OTI MODULAR SHOULDER SYSTEM

K982886 · Osteoimplant Technology, Inc. · HSD · Oct 5, 1998 · Orthopedic

Device Facts

• Record ID: K982886
• Device Name: OTI MODULAR SHOULDER SYSTEM
• Applicant: Osteoimplant Technology, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component)may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.

Device Story

OTI Modular Shoulder System is a hemi-humeral prosthetic implant; used for shoulder joint replacement; intended to alleviate pain and restore function in patients with degenerative, rheumatoid, or traumatic conditions; device replaces damaged humeral head; surgical implantation performed by orthopedic surgeons in hospital setting; provides structural support and joint articulation; benefits patient by improving mobility and reducing pain associated with joint disease or trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular hemi-humeral shoulder prosthesis; metallic construction; designed for surgical implantation; standard orthopedic implant form factor.

Indications for Use

Indicated for patients requiring prosthetic shoulder replacement due to severe pain or disability from degenerative, rheumatoid, or traumatic shoulder joint disease, humeral head fracture non-union, avascular necrosis, or traumatic humeral fractures.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1998

Mr. Sam Son Vice President of Technical Affairs Osteoimplant Technology, Inc. 11201 Pepper Road Hunt Valley, Maryland 21031

Re: K982886 OTI Modular Shoulder System Regulatory Class: II Product Code: HSD Dated: August 12, 1998 Received: August 17, 1998

Dear Mr. Son:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Sam Son

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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## 510(k) Number (if known): 510(k) K 982886 Device Name: OTI Modular Shoulder System

Indications For Use:

Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component)may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

D. Seela

OR

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982886

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)