OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM

K990712 · Howmedica Osteonics Corp. · MJT · Jul 20, 1999 · OR

Device Facts

• Record ID: K990712
• Device Name: OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MJT · OR
• Decision Date: Jul 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The indications for the Osteonics Solar™ Shoulder Bipolar System are: - 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 - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. - Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

Device Story

The Osteonics Solar Shoulder Bipolar System is a modular shoulder prosthesis for hemi-shoulder replacement. It consists of a humeral stem, a bipolar humeral head component (metal shell, UHMWPE insert, locking ring), and a 22 mm bipolar modular head. The device is intended for cementless application, articulating directly with the anatomic glenoid. It is a single-use, sterile device used by orthopedic surgeons in a clinical/surgical setting to treat shoulder joint disease or fractures. The system provides a mechanical replacement for the humeral head to restore joint function and reduce pain. The device is designed to be used with other components of the Osteonics Solar Shoulder System.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: ASTM F75 cobalt chromium alloy (shell), ASTM F1537 cobalt chromium alloy (modular head), and UHMWPE (insert). Design: Modular bipolar humeral head system for cementless use. Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for patients with aseptic necrosis of the humeral head, painful/disabling degenerative, rheumatoid, or post-traumatic arthritis of the shoulder, proximal humeral fracture/dislocation, or conditions requiring conservative glenoid procedures avoiding bone cement.

Predicate Devices

• Biomet Bi-Angular Bi-Polar Shoulder System

Submission Summary (Full Text)

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JUL 20 1999

Osteonics" Solar256 Shoulder Bipolar System

# 712

510(k) Summary

# 510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics Solar™ Shoulder Bipolar System

### 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: | Karen Ariemma<br>Regulatory Affairs Specialist |
| Date of Summary Preparation: | April 1, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Solar™ Shoulder Bipolar<br>System |
| Common Name: | Bi-Polar Shoulder Components |
| Classification Name and Reference: | Shoulder joint metal/polymer<br>Semi-constrained cemented<br>prosthesis<br>21 CFR §888.3660<br><br>Shoulder joint humeral (hemi-<br>shoulder) metallic uncemented<br>prosthesis<br>21 CFR §888.3690 |

# Predicate Device Identification

The Osteonics" Solar™ Shoulder Bipolar components are substantially equivalent to the following competitive device, which have previously been determined substantially equivalent by FDA:

- Biomet Bi-Angular Bi-Polar Shoulder System .

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K990712

Osteonics" Solar 14 Shoulder Bipolar System

510(k) Summary

#### Device Description

The Osteonics" Solar™ Shoulder Bipolar System consists of an Osteonics Solar™ Shoulder Bipolar Humeral Head Component, an Osteonics 22 mm Solar™ Shoulder Bipolar Modular Head and an Osteonics Solar™ Shoulder Humeral Stem. The humeral stem was determined substantially equivalent via 510(k) K955731. There have been no modifications made to the humeral stem. The bipolar head component consists of three preassembled pieces: a metal shell, UHMWPE insert and locking ring. The component will be sold preassembled. The metallic shell is manufactured from ASTM F75 cobalt chromium alloy. The 22 mm bipolar modular head is manufactured from ASTM 1537 cobalt chromium alloy. The Osteonics Solar™ cobalt chromium Shoulder Bipolar Components (Bipolar Head Component and 22 mm Bipolar Modular Head) are intended to be used in cementless applications and as a hemi-shoulder system. Used as a hemi-shoulder replacement device, the Osteonics Solar™ Shoulder, Bipolar Humeral Head Components are intended to articulate directly with the anatomic glenoid.

## Intended Use:

Indications:

The indications for the Osteonics Solar™ Shoulder Bipolar System are:

- 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
- Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

# Statement of Technological Comparison:

The subject devices (Bipolar Humeral Head and Bipolar Modular Head) are substantially equivalent to the bipolar components (Bi-Polar Shell and Bi-

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K990712

#### Osteonics" Solar TM Shoulder Bipolar System

#### 510(k) Summary

Angular/Bi-Polar Modular Heads) of the predicate Biomet Bi-Angular Bi-Polar Shoulder System Components in all material and design aspects, indications, and intended use.

## Summary

Based on the information presented above, the substantial equivalence of the Osteonics Solar™ Shoulder Bipolar Component to other legally marketed, class III bipolar shoulder components is demonstrated.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 - 1999

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

к990712 Re: K990712
Trade Name: Osteonics® Solar™ Shoulder Bipolar System Regulatory Class: III Product Code: MJT Dated: March 3, 1999 Received: March 4, 1999

Dear Ms. Ariemma:

We have reviewed your Section 510(k) notification of intent to we have leviewed your boosed. Ove and we have determined the market the device is ly equivalent (for the indications for device is substancially cyca) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce prior amendments, or to devices that have been Medical Devrec Amendison, with the provisions of the Federal You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. of the nec. The goss 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. ਜਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sist. Prour device 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 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 Also, please note the Office of Compliance at [phone]. 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

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): K990712

# Device Name: Osteonics® Solar™ Shoulder Bipolar System

The subject components of the Osteonics Solar™ Shoulder Bipolar System are single-use devices which are sold sterile and are intended for use with only the other components of the commercially available Osteonics Solar™ Shoulder System.

The indications for the Osteonics Solar™ Shoulder Bipolar System components, in keeping with those of other legally devices 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 �
- Clinical management problems where arthrodesis or alternative techniques are less likely to . achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative glenoid procedure and � avoidance of the use of bone cement in the glenoid.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Deedee