EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED

K033634 · Centerpulse Orthopedics, Inc. · KWA · Sep 15, 2004 · Orthopedic

Device Facts

• Record ID: K033634
• Device Name: EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
• Applicant: Centerpulse Orthopedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Sep 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The 32mm Epsilon Metasul Acetabular Insert and Metasul Femoral Head are intended for use in total hip arthroplasty for treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis, and inflammatory joint disease (JJD), e.g., rheumatoid arthritis: - those patients with failed previous surgery where pain, deformity, or dysfunction . persists: - . revision of previously failed hip arthroplasty.

Device Story

Total hip replacement system consisting of 32mm acetabular insert and modular femoral head. Acetabular insert features 'polysandwich' design: UHMWPE outer shell thermo-mechanically bonded to mirror-finished CoCr alloy metallic inlay. Femoral head manufactured from wrought forged CoCrMo alloy with 12/14 Morse-type female taper. System functions as metal-on-metal bearing; natural synovial fluid provides lubrication. Hooded insert variants include 20° polyethylene overhang to resist subluxation. Used in orthopedic surgery; implanted by surgeons. Provides stable articulation for hip joint; intended to restore function and reduce pain in patients with degenerative or inflammatory joint disease.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: UHMWPE (ASTM F648) and wrought hot-forged CoCr alloy (ISO 5832-12). Design: Hemispherical acetabular insert with metallic inlay; modular femoral head with 12/14 Morse-type taper. Bearing: Metal-on-metal. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for total hip arthroplasty in patients with noninflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis), inflammatory joint disease (e.g., rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or revision of failed hip arthroplasty.

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).

Predicate Devices

• Centerpulse Orthopedics Epsilon Metasul Acetabular Insert, 28mm Standard (K974728)
• Centerpulse Orthopedics Epsilon Metasul Acetabular Insert, 28mm Hooded (K001526)
• Centerpulse Metasul Modular Femoral Head (K974728)
• Biomet M2a Ringloc Acetabular Liner (K002379)
• Biomet M2a-Taper Acetabular System (K003363)
• Biomet M2a-Taper Acetabular System (K993438)
• J&J DePuy Ultamet Femoral Heads (K980513)

Submission Summary (Full Text)

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K033634

510(k) Premarket Notification

32mm Epsilon Metasul Acetabular Insert and 32mm Metasul Femoral Head, as amended

## 510(k) SUMMARY

| SPONSOR NAME: | Centerpulse Orthopedics, Inc., a division of Zimmer<br>9900 Spectrum Drive<br>Austin, TX 78717 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Audrey Swearingen<br>Phone: [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | Epsilon™ Metasul® Acetabular Insert and Metasul Modular<br>Femoral Head |
| COMMON NAME: | Total hip replacement system acetabular insert and head |
| CLASSIFICATION: | CFR §888.3330 (KWA) - Hip joint metal/metal<br>semiconstrained, with an uncemented acetabular<br>component, prosthesis, reviewed by the Orthopedic Devices<br>panel. Metal-on-metal hip prostheses are Preamendment<br>Class III devices. |

#### PREDICATE DEVICES:

- Centerpulse Orthopedics Epsilon Metasul Acetabular Insert, 28mm Standard � (K974728) and Hooded (K001526)
- Centerpulse Metasul® Modular Femoral Head (K974728) .
- Biomet M2a™ Ringloc® Acetabular Liner (K002379) .
- Biomet M2a -Taper" Acetabular System (K003363, K993438, unknown) ●
- J&J DePuy Ultamet Femoral Heads (K980513) .

## DEVICE DESCRIPTION:

The Epsilon Metasul 32mm Acetabular Insert is a hemispherically shaped design, composed of an outer component manufactured from polyethylene (UHMWPE) (in compliance with ASTM F648) which is thermo-mechanically bonded to a wrought hotforged CoCr alloy metallic inlay (in compliance with ISO 5832-12). The Epsilon Metasul Acetabular Insert is designed for use only with a Metasul femoral head component, as a metal-on-metal system. The body's natural synovial fluid lubricates the metal surfaces. The Epsilon Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes designed to mate with Converge® Acetabular Shells, sizes 53mm to 81mm (in 2mm increments).

The Epsilon Metasul 32mm Insert has what is commonly referred to as a "polysandwich" design. The inner diameter, which forms the bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and thermomechanically bonded into the polyethylene liner, which is then locked into the Converge acetabular shell via the proven snap mechanism. On the hooded inserts, the face of the polyethylene outer diameter incorporates a 20° overhang of polyethylene extending superiorly from the midpoint of the insert face. This hood feature is designed to provide additional resistance to subluxation and instability.

The 32mm Metasul® Modular Femoral Head is manufactured from Protasul-21WF

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(wrought forged CoCrMo, in compliance with ISO 5832-12). The design incorporates a 12/14 Morse-type female taper and a beveled face that allows for easier reduction of the hip intraoperatively. This femoral head component is offered in both a standard and an eccentric version, and is designed specifically to articulate with Centerpulse Orthopedics acetabular inserts having a Metasul® Inlav.

# INTENDED USE:

The 32mm Epsilon Metasul Acetabular Insert and Metasul Femoral Head are intended for use in total hip arthroplasty for treatment of the following:

- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis, and inflammatory joint disease (JJD), e.g., rheumatoid arthritis:
- those patients with failed previous surgery where pain, deformity, or dysfunction . persists:
- . revision of previously failed hip arthroplasty.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, indications for use and labeling of the 32mm Epsion Metasul Acetabular Insert and Metasul Femoral Head demonstrate that they are substantially equivalent in terms of design features, materials, and indications for use to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing snakes wrapped around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K033634

KU35034
Trade/Device Name: Epsilon™ Metasul® Acetabular 32mm Insert/Femoral Head Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: August 23, 2004 Received: August 24, 2004

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in we nave reviewed your bector 9 rQst, presidentially equivalent (for the indications felerenced above and nave determined two marketed predicate devices marketed in interstate for use stated in the encrosury manatiment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Red Ford, Free L. Days commerce prior to May 20, 1976, the enaounce with the provisions of the Federal Food, Drug, devices that have been recults in access approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Art. The You may, merelove, market the dovice, adoject to an any and registration, listing of t gencial controls provided or wactice, 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 If your device is classified (500 above) ins existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contribution may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood on reacts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of wouldevice complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally reachar statutes and regulations and adding, but not limited to: registration and listing (21 comply with an the Ace 3 requirements) news and manufacturing practice requirements as set CITY art 6077, labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 form in the quality bybelins (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Audrey Swearingen

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your a comming of substantial equivalence of your device to a legally premated predicated 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 If you desire specific 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 other general mitormational 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,

Miriam C. Provost

Celia Witten, Ph.D., M.D. 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): K033634

Device Name:

Epsilon™ Metasul® 32mm Acetabular Insert

Indications for Use:

The Epsilon™ Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following:

- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . osteoarthritis, post-traumatic arthritis or avascular necrosis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- those patients with failed previous surgery where pain, deformity, or dysfunction . persists;
- revision of previously failed hip arthroplasty. .

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

KO33634 510(k) Number_

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(Posted November 13, 2003)