OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD

K990598 · Howmedica Osteonics Corp. · KWS · Mar 15, 1999 · Orthopedic

Device Facts

• Record ID: K990598
• Device Name: OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWS · Orthopedic
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the modified humeral bearing heads is identical to that of the unmodified humeral bearing heads. As with the predicate humeral bearing heads, the modified humeral bearing heads are single use devices. They are intended for mating with the Osteonics® Solar Humeral Stems. The Osteonics® Solar Humeral Components are designed to be used in either cemented or cementless applications, as either a hemi-shoulder or a total shoulder component. For use as a total shoulder replacement, the modified and predicate humeral bearing heads may be used in conjunction with any legally marketed Osteonics glenoid component. The indications for the Osteonics® Solar Shoulder Components include: - 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.

Device Story

Osteonics® Solar Shoulder Humeral Bearing Head is a prosthetic component for shoulder arthroplasty; used as hemi-shoulder or total shoulder replacement; mates with Osteonics® Solar Humeral Stems; compatible with legally marketed Osteonics glenoid components. Device modification involves transition from wrought ASTM F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy; includes minor dimensional changes (draft angles 0.5 to 1.5 degrees) to facilitate casting mold removal. Intended for single use; implanted by orthopedic surgeons in clinical/hospital settings. Provides structural replacement for humeral head to restore joint function and reduce pain in patients with degenerative or traumatic shoulder conditions.

Clinical Evidence

Bench testing only. Engineering analyses performed to demonstrate that mechanical properties of the cast cobalt chromium alloy are within acceptable limits for the device.

Technological Characteristics

Material: Cast ASTM F-75 cobalt chromium alloy (replacing wrought ASTM F-1537). Design: Humeral bearing head with 0.5 to 1.5-degree draft angles on internal walls for casting. Energy source: None (passive implant). Connectivity: None. Sterilization: Not specified.

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 unsuccessful total shoulder replacement/resurfacing; or clinical management cases 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® Solar Shoulder Humeral Bearing Head (K955731)

Submission Summary (Full Text)

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3/15/99

K990598

# Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® Solar Shoulder Humeral Bearing Head

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marybeth Naughton<br>Regulatory Affairs Team Member |
| Date of Summary Preparation: | February 23, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Solar Shoulder Humeral<br>Bearing Head |
| Common Name: | Shoulder Prosthesis |
| Classification Name and Reference: | Shoulder joint humeral (hemi-shoulder)<br>Metallic uncemented prosthesis<br>21 CFR §888.3690<br>Or<br>Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis<br>21 CFR §888.3660 |

# Predicate Device Identification

The modified features of the Osteonics® Solar Shoulder Humeral Bearing Heads are substantially equivalent to features of the following Osteonics® predicate devices, which have been cleared for marketing via the 510(k) process:

- · Osteonics® Solar Shoulder Humeral Bearing Head (#K955731)
#### Device Description

The Osteonics® Solar Shoulder Humeral Bearing Heads are currently marketed devices that are being modified. The modification to the device involves a manufacturing process change in

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manufacturing of the humeral bearing head from wrought ASTM (American Society for Testing and Materials) F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy. Howmedica Osteonics intends to replace the current line of wrought cobalt chromium alloy humeral bearing heads with the subject cast cobalt chromium alloy humeral bearing heads. Minor dimensional changes will accompany the manufacturing process change. When changing from a machining process to a casting process. certain design features (dimensional) must be added to the cast part that is not necessary to the machined part when being manufactured. The internal geometry of the cast part requires draft angles to be placed on all walls of the device that are parallel to the parting line to facilitate the removal of the part from the casting mold. These angles range from approximately 0.5 degrees to 1.5 degrees per side.

## Intended Use:

The intended use of the modified humeral bearing heads is identical to that of the unmodified humeral bearing heads. As with the predicate humeral bearing heads, the modified humeral bearing heads are single use devices. They are intended for mating with the Osteonics® Solar Humeral Stems. The Osteonics® Solar Humeral Components are designed to be used in either cemented or cementless applications, as either a hemi-shoulder or a total shoulder component. For use as a total shoulder replacement, the modified and predicate humeral bearing heads may be used in conjunction with any legally marketed Osteonics glenoid component. The indications for the Osteonics® Solar Shoulder Components include:

- 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.

## Performance Data:

Engineering Analyses have been performed to demonstrate that mechanical properties of the cast cobalt chromium alloy to be well within the acceptable limits for the subject device.

## Statement of Technological Comparison:

- All features of the Osteonics® Solar Shoulder Humeral Bearing Head are unchanged with the exception of 1) the change in materials from wrought ASTM F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy and 2)minor dimensional changes required for the casting procedure.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Ms. Elizabeth A. Staub Vice President, Quality Assurance/Regulatory Compliance/Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K990598 Re: Osteonics® Solar Shoulder Humeral Bearing Head Regulatory Class: III Product Codes: KWS and HSD Dated: February 23, 1999 February 24, 1999 Received:

Dear Ms. Staub:

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 able beated in the enoices, 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 aqainst 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 Requlations, 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 (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. 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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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 requlation (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.qov/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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#### Page 1 of 1

# 510(k) Number (if known): KY90598

Device Name: Osteonics® Solar Shoulder Humeral Bearing Head

Indications For Use:

The indications for the use of the Osteonics® Solar Shoulder Humeral Bearing Head , in keeping with those of other legally marketed Osteonics® shoulder components, are as follows:

#### Indications

- 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use*_*_

(Optional Format 1-2-96)

Aisellifo
(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K990898