OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM

K983382 · Osteonics Corp. · MEH · Dec 11, 1998 · Orthopedic

Device Facts

• Record ID: K983382
• Device Name: OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
• Applicant: Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.

Device Story

Acetabular component system for hip arthroplasty; consists of metal shell and polyethylene cup insert. Shells feature dual-radius or hemispherical design with screw holes and hydroxyapatite (HA) or AD-HA coatings for cementless fixation. Inserts utilize wireless locking mechanism with barbs and scalloped areas for indexability. Used by orthopedic surgeons in clinical/hospital settings during total hip replacement or revision surgery. Device provides stable acetabular surface for femoral head articulation; restores joint function; alleviates pain associated with degenerative or traumatic hip disease. Surgeon selects appropriate shell/insert size and configuration based on patient anatomy and bone quality.

Clinical Evidence

Bench testing only. Mechanical testing of shell/insert locking mechanism and fatigue performance provided to demonstrate substantial equivalence. No clinical data presented.

Technological Characteristics

Shells: ASTM F-620 Titanium Ti6Al-4V ELI alloy; AD-HA (arc-deposited CP Ti + plasma-sprayed HA) or plasma-sprayed HA coating. Inserts: Ultra-high molecular weight polyethylene. Design: Dual-radius or hemispherical shell; wireless locking mechanism (barbs/scalloped areas). Sizes: Various diameters/offsets. Sterilization: Standard methods.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative, rheumatoid, post-traumatic arthritis, or late-stage avascular necrosis), revision of failed previous hip procedures, clinical management where arthrodesis/reconstruction is less likely to succeed, or cases with poor/inadequate acetabular bone stock.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Osteonics® Secur-Fit™-HA Acetabular Components
• Osteonics® Modular Acetabular Cup System
• Osteonics® Secur-Fit™ HA X'tra Acetabular Component System
• Osteonics® Threaded HA Acetabular Shells
• Osteonics® Omnifit® Series II Cup Inserts

Submission Summary (Full Text)

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DEC 1 1 1998

K983382

Osteonics® HA Generation II Acetabular Component System

510(k) Summary

# 510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® HA Generation II Acetabular Component System

#### Submission Information

Name and Address of the Sponsor Osteonics Corporation of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677 Marybeth Naughton Contact Person: Regulatory Affairs Team Member

Date of Summary Preparation:

#### Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Osteonics® HA Generation II Acetabular Component System

September 23, 1998

Artificial Acetabular Component

Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis 21 CFR §888.3353

#### Predicate Device Identification

The Osteonics® HA Generation II Acetabular Component System is substantially equivalent to the Osteonics devices, which have previously been determined substantially equivalent by FDA:

- Osteonics® Secur-Fit™-HA Acetabular Components (previously known as the . Osteonics® Secur-Fit™ AD-HA Acetabular Component System.
- Osteonics® Modular Acetabular Cup System. .
- Osteonics® Secur-Fit™ HA X'tra Acetabular Component System. .
- Osteonics® Threaded HA Acetabular Shells. .
- Osteonics® Omnifit® Series II Cup Inserts. .

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#### Device Description

The Osteonics® HA Generation II Acetabular Component System consists of single-use devices. Each Osteonics® HA Generation II Acetabular Component consists of two pieces: an Osteonics® HA Generation II Acetabular Shell and an Osteonics® Generation II Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.

The Osteonics® HA Generation II Acetabular Shells are characterized by the following features:

- A basic dual radius (Secur-Fit option) or hemispherical (Threaded option) design .
- The predicate interior geometry which allows a mating polyethylene insert size to be used ● with more than one shell size.
- A variety of screw hole patterns, including dome hole and peripheral screw holes.
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
- . Circumferential normalizations (Secur-Fit option) or Circumferential threads (Threaded option)
- . A wide range of sizes.
- . Osteonics' AD-HA coating (Secur-Fit option) or HA coating (Threaded option)
- � Compatibility with the Generation II Cup Insert

The Osteonics® Generation II Cup Inserts are characterized by the following features:

- A wireless locking mechanism which utilizes a continuous ridge which locks into a groove � on the interior of the mating shell.
- � A hemispherical geometry which is designed to maximize liner conformity to mating shell.
- � Increased indexability through mating of barbs on shell with scalloped areas on insert.

## Intended Use:

The Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA Generation Il Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.

#### Indications:

The indications for the Osteonics® HA Generation II Acetabular Components, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

- . Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

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- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as ● indicated by deficiencies of the acetabulum.
## Statement of Technological Comparison:

The substantial equivalence of the Osteonics® HA Generation II Acetabular Components to the predicate devices identified above-in terms of intended use, materials, and design features-is based on the following.

## Intended Uses:

The Osteonics® HA Generation II Acetabular Components, like the predicate acetabular components cited above, are intended for cementless fixation. The subject devices and the predicate devices share the same indications for use.

#### Materials:

The Osteonics® HA Generation II Acetabular Shells are fabricated from ASTM F-620 Titanium Ti6Al-4VEli Alloy which is different from the predicate acetabular shells cited above which are fabricated from ASTM F-67 CP Titanium, but identical to other Osteonics' products, such as the Osteonics Titanium Femoral Stems, which have a long history of biocompatibility and clinical performance. The Osteonics® Secur-Fit™ -HA Generation II Acetabular Shells feature Osteonics' AD-HA coating (arc-deposited CP Ti, beneath plasma-sprayed hydroxylapatite) as do predicate Osteonics® Secur-Fit™-HA Acetabular Shells, Osteonics® Modular Acetabular Component System, and Osteonics® Secur-Fit™-HA X'tra Acetabular Component System. The Osteonics® Threaded-HA Acetabular Generation II Acetabular Shell features the Osteonics' HA coating (plasma sprayed HA) as does the predicate Osteonics® Threaded-HA Acetabular Shells.

The Osteonics® Generation II Cup Inserts and the predicate Osteonics® Omnifit® Series II Cup Inserts are both manufactured from ultra-high molecular weight polyethylene.

## Design:

The Osteonics® HA Generation II Acetabular Shells maintain design features consistent with the predicate Osteonics® Acetabular Components as follows:

A basic dual radius (Secur-Fit™ option) or hemispherical (Threaded option) design.

- A variety of screw hole patterns, including dome screw holes and peripheral screw holes. .
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plug.
- . Circumferential normalizations (Secur-Fit™ option) or circumferential threads (Threaded option).
- . A wide range of sizes.
- Osteonics AD-HA coating (Secur-Fit™ option) or HA coating (Threaded option).
- A locking mechanism which maintains or exceeds the strength characteristics of predicate devices.

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The Osteonics® Generation II Cup Inserts are characterized by the following design features which are consistent with predicate inserts:

- Availability in 22mm, 26mm, and 32mm inner diameter with the same minimum . polvethylene thickness.
- Availability in 0 degree and 10 degree insert versions.
- Availability with 2mm offset and 6mm (eccentric offset configurations. .
- A comparable rotating locking mechanism to predicate devices which utilizes the mating of . barbs on the shell to scalloped areas on the insert.
- Indexability of insert within the shell to provide ease of alignment of mating insert/shell. .

#### Summary

Based on the similarities presented above, the supporting testing reproduced in Appendix C, and the fact that the Osteonics® HA Generation II Acetabular Components employ standard sterilization and packaging methods, the substantial equivalence of the Osteonics® HA Generation II Acetabular Components to other legally marketed, class II, acetabular components is demonstrated.

## Performance Data:

The performance characteristics of the "AD-HA" and "HA" coatings have been presented in predicate 510(k) submissions. Mechanical testing of the subject shell/insert locking mechanism and fatigue performance is provided in this submission and demonstrate substantial equivalence to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Ms. Marybeth Naughton Regulatory Affairs Team Member Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K983382 Re : Osteonics® HA Generation II Acetabular Component System Regulatory Class: II Product Code: MEH September 24, 1998 Dated: Received: September 25, 1998

Dear Ms. Naughton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the action ially 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 commerce prior comments or to devices that have been realour Bood in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based on rood, Bray, and the specific design of cup and coating composition detailed in this application. You may, therefore, composition accurically on one one al controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for rou may not labor on in enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable The data presented support equivalence with fixation." no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, 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, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. Marybeth Naughton

You may market your device under the above limitations as These devices would be considered not class II devices. 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 regulations 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 Drug 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 - Ms. Marybeth Naughton

obtained from the Division of Small Manufacturers Assistance obcained from the Drvibron or 6.041 or [phone] or at at its coll-free number (000) 350 actir on (00) 300 in.html".
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): ____________________________________________________________________________________________________________________________________________________

#### Device Name: Osteonics® HA Generation II Acetabular Component System

#### Indications For Use:

The Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.

#### Indications:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other ● procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- . Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paseda

(Division S Division of General Restorative Device 510(k) Number

Prescription Use X

OROver-The-Counter Use (per21CFR 801.109(Optional Format 1-2-96)