MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS

K040128 · Howmedica Osteonics Corp. · HSD · Mar 26, 2004 · Orthopedic

Device Facts

• Record ID: K040128
• Device Name: MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSD · Orthopedic
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.

Device Story

Modular Replacement System (MRS) Humeral Stems are orthopedic implants designed for proximal humerus reconstruction following tumor resection. The device is a non-porous coated humeral stem used in conjunction with other MRS components and bone cement. This submission introduces an alternate cobalt-chromium alloy material with different metallurgical properties compared to previous versions, while maintaining the same design and intended use. The device is intended for surgical implantation by orthopedic surgeons in a clinical/hospital setting to restore skeletal structure in patients with significant bone loss.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-porous coated humeral stem fabricated from cobalt-chromium alloy conforming to ASTM F-1537. Designed for use with bone cement. Metallic uncemented prosthesis classification (21 CFR 888.3690).

Indications for Use

Indicated for patients requiring proximal humerus reconstruction due to extensive bone loss from tumor resection (primary or metastatic skeletal lesions). Intended for use with bone cement.

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

• MRS Humeral Stems (K954559)
• MRS Humeral Stems (K032264)

Submission Summary (Full Text)

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MAR 2 6 2004

Modular Replacement System Humeral Stems - Alternate Material

K040128

Special 510(k) Premarket Notification

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## Special 510(k) Summary

| Proprietary Name: | Modular Replacement System (MRS) Humeral Stems |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Modular Humeral Stems |
| Classification Name and Reference: | Prosthesis, shoulder, hemi-, humeral, metallic uncemented<br>21 CFR §888.3690 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 HSD |
| Predicate Proprietary Name: | MRS Humeral Stems |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | 87 HSD |
| For Information contact: | Margaret F. Crowe<br>Howmedica Osteonics Corp.<br>DBA Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, New Jersey 07430<br>Phone: [phone]<br>Fax: [phone] |

### Description/Technological Comparison

Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded this product line to include non-porous coated humeral stems. Both of these stems are fabricated from cobaltchromium alloy that conforms to ASTM F-1537. It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has

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Special 510(k) Prem

slightly different metallurgical properties.

### Intended Use

The intended usc of the subject device is not changed by this material change: The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humcrus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K040128

> Trade/Device Name: Modular Replacement System Humeral Stems - Alternate Material Regulation Number: 21 CFR 888.3690 Regulatory Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: March 4, 2004 Received: March 8, 2004

Dear Ms. Crowe:

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

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### Page 2 - Margaret F. Crowe

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), 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.

b. Mark N. Millman

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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## Special 510(k) Premarket Notification- Modular Replacement System Humeral Stems -Alternate Material

## 510(k) Number (if known): K. NUI l 27

Device: Modular Replacement System Humeral Stems - Alternate Material

The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (/ OR Over-the Counter-Use (per 21 CFR 801.109)

Mark N. Millman

al. Restorative, Division of Gene and Neurological Devices

**510(k) Number** K040128

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