HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

K060714 · Conmed Linvatec · HWC · Apr 6, 2006 · Orthopedic

Device Facts

• Record ID: K060714
• Device Name: HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
• Applicant: Conmed Linvatec
• Product Code: HWC · Orthopedic
• Decision Date: Apr 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conmed Linvatec Hi-Fi™ 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 lessons, SLAP lesions, capsular shifts, capsulolabral reconstructions.

Device Story

Sterile, single-use, metal suture anchor; preloaded with high-strength, non-absorbable, braided ultra-high molecular weight polyethylene suture. Used by surgeons in clinical settings for soft tissue-to-bone fixation in shoulder procedures. Implanted into glenoid bone to secure soft tissue; knotless design facilitates fixation. Provides mechanical reattachment of tissue to bone to support healing in patients with shoulder lesions or instability.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Implant manufactured from 316LS Stainless Steel per ASTM F-138 and ISO 832-1. Preloaded with non-absorbable, braided, ultra-high molecular weight polyethylene suture. Sterile, single-use, knotless mechanical fixation device.

Indications for Use

Indicated for reattaching soft tissue to glenoid bone in the shoulder for patients requiring repair of Bankart lesions, SLAP lesions, capsular shifts, or 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.

Predicate Devices

• Ultrafix Knotless Minimite Suture Anchor (K022827)

Submission Summary (Full Text)

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Ko60714 Pge 1/2

## 6 2006 APR

March 1, 2006

# SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMedLinvatec is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the Hi-Fi UltraFix Knotless Minimite Suture Anchor.

#### Submitter A.

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

#### B. Company Contact

Elizabeth Paul Manager, Regulatory Affairs [phone] Telephone [phone]FAX

#### C. Device Name

| Trade Name: | Hi-Fi UltraFix Knotless Minimite Suture Anchor |
|------------------------|--------------------------------------------------------------|
| Common Name: | Soft tissue fixation suture anchor |
| Classification Names: | 888.3040 - Fastener, Fixation, Nondegradable, Soft<br>Tissue |
| Proposed Class/Device: | Class II |
| Product Code: | MBI |

### Predicate/Legally Marketed Devices D.

K022827 -- Ultrafix Knotless Minimite Suture Anchor

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Page 242

Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor Special 510(k) # _____________________________________________________________________________________________________________________________________________________________ March 1, 2006

#### E. Device Description

The Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is a sterile, single-use, metal implant that is preloaded with high strength size 2 non-absorbable braided polyethylene suture.

The implanted anchor is manufactured from 316LS Stainless Steel, per ASTMF-138, ISO 832-1 and is preloaded with a non-absorbable, braided, ultra-high molecular weight, polyethylene suture.

## Intended Use

The Conmed Linvatec Hi-Fi™ 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 lessons, SLAP lesions, capsular shifts, capsulolabral reconstructions.

#### F. Substantial Equivalence

Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is substantially equivalent in indication for use, scientific technology and design to the UltraFix@ Knotless Minimite® Suture Anchor. The UltraFix® Knotless Minimite® Suture Anchor was cleared by FDA under 510(k) K022827. The changes made to the predicate device have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2006 APR

ComMed Linvatec c/o Ms. Elizabeth Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K060714

Trade/Device Name: Hi-Fi™ 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: HWC, MBI Dated: March 1, 2006 Received: March 17, 2006

Dear Ms. Paul:

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. Iisting 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. Elizabeth Paul

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/industry/support/index.html.

Sincerely yours,

J. Vicker Lemon (3)

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko 60714

Device Name: Hi-Fi™ UltraFix® Knotless Mirrimite® Suture Anchor

Indications for Use:

The Conmed Linvatec Hi-Fi™ 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 lesions, SLAP lesions, capsular shifts, capsulolabral reconstructions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUF: ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Levice Evaluation (ODE)

OR Prescription Use __X (Per 21 CFR 801.109)

Over-the-Counter Use _No

Hulur Semedix

Division of General, Restorates and Neurological Devices

**510(k) Number** k0160714