INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)

K972393 · Sulzer Orthopedics, Inc. · LPH · Sep 19, 1997 · Orthopedic

Device Facts

• Record ID: K972393
• Device Name: INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Components of the Inter-Op HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement. While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component. Diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System include: - revision of a previously implanted acetabular prosthesis; - patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and, - inflammatory joint disease; e.g., rheumatoid arthritis.

Device Story

Inter-Op HA Porous Acetabular System is a cementless hip prosthesis component; replaces acetabulum during total hip arthroplasty. System comprises Ti-6Al-4V alloy shell with Hydroxylapatite (HA) coated Cancellous Structured Titanium (CSTi) porous coating for biological fixation; utilizes snap-in UHMWPE liner. Available in hemispherical and protrusio designs to address bone stock deficiencies. Used by orthopedic surgeons in clinical settings. Device provides mechanical support and biological interface for hip joint reconstruction; benefits patients by restoring joint function and addressing acetabular defects.

Clinical Evidence

Bench testing only. Evidence focused on mechanical integrity of the locking mechanism between the acetabular shell and insert, demonstrating strength comparable to currently marketed devices.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136) shell, UHMWPE (ASTM F648) liner, Hydroxylapatite (HA) coating on Cancellous Structured Titanium (CSTi). Design: Hemispherical and protrusio shell styles with snap-in liner locking mechanism. Fixation: Cementless, biological fixation via porous coating. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients undergoing total hip arthroplasty requiring acetabular replacement, including revision of previous prostheses, noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis, arthritis secondary to disease/anomalies), and inflammatory joint disease (e.g., rheumatoid arthritis).

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

• Inter-Op Porous Acetabular System (Sulzer Orthopedics Inc.)
• APR HA Porous Hip System (Sulzer Orthopedics Inc.)
• Natural-Hip HA (Sulzer Orthopedics Inc.)

Submission Summary (Full Text)

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SEP 1 9 1997

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Inter-Op™ HA Porous Acetabular System.

| Submitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|-------------------------------------------------------------------------------------------------------|
| Date: | May 19, 1997 |
| Contact Person: | Jacquelyn Hughes<br>Manager, Regulatory Affairs |
| Classification Name: | Hip Joint Metal/Polymer/Metal Semi-constrained<br>Porous-coated Uncemented Prosthesis, 21CFR 888.3358 |
| Common/Usual Name: | Biologically fixed metal-backed acetabular component |
| Trade/Proprietary Name: | Inter-Op™ HA Porous Acetabular System |

#### PRODUCT DESCRIPTION

The Inter-Op™ HA Porous Acetabular System consists of a Ti-6Al-4V alloy (ASTM F136) shell which utilizes a polyethylene snap-in liner. Hydroxylapatite (HA) coated Cancellous Structured Titanium™ (CSTi™) porous coating provides biological fixation in a cementless application. The shells are available in a variety of sizes and designs to address different clinical situations in both primary and revision arthroplasties. Inter-Op HA Porous Acetabular Components are recommended for use with all Sulzer Orthopedics total hip replacement devices.

The system includes two primary designs: (1) a hemispherical shell with an offset outer radius in the rim region, which permits the loads to be transmitted to the periphery of the outer surface; and (2) a hemispherical shell with two plugged screwholes. The plugs may be removed intraoperatively for additional screw fixation, if desired. A dome hole plug is also provided.

Two multi-holed shells designed for screw application are provided for those clinical situations in which deficient bone stock exists in the acetabulum. Those screwholes that are not utilized may be plugged after implantation. This shell is available in two designs: (1) a standard hemispherical cup, and (2) a protrusio cup which adds 10mm of thickness of the medial wall over a standard hemispherical cup to address protrusio deficiencies in the acetabulum. A dome hole plug is also provided.

All the shell designs share identical internal geometry and locking mechanism thereby accepting any of the acetabular liners designed for this system. The acetabular liner is manufactured from Ultra-High Molecular Weight Polyethylene, or UHMWPE (ASTM F648) and is offered in various configurations in order to address different clinical situations. The liners are also available in a variety of sizes to accommodate available femoral head components.

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The integrity of the locking mechanism Inter-Op HA Porous Acetabular Component was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.

### DIAGNOSTIC INDICATIONS

Components of the Inter-Op HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement.

While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component.

General diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System include:

- 제 revision of a previously implanted acetabular prosthesis;
- 피 patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and,
- 피 inflammatory joint disease; e.g., rheumatoid arthritis.

## SUBSTANTIAL EQUIVALENCE

The Inter-Op HA Porous Acetabular System is substantially equivalent to the predicate components of the Inter-Op Porous Acetabular System (Sulzer Orthopedics Inc.) and to the APR HA Porous Hip System (Sulzer Orthopedics Inc.) and the Natural-Hip HA (Sulzer Orthopedics Inc.).

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 1997

Lori Kleinschrodt Holder, RAC Requlatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K972393 Inter-Op™ HA Porous Acetabular System Requlatory Class: II Product Codes: LPH and MEH Dated: June 25, 1997 Received: June 26, 1997

Dear Ms. Holder:

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). This decision is based on consideration of the specific design of stem and coatinq composition detailed in this application. You may, therefore, market the device, subject to the qeneral controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

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#### Page 2 - Lori Kleinschrodt Holder, RAC

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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. 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Lori Kleinschrodt Holder, RAC

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,

C. Galda M. Witton, Ph.D.

Cella 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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K972393 510(k) Number (if known): Unknown

Device Name: Inter-Op™ HA Porous Acetabular System

# Indications For Use:

Components of the Inter-Op HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement.

While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component.

Diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System include:

- 트 revision of a previously implanted acetabular prosthesis;
- 트 patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and.
- 트 inflammatory joint disease; e.g., rheumatoid arthritis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use X OR Over-The-Counter Use (Division Sign-Off (Optional Format 1-2-96) Division of General Restorative Devi 510(k) Number.