SUPER REVO HERCULINE SUTURE ANCHOR

K041713 · Linvatec Corp. · MBI · Jul 22, 2004 · Orthopedic

Device Facts

• Record ID: K041713
• Device Name: SUPER REVO HERCULINE SUTURE ANCHOR
• Applicant: Linvatec Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Super Revo® Herculine™ Suture Anchor is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

Device Story

Titanium suture anchor implant; pre-threaded with nonabsorbable, braided, ultra-high molecular weight polyethylene (UHMWPE) suture (white or white/blue stripe). Provided preloaded on disposable driver with stainless steel shaft and ABS handle. Used by surgeons in OR for rotator cuff repair; arthroscopic or mini-open approach. Device provides mechanical fixation of soft tissue to bone. Single-use, sterile.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium suture anchor; UHMWPE braided suture; stainless steel driver shaft; ABS handle. Sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for rotator cuff repairs in the shoulder, performed via arthroscopic or mini-open surgical techniques.

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

• Super Revo® Suture Anchor (K003984)

Reference Devices

• TeleFlex Medical suture (K033654)
• TeleFlex Medical suture (K040472)

Submission Summary (Full Text)

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# JUL 22 2004

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## PROPRIETARY INFORMATION - LINVATEC CORPORATION

June 14, 2004

### SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of In accordance that 92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the Super Revo® Herculine™ Suture Anchor 510(k) Number KO41713

#### Submitter A.

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

#### Company Contact B.

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

#### C. Device Name

Super Revo® Herculine™ Suture Anchor Trade Name:

Suture Anchor Common Name:

Fixation, Nondegradable, Soft Classification Names: Fastener, Tissue, 21 CFR 888.3040

Proposed Class/Device: Class II

MBI Product Code:

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K041713 Page 2/3

### PROPRIETARY INFORMATION - LINVATEC CORPORATION

Summary of Safety and Effectiveness SuperRevo® Herculine™ Suture Anchor 510(k) # KO417(3 June 14, 2004

#### Predicate/Legally Marketed Devices D.

Super Revo® Suture Anchor Linvatec Corporation

510(k) # K003984

#### Device Description ui

The Super Revo® Herculine™ Suture Anchor is a titanium suture anchor implant pre-threaded with undyed (white) and colored (white with blue stripe), nonabsorbable, braided, ultra-high molecular weight, polyethylene suture. It is provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. The Super Revo® Herculine™ Suture Anchor is supplied sterile and single use.

The modification described in this Special 510(K) is to supply the Super Revo® suture anchor with the ultra-high molecular weight polyethylene suture.

This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

#### F. Intended Use

The Super Revo® Herculine™ Suture Anchor is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

#### Substantial Equivalence G.

The Super Revo® Herculine™ Suture Anchor is substantially equivalent in intended use, scientific technology and design to the Super Revo® Suture Anchor. Testing has been conducted to assure

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K041713 page 3/3

### PROPRIETARY INFORMATION - LINVATEC CORPORATION

that providing the suture anchor with the ultra-high molecular weight, braided, polyethylene suture does not raise any new issues regarding safety and effectiveness.

TeleFlex Medical, Fall River, MA supplies the suture which is approved for commercial distribution in the U.S. under 510(k) numbers K033654 (white) and K040472 (colored) .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2004

Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corp. 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K041713

R041713
Trade/Device Name: Super Revo® Herculine™ Supers Anchor Regulation Number: 21 CFR 888.3040, 21 CFR 878.5000 Regulation Name: Non-degradable soft tissue fastener; Polyethylene suture Regulatory Class: II Product Code: MBI, GAT Dated: June 14, 2004 Received: June 23, 2004

Dear Ms. Paul:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector b 1 (x) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Free (110) and the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general obtarely proficturing 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 11 your device 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 I 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 sct 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) I mis letter will and in your e FDA finding of substantial equivalence of your device to a legally premits to hoticate 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 If you deeme specific as 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 vours,

Sincerely yours,

Mark N Melkerson

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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# Indications for Use

510(k) Number (if known): K041713

Device Name: Super Revo® Herculine™ Suture Anchor

Indications For Use: The Super Revo® Herculine™ Suture Anchor is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millken

Division of General, Restorative, and Nourclegical Devices

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510(k) Number K091713