INTER-OP METASUL ACETABULAR SYSTEM

K974728 · Sulzer Orthopedics, Inc. · KWA · Aug 3, 1999 · Orthopedic

Device Facts

• Record ID: K974728
• Device Name: INTER-OP METASUL ACETABULAR SYSTEM
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Aug 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following: - Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis. - Those patients with failed previous surgery where pain, deformity or dysfunction persists. 2. - Revision of previously failed hip arthroplasty. 3.

Device Story

Inter-Op Metasul Acetabular System is a total hip replacement component system consisting of a UHMWPE acetabular insert with an integral CoCrMo metal inlay and a CoCrMo femoral head. The device is used by orthopedic surgeons in a clinical/OR setting to replace a diseased or failed hip joint. The metal inlay is hot-pressed into the polyethylene backing and secured with CoCr pins for rotational stability. The femoral head features a 12/14 morse taper for connection to femoral stems. The system provides a metal-on-metal articulating surface designed for high-precision performance. By restoring joint function and reducing pain, the device benefits patients suffering from degenerative joint disease or failed prior arthroplasty.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparisons to preamendments predicate devices.

Technological Characteristics

Acetabular insert: UHMWPE (ASTM F648) with Protasul-21WF (CoCrMo, ISO 5832) inlay and Protasul-10 (CoCr, ASTM F562) pins. Femoral head: Protasul-21WF (CoCrMo, ISO 5832). Features 12/14 morse taper. Articulating interface requires high-precision manufacturing tolerances.

Indications for Use

Indicated for total hip replacement in patients with non-inflammatory degenerative joint disease (osteoarthritis, post-traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (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

• McKee-Farrar Total Hip
• Ring Total Hip
• Sivash Total Hip

Submission Summary (Full Text)

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K9 74728

#### 510(k) SUMMARY

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) summary for the Sulzer Orthopedics Inc. Inter-Op Metasul Acetabular System.

| Submitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, TX 78717<br>[phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes<br>Manager, Regulatory Affairs |
| Classification Name: | CFR 888.3330 - Hip joint metal/metal semiconstrained, with an<br>uncemented acetabular component, prosthesis |
| Common/Usual Name: | Acetabular insert and head component of a total hip replacement |
| Trade/Proprietary Name: | Inter-Op Metasul Acetabular System |

#### PRODUCT DESCRIPTION:

The Inter-On Acetabular System is comprised of two components: (1) a polyethylene acetabular insert with an integral Metal inlay (inner diameter), and (2) a Metasul femoral head.

### Inter-Op Metasul Acetabular Insert

The Inter-On Metasul Acetabular Insert is a hemispherical polyethylene component manufactured from UHMWPE (ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared Inter-Op metallic acetabular shells.

The inner diameter which forms the bearing surface of the insert features a metallic Metasul inlay that is integrally locked to the polyethylene insert. The metal inlay is manufactured from Protasul -21WF, a wrought forged CoCrMo alloy (ISO 5832). This inlay is polished to a mirrorfinish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins are press fit into the design of the inlay to help provide added rotational stability. The Metasul inlay is designed for use only with the Metasul head component.

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

#### Metasul Femoral Head

The Metasul Femoral Heads are manufactured from the same Protasul-21WF (CoCr, ISO 5832) material as the metal inlay of the acetabular component. The design incorporates a 12/14 morse type female taper with beveled face for ease of reduction intraoperatively. The female taper matches the 12/14 male taper used on Sulzer Orthopedics femoral stems.

The Metasul femoral heads are designed specifically to articulate with the Metasul inlay of the High precision manufacturing allows for optimal articulating surface acetabular component.

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geometry (e.g., clearance between the Metasul head and the Metasul inlay). These devices are manufactured within tight tolerances because the success of the system is dependent on optimal performance at this articulating interface

The Metasul heads are available in 28mm diameter with four neck lengths: short (-4mm), medium (neutral), long (+4mm) and extra long (+8mm).

## SPECIFIC DIAGNOSTIC INDICATIONS:

The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following:

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

#### SUBSTANTIAL EQUIVALENCE:

Substantial equivalence determination is based on comparison of the Inter-Op Metasul Acetabular System to the following preamendments predicate devices:

- McKee-Farrar Total Hip 1
- Ring Total Hip L
- Sivash Total Hip

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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 features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG = 3 1999

Mitchell A. Dhority, RAC Sr. Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

K974728 Re:

> Trade Name: Inter-Op™ Metasul® Acetabular System Regulatory Class: III Product Code: KWA Dated: May 20, 1999 Received: May 21, 1999

#### 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 control provisions of the Act. The general control 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice Requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug 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.

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.

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Page 2 - Mr. Mitchell A. Dhority

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]. Furthermore, for questions regarding 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. 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): K974728

Device Name: Inter-Op Metasul Acetabular System

# Indications for Use:

P

The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following:

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
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| (Division Sign-Off) | | | |
| Division of General Restorative Devices | | | |
| 510(k) Number | K994728 | | |
| Prescription Use | | OR | Over-the Counter Use |

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