MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM

K032264 · Howmedica Osteonics Corp. · HSD · Aug 8, 2003 · Orthopedic

Device Facts

• Record ID: K032264
• Device Name: MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSD · Orthopedic
• Decision Date: Aug 8, 2003
• 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.

Device Story

Modular Replacement System (MRS) Humeral Stems are orthopedic implants used for proximal humerus reconstruction following tumor resection. Subject device is a line extension of existing MRS Humeral Stems, differing by the absence of a porous coated body segment. Device is intended for use with bone cement. Stems are available in the same diameters and lengths as the predicate porous-coated versions. Used by surgeons in clinical settings to restore skeletal structure in patients with primary or metastatic bone lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic humeral prosthesis; uncemented design (intended for use with bone cement); line extension of existing MRS Humeral Stems; lacks porous coating present on predicate.

Indications for Use

Indicated for patients requiring reconstruction of the proximal humerus due to extensive bone loss resulting from tumor resection secondary to primary or metastatic skeletal lesions.

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)

Submission Summary (Full Text)

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K032264

| | Line Extension to the Modular Replacement System Humeral Stems | | Special 510(k) Premarket Notification |
|--|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| | | AUG - 8 2003 | |
| | | Special 510(k) Summary | |
| | Proprietary Name: | Modular Replacement System (MRS) Humeral<br>Stems | |
| | Common Name: | Modular Humeral Stems | |
| | Classification Name and Reference: | Prosthesis, shoulder, hemi-, humeral, metallic<br>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>59 Route 17<br>Allendale, New Jersey 07401-1677<br>Phone: [phone]<br>Fax: [phone] | |

## Description/Technological Comparison

The predicate MRS Humeral Stems had a porous coated body (or seat) segment. The subject MRS Humeral Stems do not have a porous coated body segment. The subject stems are offered in the same diameters, and the same lengths as the previously released porous coated humeral stems.

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K032264

## 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.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers. The symbol is composed of thick, curved lines, giving it a modern and minimalist appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K032264

Trade/Device Name: Modular Replacement System (MRS) Humeral Stem Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: July 22, 2003 Received: July 23, 2003

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 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 - Ms. Margaret F. Crowe

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,

Miriam C. Provost

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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K032264

Special 510(k) Premarket Notification-Line Extension to MRS Humeral Stems

510(k) Number (if known): K

Line Extension to MRS Humeral Stems -- MRS Humeral Stems without Device: Porous Coated Body

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-the Counter-Use 801.109)

Miriam C. Provost

torative

510(k) Number K032264