ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

K022827 · Linvatec Corp. · MBI · Nov 22, 2002 · Orthopedic

Device Facts

• Record ID: K022827
• Device Name: ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
• Applicant: Linvatec Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Linvatec UltraFix® Knotless MiniMite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions.

Device Story

UltraFix Knotless MiniMite Suture Anchor is a mechanical bone fixation device; used for reattaching soft tissue to glenoid bone in shoulder. Device functions as a fastener to secure tissue during orthopedic procedures such as Bankart lesion repair, SLAP lesion repair, capsular shift, and capsulolabral reconstructions. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical fixation to facilitate healing of soft tissue to bone.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use characteristics.

Technological Characteristics

Mechanical bone fixation fastener; nondegradable material; intended for soft tissue to bone fixation. Dimensions and specific material standards not detailed in provided text.

Indications for Use

Indicated for patients requiring soft tissue to glenoid bone reattachment in the shoulder, specifically for Bankart lesion repairs, SLAP lesion repairs, capsular shift, and capsulolabral reconstructions.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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August 22, 2002

# SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 22 2002

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the UltraFix® Knotless MiniMite® Suture Anchor 510(k) Number Ko222827.

#### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### B. Company Contact

Laura D. Seneff, RAC Manager, Regulatory Affairs [phone] Telephone [phone] FAX

### C. Device Name

Trade Name: UltraFix® Knotless MiniMite® Suture Anchor

Common Name: Bone Anchor

Classification Names: Fastener, fixation, nondegradable, soft tissue

Proposed Class/Device: Class II Product Code MBI

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K022827

Trade/Device Name: UltraFix® Knotless MiniMite® Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 22, 2002 Received: August 26, 2002

Dear Ms. Seneff:

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. Laura D. Seneff

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]. 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 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,

Mark N Milken

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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August 22, 2002

510(k) Number (if known):

Device Name: UltraFix® Knotless MiniMite® Suture Anchor

Indications for Use:

The Linvatec UltraFix® Knotless MiniMite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

for Mark N Milkum
(Division Sign-Off)

Division of General, Restorative and Neurological De

510(k) Number .