SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE

K052652 · Smith & Nephew, Inc. · GAT · Oct 21, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052652
• Device Name: SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
• Applicant: Smith & Nephew, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.

Device Story

The Smith & Nephew Continuous Loop Fixation Device is a pre-measured polyester suture loop designed for orthopedic surgery. It functions as a fixation device for tendons and ligaments during ACL or PCL reconstruction. By providing pre-measured lengths, the device eliminates the need for manual knot tying during the procedure. It is intended for use by orthopedic surgeons in a clinical or operating room setting. The device simplifies the fixation process, potentially reducing operative time and improving consistency in graft tensioning compared to traditional suturing techniques.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Polyester suture material; continuous loop configuration; available in 20, 40, and 60 mm lengths. Mechanical fixation principle. Non-absorbable.

Indications for Use

Indicated for fixation of tendons and ligaments during orthopedic reconstruction procedures, specifically ACL or PCL reconstruction.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Smith & Nephew Endobutton CL (K980155)

Submission Summary (Full Text)

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K052652,1/2

# OCT 2 1 2005

## SECTION V

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

## Smith & Nephew Continuous Loop Fixation Device

Date Prepared: September 23, 2005

## A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810

## B. Company Contact

Deana Boushell Principle Regulatory Affairs Specialist [phone] Phone: [phone] FAX:

## C. Device Name

| Trade Name: | Smith & Nephew Continuous Loop Fixation Device |
|----------------------|------------------------------------------------|
| Common Name: | Suture Loop |
| Classification Name: | Nonabsorbable polypropylene surgical suture |

#### Predicate Devices D.

The Smith & Nephew Continuous loop is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew Endobutton CL (K980155).

## E. Description of Device

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The Smith & Nephew Continuous Loop Fixation Device is a suture loop manufactured from polyester suture. The Continuous loop is used in the same way as surgical suture with the benefit of pre-measured lengths and no need for knot tying. The device is available in 20, 40 & 60 mm.

#### F. Intended Use

The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.

## G. Comparison of Technological Characteristics

The Smith & Nephew Continuous Loop Fixation Device is substantially equivalent in design, materials, function and intended use to the Smith & Nephew Endobutton CL, cleared in K980155. The proposed and the predicate devices both have the same intended use, suture material and are offered in a similar size range.

### H. Summary Performance Data

The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155 . The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.

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OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Deana Boushell Regulatory Affairs Specialist Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K052652

K032032
Trade/Device Name: Smith & Nephew Continuous Loop Fixation Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: September 23, 2005 Received: September 26, 2005

Dear Ms. Boushell:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars manatinent date of the Medical Device American be on to commerce prior to May 28, 1776, the enastinen with the provisions of the Federal Food. Drug, devices that have been icclassified in accreaned with the mail and over all application (PMA). and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, belyer to readers for annual registration, listing of general controls provisions of the fise, 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 If your device is classified (see aboro) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations in may be subject to such additional controller Entisting and to 898. In addition, FDA may be found in the Obas neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuates of would on and other requirements of the Act that IDA has made a dotermination administered by other Federal agencies. You must of ally it cach statutes and regularents and and limited to: registration and listing (21 Compry with an the Act STequirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2- Deana Boushell

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your end finding of substantial equivalence of your device to a legally premaince holicated and caresults 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 other general 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 vours.

Barbara Buehrig
for

Mark N. Melkerson Acting 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): K052652

Device Name: Smith & Nephew Continuous Loop Fixation Device

Indications For Use:

The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and The Simill & Nephtw Continuous Esop I hander = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

NEEDED)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Poueluns for muxin
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number Kos 2452