OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES

K012377 · Corin USA · HSD · Mar 11, 2002 · Orthopedic

Device Facts

• Record ID: K012377
• Device Name: OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
• Applicant: Corin USA
• Product Code: HSD · Orthopedic
• Decision Date: Mar 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including: osteoarthritis; rheumatoid arthritis; revision cases where other devices or treatments have failed; correction of functional deformity; treatment of acute fracture of the humeral head unmanageable using other treatment methods; cuff tear arthroplasty. Hemi-resurfacing is also indicated for: humeral head fractures; avascular necrosis of the femoral head.

Device Story

Modular total shoulder replacement system comprising humeral stem, modular head, and glenoid component. Used by orthopedic surgeons in clinical settings to treat degenerative joint disease, fractures, and necrosis. Humeral stem features proximal plasma-sprayed coating for fixation and proximal fin with holes for fracture reconstruction. Device restores joint function and relieves pain through mechanical replacement of damaged shoulder anatomy. Clinical benefit derived from modularity allowing anatomical fit and fixation.

Clinical Evidence

Bench testing only. Testing included static shear testing of the plasma-sprayed surface coating, static tensile testing of the plasma-sprayed surface coating, and microstructure/metallurgy analysis of the surface coating.

Technological Characteristics

Modular shoulder prosthesis. Humeral stem and head: cobalt-chrome (CoCr) alloy. Glenoid component: ultra-high molecular weight polyethylene (UHMWPE). Humeral stem includes proximal plasma-sprayed titanium coating and proximal fin with holes. Dimensions: 120mm and 200mm stem lengths. Non-software device.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, rheumatoid arthritis), cuff tear arthroplasty, functional deformity, humeral head fractures, avascular necrosis of the femoral head, or revision cases requiring shoulder joint replacement or hemi-resurfacing.

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

• Biomet Bio-Modular Shoulder System (K992119)

Submission Summary (Full Text)

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#### KO12377 p/3

## MAR 11 2002

#### 510(k) SUMMARY

#### Device: Oxford Modular Shoulder Prosthesis

Date: 07/17/01

Corin USA Applicant's name: 10500 University Center Drive, Suite 190 Tampa, FL 33612

> Phone: [phone] [phone] Fax:

- Contact person: Joel Batts, Regulatory Affairs Manager
#### Shoulder joint humeral (hemi-shoulder) metallic Classification name: uncemented prosthesis (87HSD)

Shoulder joint metal/polymer semi-constrained cemented prosthesis (87KWS)

C.F.R. section: 21.888.3660, 21.888.3690

Device class: II

Classification panel: Orthopedic

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#### Indications for use

The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:

- osteoarthritis
- rheumatoid arthritis .
- . revision cases where other devices or treatments have failed
- correction of functional deformity ●

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- cuff tear arthroplasty .
Hemi-resurfacing is also indicated for:

- . humeral head fractures
- avascular necrosis of the femoral head ●

#### Device description

The Oxford Modular Shoulder is a modular total shoulder replacement comprised of 3 components: humeral stem, modular head and glenoid.

The humeral stem and head are made from cobalt-chrome alloy; the glenoid component is made from ultra high molecular weight polyethylene (UHMWPE). The humeral stem has a proximal one-third plasma sprayed coating to provide fixation and a proximal fin with holes to allow for reconstruction of fractures.

Substantial equivalence basis

Based on the following SE table, which compares the Oxford Modular Shoulder to the Biomet Bio-Modular Shoulder (K992119), and the risk analysis, the former is believed to be substantially equivalent.

| Features | Oxford<br>Modular<br>Shoulder | Biomet Bio-<br>Modular Shoulder<br>System (K992119) |
|----------------------------------------------------------------|-------------------------------|-----------------------------------------------------|
| Humeral stem substrate | CoCr | Ti6Al4V |
| Indications for use, in<br>the submission, apply | Yes | Yes |
| Proximal plasma<br>sprayed titanium coating<br>on humeral stem | Yes | Yes |
| Lateral fin and finholes<br>on humeral stem | Yes | Yes |
| Collar on humeral stem | No | Yes |
| Humeral stem lengths | 120mm and<br>200mm | 115mm and 190mm |
| CoCr modular heads | Yes | Yes |
| Keeled all-UHMWPE<br>glenoid component | Yes | Yes |
| Glenoid component | 2 sizes, 1 | 3 sizes, 2 |
| sizes | thickness | thicknesses |

K012377

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The guidance document entitled, "Guidance Document For Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Cement" was consulted during the compilation of this submission. Testing that has been performed accordingly includes:

- . static shear testing of the plasma sprayed surface coating
- static tensile testing of the plasma sprayed surface coating ●
- microstructure and metallurgy analysis of surface coating ●

On the basis of the above SE table and the test results provided, this device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 11 2002

Mr. Joel Batts Regulatory Affairs Manager Corin USA 10500 University Center Drive, Suite 190 Tampa, Florida 33612

Re: K012377

Trade/Device Name: Oxford Modular Shoulder Prosthesis Regulation Number: 21 CFR §888.3660; §888.3690 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic cemented or uncemented prosthesis Regulatory Class: Class II

Product Code: KWS; HSD Dated: December 7, 2001 Received: December 11, 2001

Dear Mr. Batts:

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 vour 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.

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## Page 2 - Mr. Joel Batts

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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

Mark M. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012377
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## INDICATIONS FOR USE

The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:

- osteoarthritis .
- rheumatoid arthritis .
- revision cases where other devices or treatments have failed .
- correction of functional deformity .
- treatment of acute fracture of the humeral head unmanageable using other treatment . methods
- cuff tear arthroplasty t

Hemi-resurfacing is also indicated for:

- humeral head fractures ●
- avascular necrosis of the femoral head .

Mark A. Milliken

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012377

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