APEX HCLA ACETABULAR CUP LINERS

K062489 · Omnilife Science · LPH · Aug 15, 2007 · Orthopedic

Device Facts

• Record ID: K062489
• Device Name: APEX HCLA ACETABULAR CUP LINERS
• Applicant: Omnilife Science
• Product Code: LPH · Orthopedic
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex HCLA 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

Apex HCLA Acetabular Cup Liners are orthopedic implants for total hip replacement; used with Apex Modular Acetabular Cup and compatible hip stems. Liners articulate with 28mm cobalt chromium or alumina ceramic femoral heads. Device implanted by orthopedic surgeons in clinical/hospital settings. Compression-molded, cross-linked, stabilized UHMWPE construction provides wear resistance. Locking mechanism utilizes 19° taper and PE locking ring for secure shell engagement. Single-use device; provides stable bearing surface for hip joint; restores joint function; reduces pain for patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Compression-molded, cross-linked, stabilized UHMWPE. 28mm inner diameter. 19° taper and PE locking ring mechanism. Sterilized via ethylene oxide. Designed for cementless fixation in metal shells.

Indications for Use

Indicated for patients undergoing total hip replacement requiring cementless acetabular fixation. Conditions include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, and femoral neck or trochanteric fractures of the proximal femur.

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

• DePuy Marathon™ Cross-Linked Polyethylene Acetabular Cup Liners (K994415, K010171, and K033273)

Reference Devices

• Apex Modular UHMWPE Liners (K031110)

Submission Summary (Full Text)

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# 510(K) SUMMARY

## Apex HCLA™ Acetabular Cup Liners

## July 12, 2007

1. Submitter: OMNI life science™, Inc. 175 Paramount Drive Raynham, MA 02767

Contact: Edward Cheal, Ph.D. [phone] x413 (voice) [phone] (fax)

#### 2. Device Name

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

#### 3. Intended Use

The Apex HCLA 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 HCLA™ Acetabular Cup Liners are manufactured of compression molded, cross-linked 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, 28 mm diameter, with various offsets.

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### 5. Predicate Device Comparison

Substantial equivalence' is claimed to the DePuy Marathon™ Cross-Linked Polyethylene Acetabular Cup Liners (K994415, K010171, and K033273). The following table summarizes the similarities and differences between the subject Apex HCLA™ Acetabular Cup Liners and the predicate DePuy Marathon™ Acetabular Cup Liners:

| | Apex HCLA™<br>Liners | Apex Modular<br>UHMWPE Liners | DePuy<br>Marathon™ |
|-----------------------------------------------------------------------------------|----------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------|
| 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 | Metal wire locking<br>ring (Duraloc<br>shells) or taper and<br>PE locking ring<br>(Pinnacle® shells) |
| Minimum UHMWPE<br>thickness (within 45°<br>of apex)* | 12.0 mm | 6.0 mm | 6.0 mm |
| Liner options | Neutral and 10°<br>hooded | Neutral, 10° and<br>15° hooded | Neutral and<br>lateralized (neutral<br>and face changing) |
| Head diameters | 28 mm | 28 and 32 mm | 28, 32, 36 mm |
| MATERIALS | | | |
| Cross-linked<br>UHMWPE | Yes | No | Yes |
| Sterilization | Ethylene oxide | Ethylene oxide | Gas plasma |

*Minimum thickness values for Apex HCLA and Apex Modular liners account for manufacturing tolerances; minimum thickness for DePuy Marathon liners is based on published product literature.

The Apex Modular HCLA 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 similar to intended use, material one one pinnacle liners, and identical to the locking mechanism in the Apex Modular UHMWPE liners (K031110). While the UHMWPE in the Apex Modular liners was not crosslinked, the cross-linked UHMWPE of the subject device is Moddlar infors woo not crosslinked UHMWPE of the predicate DePuy Marathon™ liners.

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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 stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps.

AUG 1 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OMNI life science Inc. c/o Edward J. Cheal, Ph.D. Vice President of Research 175 Paramount Drive, Suite 302 Raynham, Massachusctts 02767

> K062489 Trade/Device Name: Apex HCLA 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: July 12, 2007 Received: July 13, 2007

Dear Dr. Cheal:

Re:

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.

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Page 2 - Edward J. Cheal, Ph.D.

i his 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara McLeod

Mark N. Melkers 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): K062489

Device Name: Apex HCLA™ Acetabular Cup Liners

Indications For Use:

The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K61™ 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.

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)

Jaubere Mueup Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K062489