SOLAR PUREFIX HA SHOULDER

K061677 · Howmedica Osteonics Corp. · HSD · Jul 10, 2006 · Orthopedic

Device Facts

• Record ID: K061677
• Device Name: SOLAR PUREFIX HA SHOULDER
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSD · Orthopedic
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal himmorus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.

Device Story

Solar® PureFix® HA Shoulder is a proximal humeral stem for shoulder arthroplasty. Device is manufactured from titanium alloy with a proximal coating of commercially pure titanium (CP-Ti) and hydroxyapatite. It features a taper compatible with existing Howmedica Osteonics humeral head lines. Available in 11 sizes (7mm to 17mm distal diameters). Used by orthopedic surgeons in clinical settings for primary or revision shoulder reconstruction. Device provides structural support for the proximal humerus; hydroxyapatite coating promotes biological fixation. Output is a mechanical implant; clinical benefit includes pain relief and restoration of joint function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Proximal humeral stem; titanium alloy substrate; proximal coating of commercially pure titanium (CP-Ti) and hydroxyapatite. 11 sizes (7mm-17mm diameters). Tapered design for humeral head compatibility. Sterile, single-use device.

Indications for Use

Indicated for patients requiring bipolar or total shoulder replacement due to aseptic necrosis of the humeral head, painful/disabling joint disease (degenerative, rheumatoid, or post-traumatic arthritis), proximal humeral fracture/dislocation, or clinical management problems where alternative techniques are less likely to succeed. Also indicated for revision of previous unsuccessful total shoulder replacement or resurfacing. Bipolar use includes cases requiring conservative glenoid procedures or avoidance of bone cement in the glenoid.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• Solar® Shoulder (K955731)

Submission Summary (Full Text)

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# JUL 1 0 2006

K06)677 (m 1042

Image /page/0/Picture/2 description: The image shows the logos of Stryker Howmedica and OSTEONICS. The Stryker logo is in a smaller font size and is placed above the Howmedica logo. The OSTEONICS logo is placed below the Howmedica logo and is underlined. All the logos are in black color.

325 Corporate Drive
Mahwah, NJ USA 07430

## 510(k) Summary of Safety and Effectiveness for the Solar® PureFix® HA Shoulder

| Proprietary Name: | Solar® PureFix® HA Shoulder Humeral<br>Stem |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Shoulder Prosthesis |
| Classification Name and Reference | Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis<br>21 CFR §888.3690 |
| | Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis<br>21 CFR §888.3660 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 HSD - prosthesis, shoulder, hemi-,<br>humeral, metallic uncemented, |
| | 87 KWS - prosthesis, shoulder, semi-<br>constrained, metal/polymer cemented |
| For Information contact: | Tiffani Rogers<br>Regulatory Affairs Specialist<br>Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, New Jersey 07430<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Summary Prepared: | June 13, 2006 |

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K06 1677 (pg 2 of 2)

### Device Description

The Solar® PureFix® HA Shoulder is a proximal humeral stem manufactured from titanium alloy. The proximal section of the stem is coated with commercially pure titanium (CP-Ti) and hydroxyapatite. The Solar® PureFix® HA Shoulder is available in 11 sizes with distal diameters ranging from 7mm to 17mm in 1mm increer es without Solar® PureFix® HA Shoulder features a taper that is compatible with the Salar® Shoulder lines of humeral heads currently marketed by Howmedica Osteonics.

### Intended Use:

The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal himmorus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.

### Indications:

For use as a Bipolar Shoulder Replacement:

- 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.

For use as a Total Shoulder Replacement:

- 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.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.

### Substantial Equivalence:

The determination of the substantial equivalence of the Solar® PureFix® HA Shoulder is based on its similarities in indications for use, intended use, design and sterilization to the Solar® Shoulder (K955731, cleared March 05, 1996).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2006

Howmedica Osteonics Corp. c/o Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K061677

Trade/Device Name: Solar® PureFix® HA Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD, KWS Dated: June 13, 2006 Received: June 19, 2006

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 – Ms. Tiffani Rogers

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), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Qalbage Bnech MD

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K661677

### Indications for Use

510(k) Number (if known):

Device Name: Solar® PureFix® HA Shoulder

#### Indications

For use as a Bipolar Shoulder Replacement:

- 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.

#### For use as a Total Shoulder Replacement:

- . 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.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.

| Prescription Use | X |
|------------------|---|
|------------------|---|

OR Over-the-Counter Use (Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| <i>Jenbere meehn</i> | |
|------------------------------------------------------------|----------------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | <i>K061677</i> |

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