the DePuy Marathon™ (K994415, K010171, and K033273), and the DePuy AltrX™ acetabular cup liners (K062148). The following table summarizes the similarities and differences between the subject ApeX-LNK Poly™ Acetabular Cup Liners and the predicate Apex HCLA, the DePuy Marathon and the DePuy AltrX Acetabular Cup Liners:

| | ApeX-LNK Poly<br>Liners | Apex HCLA<br>Liners | DePuy Marathon<br>and AltrX | |
|----------------|-----------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------|----------------------------------------------------|
| INTENDED USE | Modular liner in<br>metal shell, primary<br>and revision total hip<br>replacement | Yes, cementless | Yes, cementless | Yes, cemented and<br>cementless |
| DESIGN | Liner engagement | 19° taper and PE<br>locking ring | 19° taper and PE<br>locking ring | Taper and PE<br>locking ring<br>(Pinnacle® shells) |
| Liner options | Neutral and 10°<br>hooded | Neutral and 10°<br>hooded | Neutral and<br>lateralized (neutral<br>and face changing) | |
| Head diameters | 32 and 36 mm | 28 mm | 28, 32, 36 mm | |
| MATERIALS | Cross-linked<br>UHMWPE | Yes | Yes | Yes |
| Sterilization | Ethylene oxide | Ethylene oxide | Gas plasma | |

#### 6. Basis of Substantial Equivalence

The ApeX-LNK Poly Acetabular Cup Liners described in this submission are substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. The locking mechanism is identical to the locking mechanism in the Apex Modular Acetabular Cup Liners (K031110) and the Apex HCLA Acetabular Cup Liners (K062489). The material, manufacturing, sterilization and packaging methods are identical to those of the Apex HCLA Acetabular Cup Liners.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is in black and white.

FEB 27 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OMNI Life Science™, Inc. % Dr. Edward Cheal Vice President of Research and Development 175 Paramount Drive Raynham, MA 02767

Re: K073150 Trade/Device Name: ApeX-LNK PolyTM Acetabular Cup Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: February 4, 2008 Received: February 5, 2008

Dear Dr. Cheal:

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 (21CFR 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 - Dr. Edward Cheal

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 N Millerson

Mark N. Melkerson 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

#### 510(k) Number (if known): K073150

Device Name: ApeX-LNK Poly™ Acetabular Cup Liners

Indications For Use:

The ApeX-LNK Poly Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; ●
- Rheumatoid arthritis;
- Correction of functional deformity; .
- Congenital dislocation; .
- Revision procedures where other treatments or devices have failed; .
- Femoral neck and trochanteric fractures of the proximal femur.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchner

Page 1 of 1

sion of General, Restorative. and Neurological Devices

**510(k) Number** K073150