HERCULON SOFT TISSUE REATTACHMENT SYSTEM

K040594 · United States Surgical, A Division of Tyco Healthc · HWC · Mar 31, 2004 · Orthopedic

Device Facts

• Record ID: K040594
• Device Name: HERCULON SOFT TISSUE REATTACHMENT SYSTEM
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: HWC · Orthopedic
• Decision Date: Mar 31, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Herculon* Soft Tissue Reattachment System is intended for the reapproximation of soft tissue.

Device Story

The Herculon Soft Tissue Reattachment System is a nonabsorbable surgical implant used to attach soft tissue to bone. The device consists of a self-tapping Ti-6Al-4V threaded suture anchor, an inserter, and polyester sutures. It is used by surgeons in clinical settings to facilitate tissue repair in various orthopedic procedures. The anchor is driven into bone, providing a secure point for suture attachment to reapproximate soft tissue. This mechanical fixation aids in healing by holding tissues in place during the recovery process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ti-6Al-4V threaded implant; polyester suture; self-tapping design; materials compliant with ISO 10993-1.

Indications for Use

Indicated for reapproximation of soft tissue in shoulder (Bankart, SLAP, rotator cuff, deltoid, AC separation, capsular shift/reconstruction, biceps tenodesis), elbow (tennis elbow, biceps tendon reattachment), knee (extra-capsular repairs, ligament/capsule reattachment, ITB tenodesis, patellar ligament/tendon avulsions), ankle (lateral/medial instability, Achilles repair/reconstruction), and pelvis (bladder neck suspension).

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

• Ogden* Suture Anchor with Suture (K020352)

Submission Summary (Full Text)

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Attachment 4

MAR 3 1 2004

K040594
pge14/

## 510(k) Summary

#### Herculon* Soft Tissue Reattachment System

United States Surgical 150 Glover Avenue Norwalk, CT 06856 USA

#### DEVICE DESCRIPTION

The Herculon* Soft Tissue Reattachment System is a nonabsorbable repair device used to attach soft tissue to bone using sutures. The device is a self tapping, Ti-6Al-4V threaded implant that accommodates one or two sutures. The sterile package includes a Suture Anchor, Inserter, and polyester suture.

#### CLASSIFICATION NAME

Suture Anchor/Screw, Fixation, Bone

#### INDICATIONS FOR USE

The Herculon* Soft Tissue Reattachment System is indicated for the reapproximation of soft tissue.

#### MATERIALS:

All components of the Herculon* Soft Tissue Reattachment System are comprised of materials which are in accordance with ISO Standard #10993-1.

#### PREDICATE DEVICE

Ogden* Suture Anchor with Suture (K020352)

#### SUBSTANTIAL EQUIVALENCE*

The Herculon* Soft Tissue Reattachment System was claimed to be substantially equivalent* to the currently marketed version of the device. Information pertaining to this device was provided in the submission.

*Any claim of substantial equivalence is made exclusively in regard to the U.S. Food, Drug and Cosmetic Act and should not be viewed in any other light.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAR 3 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chester McCoy Director of Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K040594

Trade/Device Name: Herculon Soft Tissue Reattachment System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 19, 2004 Received: March 8, 2003

Dear Mr. McCoy:

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 - Mr. Chester McCoy

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 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 Milliman

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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# Attachment 2

### Indications for Use Statement

510(k) Number

K040594

Device Name

Herculon* Soft Tissue Reattachment System

Mach N Melleuson
(Division Sign-Off)

510(k) N / *** 3000

Division of General, Restorative, and Neurological Devices

K040594

Indications For Use

The Herculon* Soft Tissue Reattachment System is intended for the reapproximation of soft tissue.

| INDICATION | Procedures |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SHOULDER | Bankart, Slap lesion, Rotator cuff, and Deltoid repair. Acromio-clavicular separation, capsular<br>shift/capsulolabral reconstruction and Biceps tenodesis. |
| ELBOW | Tennis elbow repair, biceps tendon reattachment. |
| KNEE | Extra capsular repairs; reattachment of medial and lateral ligaments, posterior oblique ligament or<br>joint capsule to tibia, and joint capsule closure to anterior proximal tibia; Extra capsular reconstruction, ITB<br>tenodesis, Patellar ligament and tendon avulsions. |
| ANKLE | Lateral and medial instability, Achilles tendon repair/reconstruction. |
| PELVIS | Fixation in pubic bone for the purpose of bladder neck suspension. |

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.109)

OR Over-The-Counter Use: No