SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II

K020948 · Smith & Nephew, Inc. · JDR · Oct 9, 2002 · Orthopedic

Device Facts

• Record ID: K020948
• Device Name: SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
• Applicant: Smith & Nephew, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew SURETAC® Fixation Device is indicated for rotator cuff repair.

Device Story

SURETAC® is a bioresorbable fixation device used in orthopedic surgery. Composed of polyglycolic acid (PGA) and trimethylene carbonate (TMC) copolymer, the device is designed to secure tissue during rotator cuff repair. It functions by providing mechanical fixation and is subsequently resorbed by the body via hydrolysis and metabolism. The device is intended for use by surgeons in a clinical or operating room setting. It provides a stable anchor for tissue repair, facilitating healing before the material is fully metabolized. No electronic or software components are involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to previously cleared predicate devices.

Technological Characteristics

Bioresorbable fixation fastener composed of PGA/TMC copolymer. Material is biocompatible and degrades in vivo via hydrolysis. Mechanical fixation device; no energy source, connectivity, or software.

Indications for Use

Indicated for rotator cuff repair in patients requiring surgical fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Smith & Nephew, SURETAC® Fixation Device (K911837)
• Smith & Nephew, SURETAC® Expanded Indication (K931819)

Submission Summary (Full Text)

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K0L0948 page 1/2

# Section 7- 510k Summary

| 7.1 Statement | This 510k summary is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2 Submitter | Smith and Nephew, Inc.<br>Endoscopy Division<br>160 Dascomb Rd.<br>Andover, Ma. 01810 |
| 7.3 Company<br>Contact | Jason Bilobram<br>Regulatory Affairs Specialist<br>[phone] |
| 7.4 Device<br>Name | Proprietary Name: SURETAC® Expanded Indication II<br>Common Name: SURETAC® Fixation Device<br>Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener (JDR) |
| 7.5 Predicate<br>Legally<br>Marketed<br>Devices | <ul><li>Smith &amp; Nephew, SURETAC® Fixation Device (K911837)</li><li>Smith &amp; Nephew, SURETAC® Expanded Indication (K 931819)</li></ul> |
| 7.6 Device<br>Description | The PGA/TMC SureTac is composed of bioresorbable and biocompatible polymers that have been used in various surgical procedures for many years. Polyglycolic Acid (PGA) and Trimethylene carbonate (TMC) copolymer degrades and resorbs <i>In Vivo</i> by hydrolysis and are metabolized by the body. In animal studies PGA/TMC, also know as, Maxon have been shown to be biocompatible in both soft tissue and bone tissue. |
| 7.7 Indications<br>for Use | The Smith & Nephew SURETAC® Fixation Device is indicated for rotator cuff repair. |

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7.8 Substantial Equivalence

The SURETAC® Fixation Device is substantially equivalent in design, material, packaging materials and method of sterilization to the following currently marketed devices:

- Smith & Nephew, SURETAC® Fixation Device (K911837) ●
- Smith & Nephew, SURETAC® Expanded Indication (K 931819) .
- The only difference between the proposed and predicate devices is the expansion of the . patient population to include rotator cuff repair.

Applicant:

Jose Beloh

Jason Bilobram Regulatory Affairs Specialist

Date: 03/21/2002

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jason Bilobram Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road

Andover, Massachusetts 01810

Re: K020948

Trade/Device Name: SURETAC® Expanded Indications II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDR Dated: July 17, 2002 Received: July 18, 2002

Dear Mr. Bilobram:

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 - Mr. Jason Bilobram

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21CFR 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,

Stpt Rlvorlu

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If Known): K020948

Device Name: SURETAC® Expanded Indications II

.

:

Indications for Use: Indicated for use in Rotator Cuff Repair

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Styt Rhodes

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number k020948

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use \$\mathcal{N}\$/6