REUNION HA FRACTURE STEM

K070963 · Howmedica Osteonics Corp. · HSD · May 4, 2007 · Orthopedic

Device Facts

• Record ID: K070963
• Device Name: REUNION HA FRACTURE STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSD · Orthopedic
• Decision Date: May 4, 2007
• 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 humerus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.

Device Story

ReUnion™ HA Fracture Stem is a metallic humeral component for shoulder arthroplasty. It functions as a structural implant for proximal humerus reconstruction in primary or revision shoulder joint replacement. The device is a line extension of the Solar® ReUnion™ Fracture Stem, modified to exclude CP Ti plasma spray. It is intended for surgical implantation by orthopedic surgeons in a hospital setting. The device provides mechanical support and joint articulation, replacing diseased or fractured bone to restore shoulder function and reduce pain. It is a single-use, sterile implant.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on engineering analysis and design comparison to the predicate device.

Technological Characteristics

Metallic humeral prosthesis; uncemented design. Materials and design are consistent with the predicate Solar® ReUnion™ Fracture Stem, excluding the CP Ti plasma spray coating. Device is provided sterile for single use.

Indications for Use

Indicated for patients requiring bipolar or total shoulder replacement due to aseptic necrosis of the humeral head, painful/disabling degenerative, rheumatoid, or post-traumatic arthritis, proximal humeral fractures/dislocation, or clinical management problems where alternative reconstructive techniques are less likely to achieve satisfactory results. Bipolar use also indicated for conditions requiring conservative glenoid procedures or avoidance of bone cement. Total shoulder use also indicated for revision of previous unsuccessful procedures.

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® ReUnion™ Fracture Stem

Submission Summary (Full Text)

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+ 4 2007

K570963

MAY - 4 2007

# Summary of Safety and Effectiveness ReUnion™ HA Fracture Stem

| Proprietary Name: | ReUnion™ HA Fracture Stem |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Shoulder Prosthesis |
| Classification Name and Reference: | Shoulder joint metal/polymer semi<br>constrained cemented prosthesis. 21 CFR<br>§888.3660 |
| | Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis. 21 CFR<br>§888.3690 |
| Device Product Code: | 87 KWS, 87 HSD |
| For Information Contact: | Francisco Haro, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | April 3, 2007 |

## Description:

This submission is a line extension to the Solar® ReUnion™ Fracture Stem for fracture humeral stem with no CP Ti plasma spray. Fracture humeral stems will be based on the Solar® ReUnion™ Fracture Stem.

#### 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 humerus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.

#### Indications for Use:

### For use as a Bipolar Shoulder Replacement:

- . Aseptic necrosis of the humeral head

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K070963

- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- . Clinical management problems where arthodesis 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 fractures and/or dislocation.
- Clinical management problems where arthodesis 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 ReUnion™ HA Fracture Stem is substantially equivalent to the Solar® ReUnion™ Fracture Stem in regards to intended use, design, materials, and operational principles as humeral components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2007

Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K070963

Trade/Device Name: ReUnion™ HA Fracture Stem Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: April 3, 2007 Received: April 5, 2007

Dear Mr. Haro:

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.

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Page 2 - Mr. Francisco Haro

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 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/dsma/dsmamain.html

Sincerely yours,

Валеше Вuekup

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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510(k) Number (if known):

Device Name: ReUnion™ HA Fracture Stem

Indications for Use:

# 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 fractures and/or dislocation.
- Clinical management problems where arthodesis 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 fractures and/or dislocation.
- Clinical management problems where arthodesis 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 Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off Division of General, Restorative. and Neurological Devices

**510(k) Number** k070963

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