APR METASUL ACETABULAR INSERT

K993569 · Sulzermedica · KWA · Dec 1, 1999 · Orthopedic

Device Facts

• Record ID: K993569
• Device Name: APR METASUL ACETABULAR INSERT
• Applicant: Sulzermedica
• Product Code: KWA · Orthopedic
• Decision Date: Dec 1, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads 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 (IJD), e.g., rheumatoid arthritis. - those patients with failed previous surgery where pain, deformity, or dysfunction persists. - revision of a previously failed arthroplasty.

Device Story

Modular hemispherical acetabular insert for total hip arthroplasty; consists of UHMWPE outer shell (ASTM F648) with integrated metallic Metasul inlay (CoCrMo alloy, ISO 5832-4/12). Inlay polished to mirror-finish; hot-pressed into polyethylene backing; optional CoCr alloy pins (ASTM F562) provide rotational stability. Device mates with previously cleared APR metallic acetabular shells and Metasul femoral heads. Used by orthopedic surgeons in clinical settings to replace damaged hip joint surfaces; provides bearing surface for hip prosthesis. Benefits include reduced wear properties compared to standard polyethylene inserts. No software or electronic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control requirements, material specifications, and comparison to previously cleared predicate systems.

Technological Characteristics

Modular acetabular insert; UHMWPE (ASTM F648) outer shell; Protasul-21WF (CoCrMo alloy, ISO 5832-4, ISO 5832-12) inlay; Protasul-10 (CoCr alloy, ASTM F562) pins. Hemispherical form factor; 49mm-81mm OD; 28mm ID. Mechanical locking features for shell integration. No software, electronics, or connectivity.

Indications for Use

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

• APR Acetabular System
• Inter-Op Metasul Acetabular System

Submission Summary (Full Text)

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DEC - I 1999

## 510(k) SUMMARY

| Sponsor: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Mitchell Dhority, RAC<br>Manager, Regulatory and Clinical Affairs |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous coated<br>uncemented prosthesis, 21 CFR 888.3358 |
| Common/Usual Name: | Total Hip Prosthesis, Semi-constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics APR Metasul Acetabular Inserts |

### PRODUCT DESCRIPTION

The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells.

The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components.

The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.

## INTENDED USE / DIAGNOSTIC INDICATIONS

The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads 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 (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed arthroplasty. .

## SUBSTANTIAL EQUIVALENCE

Substantial equivalence is based on a direct comparison to the commercially APR Acetabular System and Inter-Op Metasul Acetabular System. The fundamental scientific technologies

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incorporated into these two products has not changed in the APR Metasul Acetabular Insert. Based on conformance with the design control requirements as specified in 21 CFR 820.30 and similarities in design, materials, sterilization, method of manufacture, intended use and indications for use, we believe that the APR Metasul Acetabular Insert is substantially equivalent to the previously cleared APR Acetabular System and Inter-Op Metasul Acetabular System.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1999

Mitchell A. Dhority, RAC Manager, Regulatory and Clinical Affairs Sulzer Medica Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717

K993569 Re: APR Metasul Acetabular Insert Trade Name: Requlatory Class: III Product Code: KWA Dated: November 15, 1999 November 16, 1999 Received:

Dear Mr. Dhority:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mitchell A. Dhority, RAC

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Irvine F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____gg3569

Device Name: APR Metasul Acetabular Inserts

# Indications for Use:

The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:

- 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis.
- 2. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- 3. Revision of previously failed hip arthroplasty.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K943569 |

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