THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*

K973281 · United States Surgical, A Division of Tyco Healthc · MAI · Nov 3, 1997 · Orthopedic

Device Facts

• Record ID: K973281
• Device Name: THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: MAI · Orthopedic
• Decision Date: Nov 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgical Dynamics S•D sorb E-Z Tac is indicated for use in soft tissue to bone fixation for rotator cuff repairs and for reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

Device Story

Surgical Dynamics S•D sorb E-Z Tac is an absorbable implant designed for affixing soft tissue to bone. Used by surgeons in clinical settings for orthopedic procedures, specifically rotator cuff repairs and glenoid labrum or inferior glenohumeral ligament reattachment. The device functions as a mechanical fixation tool to secure soft tissue to bone. It is manufactured from biocompatible materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbable implant; biocompatible materials compliant with ISO 10993-1.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation, specifically for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

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

• Surgical Dynamics S•D sorb E-Z Tac (K961585)
• Surgical Dynamics S•D sorb Suture Anchor (K961578)
• Mitek GII Bone Anchor (K953877)

Submission Summary (Full Text)

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K973281 Nov. 3, 1997

## Summary of Safety and Effectiveness IX.

United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856

Sharon L. Murphy CONTACT PERSON:

- August 28, 1997 DATE PREPARED:
Staple, Fixation, Bone CLASSIFICATION NAME:

- Pop Rivet COMMON NAME:
Surgical Dynamics* S.D sorb* E-Z Tac* PROPRIETARY NAME:

Surgical Dynamics* S•D sorb* E-Z Tac* (K961585) PREDICATE DEVICES: Surgical Dynamics* S.D sorb* Suture Anchor (K961578) Mitek GII Bone Anchor (K953877)

- The Surgical Dynamics* S.D sorb* E-Z Tac* is an DEVICE DESCRIPTION: absorbable implant to be used for affixing soft tissue to bone.
- The Surgical Dynamics* S•D sorb* E-Z Tac* is indicated INTENDED USE: for use in soft tissue to bone fixation for rotator cuff repairs and for reattachment of the glenoid labrum and/or inferior glenohumeral ligament.
- Like all the devices manufactured by United States MATERIALS: Surgical Corporation, the Surgical Dynamics* S.D sorb* E-Z Tac* device is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.

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Image /page/1/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 1997

Ms. Sharon L. Murphy ·Senior Requlatory Affairs Associate United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Re: K973281 Trade Name: Surgical Dynamics* SD sorb E-Z Tac* Requlatory Class: II Product Codes: MAI and JDR Dated: August 28, 1997 Received: September 2, 1997

Dear Ms. Murphy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 cláss II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Sharon L. Murphy

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Witton, Ph.D., M.

Cella 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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## Indications for Use IV.

K973281 510(k) Number (if known):

Surgical Dynamics* EZ-Tac* Device Name:

## Indications For Use:

indications i or 550.
The Surgical Dynamics ' S•D sorb • E-Z Tac' is indicated for use in soft tissue to bone fixation for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

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behind

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

Concurrence of CDRH , Office of Device Evaluation (ODE)

OR Over-The-Counter Prescription Use: _ メ Use:

(Per 21 CFR 801.109)

(Division Sign-Off) Division of General Restorative Device 510(k) Number .

Premarket Notification United States Surgical Corporation * Trademark of United States Surgical Corporation Page 8

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