INTERFACE ACETABULAR CUP LINERS

K092443 · Omni Life Science, Inc. · LPH · Oct 23, 2009 · Orthopedic

Device Facts

• Record ID: K092443
• Device Name: INTERFACE ACETABULAR CUP LINERS
• Applicant: Omni Life Science, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interface™ Acetabular Cup Liners are intended for use with the Interface™ 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; . e 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

Interface™ Acetabular Cup Liners are modular components for total hip replacement systems. Manufactured from compression-molded ultrahigh molecular weight polyethylene (UHMWPE), these liners are designed to fit within an acetabular cup and articulate with metal (cobalt chromium) or ceramic (alumina) femoral heads (28, 32, or 36 mm diameters). The device features a 19° taper and PE locking ring for secure engagement within the shell, including a new 20° elevated rim option. Used in surgical settings by orthopedic surgeons, the device replaces damaged or diseased hip joint surfaces. By providing a stable, articulating bearing surface, the liner restores joint function and mobility, reducing pain associated with degenerative conditions or fractures. The device is intended for single-use implantation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and manufacturing similarities to legally marketed predicate devices.

Technological Characteristics

Materials: Compression-molded UHMWPE. Sterilization: Ethylene oxide. Design: Modular acetabular liner with 19° taper and PE locking ring. Compatibility: 28, 32, 36 mm femoral heads (cobalt chrome or alumina). Options: Neutral and 20° elevated rim. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients undergoing total hip replacement requiring acetabular reconstruction due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, revision of failed prior treatments, or femoral neck/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

• Interface™ (K031110)
• ApeX-LNK Poly™ (K062489 and K073150)
• Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774)

Submission Summary (Full Text)

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OCT 2 3 2009

# Interface™ Acetabular Cup Liners

## August 7. 2009

| 1. Submitter: | OMNI life scienceTM, Inc.<br>175 Paramount Drive<br>Raynham, MA 02767 |
|---------------|-----------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------|

- Contact: William McCallum [phone] x423 (voice) [phone] (fax)
#### 2. Device Name

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

#### 3. Intended Use

The Interface™ Acetabular Cup Liners are intended for use with the Interface™ 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;
- e 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 Interface™ Acetabular Cup Liners are manufactured of compression molded 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, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

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#### 5. Predicate Device Comparison

Substantial equivalence is claimed to the Interface™ (K031110), the ApeX-LNK Poly™ (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the similarities and differences between the subject Apex Modular Interface™ Acetabular System cup liners and the predicate cup liners:

| | Subject<br>UHMWPE<br>Liners | Interface™<br>UHMWPE Liners<br>(K031110) | ApeX-LNK Poly™<br>(K062489 and<br>K073150) | Zimmer Trilogy®<br>Acetabular<br>System |
|--------------------------------------------------------------|----------------------------------|------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------|
| INTENDED USE | | | | |
| Modular liner in<br>metal shell, primary<br>and revision THA | Yes, cementless | Yes, cementless | Yes, cementless | Yes, cementless |
| DESIGN | | | | |
| Liner engagement | 19° taper and PE<br>locking ring | 19° taper and PE<br>locking ring | 19° taper and PE<br>locking ring | Locking ring and<br>anti-rotation tabs |
| Liner options | 20° elevated rim | Neutral and 15°<br>elevated rim | Neutral and 10°<br>elevated rim | Neutral, 10°, and<br>20° elevated rim;<br>also offset, oblique,<br>and eccentric<br>options |
| Head diameters | 28, 32 and 36 mm | 28 and 32 mm | 28, 32, and 36 mm | 28, 32, and 36 mm |
| MATERIALS | | | | |
| Cross-linked<br>UHMWPE | No | No | Yes | No |
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Gas plasma |

### 6. Basis of Substantial Equivalence

The Interface™ 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 predicate Interface™ Acetabular Cup Liners (K031110) and the ApeX-LNK Poly™ Acetabular Cup Liners (K062489 and K073150). The material, manufacturing, sterilization and packaging methods are identical to those of the predicate Interface™ Acetabular Cup Liners. The 20° elevated rim liner option is equivalent to the 20° elevated rim option in the Zimmer Trilogy® Acetabular System.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of three overlapping human profiles facing right, with stylized waves or lines below them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OMNI Life Science, Inc. % Mr. William McCallum 175 Paramount Drive Raynham, Massachusetts 02767

#### Re: K092443

OCT 2 3 2009

Trade/Device Name: Interface™ Acetabular Cup Liners 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, LZO, MEH Dated: September 15, 2009 Received: September 18, 2009

Dear Mr. McCallum:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Mr. William McCallum

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Milkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K092443

#### Indications for Use

510(k) Number (if known):

Device Name: Interface™ Acetabular Cup Liners

Indications For Use:

The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2TM, 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)

Sonita 2 for MXN

ision Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092443

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