OSTEONICS SHOULDER HUMERAL COMPONENTS

K955731 · Osteonics Corp. · KWS · Mar 5, 1996 · Orthopedic

Device Facts

• Record ID: K955731
• Device Name: OSTEONICS SHOULDER HUMERAL COMPONENTS
• Applicant: Osteonics Corp.
• Product Code: KWS · Orthopedic
• Decision Date: Mar 5, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Each Osteonics® Shoulder Humeral Component consists of a humeral stem component and a mating humeral head component. Each device is a single-use device. The Osteonics® Shoulder Humeral Components are intended for cemented or cementless applications. The Osteonics® Shoulder Humeral Components may be used as a hemi- or as a total shoulder replacement device. If used as a hemi-shoulder replacement device, the Osteonics® Shoulder Humeral Components are intended to articulate directly with the anatomic glenoid. If used as a total shoulder replacement device, the Osteonics® Shoulder Humeral Components are intended to articulate with the legally marketed Osteonics® All Polyethylene Glenoid Shoulder Component.

Device Story

Modular shoulder prosthesis consisting of humeral stem and mating humeral head; used for hemi- or total shoulder replacement. Stems manufactured from Ti6Al4V alloy; heads from cobalt chromium alloy (optionally nitrogen ion implanted). Features include male/female taper lock, proximal grit-blasted surface, and distal flats for rotational stability. Implanted by orthopedic surgeons in clinical/OR settings to replace diseased or damaged shoulder joints. Provides structural support and articulation surface to restore joint function, reduce pain, and improve mobility in patients with arthritis, necrosis, or fractures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Ti6Al4V alloy (stem), cobalt chromium alloy (head). Features: Male/female taper lock, grit-blasted proximal stem, distal flats, optional nitrogen ion implantation for bearing surfaces. Modular design for cemented or cementless application.

Indications for Use

Indicated for patients with aseptic necrosis of the humeral head; painful, disabling shoulder joint disease (degenerative, rheumatoid, or post-traumatic arthritis); proximal humeral fracture/dislocation; revision of previous unsuccessful shoulder procedures; or clinical management scenarios where arthrodesis or alternative reconstruction are less likely to achieve satisfactory results.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Osteonics® Shoulder Humeral Components - Osteonics Corp.
• The Global Shoulder - DePuy Inc.
• The Bio-Modular Total Shoulder - Biomet Inc.
• Monospherical Shoulder Prosthesis - Howmedica Inc.

Submission Summary (Full Text)

{0}

K955731

Osteonics® Shoulder Humeral Components

MAR - 5 1996

510(k) Summary

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness
### for the
### Osteonics® Shoulder Humeral Components

## Submission Information

| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
| --- | --- |
| Contact Person: | Terry Jarosz
Regulatory Affairs Specialist |
| Date of Summary Preparation: | February 2, 1996 |

## Device Identification

| Proprietary Name: | Osteonics® Shoulder Humeral Components |
| --- | --- |
| Common Name: | Artificial shoulder humeral component |
| Classification Name and Reference: | Shoulder joint metal/polymer semi-constrained cemented prosthesis
21 CFR §888.3660 |
| | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
21 CFR §888.3690 |

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Osteonics® Shoulder Humeral Components
510(k) Summary

## Predicate Device Identification

The Osteonics® Shoulder Humeral Components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

- The Osteonics® Shoulder Humeral Components - Osteonics Corp.
- The Global Shoulder - DePuy Inc.
- The Bio-Modular Total Shoulder - Biomet Inc.
- Monospherical Shoulder Prosthesis - Howmedica Inc.

## Device Description

Each Osteonics® Shoulder Humeral Component consists of an Osteonics® Shoulder Humeral Stem and a mating Osteonics® Shoulder Humeral Head.

## The Osteonics® Shoulder Humeral Stems:

The Osteonics® Shoulder Humeral Stems are available in a range of sizes, and are manufactured from Ti6Al4V alloy. They are characterized by the following features:

- Male Taper: The humeral stem components are affixed to the modular humeral head components by means of a male/female taper lock.
- Flanges: There are flanges on the anterior, posterior and lateral sides.
- Collar: The collar seats flush with the prepared proximal humerus. There are two collar designs.
- Proximal surface roughening: The surface of the proximal portion of the stem is grit blasted to enhance the cement/prosthesis interface.
- Distal Flats: The distal flats provide rotational stability.

## The Osteonics® Shoulder Humeral Heads:

The Osteonics® Shoulder Humeral Heads feature a female taper design. The heads are available in a range of sizes and thicknesses. The heads feature a circular groove in the non-articulating underside of the component to prevent the components from being unnecessarily heavy. The humeral head components, which are manufactured from cobalt chromium alloy, will be available with or without nitrogen ion implantation.

## Intended Use:

Each Osteonics® Shoulder Humeral Component consists of a humeral stem component and a mating humeral head component. Each device is a single-use device. The Osteonics® Shoulder Humeral Components are intended for cemented or cementless applications.

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Osteonics® Shoulder Humeral Components
510(k) Summary

The Osteonics® Shoulder Humeral Components may be used as a hemi- or as a total shoulder replacement device. If used as a hemi-shoulder replacement device, the Osteonics® Shoulder Humeral Components are intended to articulate directly with the anatomic glenoid. If used as a total shoulder replacement device, the Osteonics® Shoulder Humeral Components are intended to articulate with the legally marketed Osteonics® All Polyethylene Glenoid Shoulder Component.

The specific indications for the use of the Osteonics® Shoulder Humeral Components are as follows:

- Aseptic necrosis of the humeral head.
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

## Statement of Technological Comparison:

The subject devices do not differ in terms of their intended uses from the predicate devices cited earlier in this summary. The subject devices utilize the same materials as one or more of the predicate devices cited above. The subject devices employ design features which are common to one or more of the predicate devices cited above. In addition, the Osteonics® Shoulder Humeral Heads in a version with a nitrogen ion implanted bearing surface can be found substantially equivalent because the use of Nitrogen ion implantation for cobalt chromium bearing surfaces has already been found substantially equivalent by FDA for both hip femoral bearing and knee femoral bearing surfaces.

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