SUTURE ANCHOR

K961578 · United States Surgical, A Division of Tyco Healthc · JDR · Jul 10, 1996 · Orthopedic

Device Facts

• Record ID: K961578
• Device Name: SUTURE ANCHOR
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: JDR · Orthopedic
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgical Dynamics™ Suture Anchor is intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.

Device Story

Suture anchor with attached polyester suture; placed into predrilled bone hole for soft tissue-to-bone anchorage. Used in arthroscopic procedures for shoulder, wrist, and hand. Operated by surgeons. Device provides mechanical fixation of soft tissue to bone.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and manufacturing process comparison to predicate.

Technological Characteristics

Suture anchor with attached polyester suture. Comprised of biosafe materials. Sterile, single-use device. Mechanical fixation principle.

Indications for Use

Indicated for attachment of soft tissue to bone in shoulder, wrist, and hand procedures.

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

• Poly-Medics Lactosorb® Suture Anchor (K954443)

Submission Summary (Full Text)

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K96 1578

United States Surgical Corporation

510(k) Premarket Notification

Surgical Dynamics™ Suture Anchor**

JUL 10 1996

# SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

As is evident in the submitted information on indications, design, materials, manufacturing, sterilization, packaging and method of use, the Surgical Dynamics™ Suture Anchor** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Suture Anchor (K954443) and other currently market devices by United States Surgical Corporation.

- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are comprised of biosafe materials.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are manufactured in the same facilities, using the same materials and process methods and controls.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are packaged in similar facilities, with the same materials and with the same process methods and controls.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are sterilized in the same facilities, with the same materials and with the same process methods and controls.

** Trademark name not yet determined.