SURGICAL DYNAMICS POP RIVET

K961585 · United States Surgical, A Division of Tyco Healthc · JDR · Jul 10, 1996 · Orthopedic

Device Facts

• Record ID: K961585
• Device Name: SURGICAL DYNAMICS POP RIVET
• 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™ Pop Rivet is intended for arthroscopic procedures for reattachment of soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.

Device Story

Surgical Dynamics™ Pop Rivet; arthroscopic soft tissue-to-bone fixation device. Input: surgical site (glenoid labrum/inferior glenohumeral ligament). Device design: pin (distally widening) and cannulated socket (head with circumferential teeth, four ribbed legs). Operation: mechanical fixation of soft tissue to bone during arthroscopic shoulder surgery. Used by orthopedic surgeons in clinical/OR settings. Benefit: stabilization of glenohumeral joint in patients with recurrent dislocation/subluxation.

Clinical Evidence

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

Technological Characteristics

Mechanical fixation device; pin and cannulated socket design; four ribbed legs; circumferential teeth on socket head. Materials: biosafe. Sterilization: identical to predicate.

Indications for Use

Indicated for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.

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® Pop Rivet (K951658)

Submission Summary (Full Text)

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K961585
United States Surgical Corporation
510(k) Premarket Notification
Surgical Dynamics™ Pop Rivet**
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™ Pop Rivet** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Pop Rivet (K951658) and other currently market devices by United States Surgical Corporation.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are indicated for use in soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are comprised of a pin, which widens distally, and a socket, which consists of a cannulated head with circumferential teeth on the underside, as well as four ribbed legs emanating from the underside of the head.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are comprised of biosafe materials.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are manufactured in the same facilities, using the same materials and process methods and controls.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are packaged in similar facilities, with the same materials and with the same process methods and controls.

- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are sterilized in the same facilities, with the same materials and with the same process methods and controls.

** Trademark name not yet determined.
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