SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER

K962823 · Synthes (Usa) · HWC · Oct 1, 1996 · Orthopedic

Device Facts

• Record ID: K962823
• Device Name: SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Oct 1, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.

Device Story

Cannulated screw and threaded washer system for small bone fixation; used in hand, wrist, and forefoot surgery. Device provides internal fixation for fractures and arthrodesis. Operated by orthopedic surgeons in clinical/OR settings. Mechanical fixation achieved via screw insertion; threaded washer provides additional surface area/compression. Sterile, single-use device.

Clinical Evidence

Bench testing only; mechanical testing performed to demonstrate equivalence to predicate device.

Technological Characteristics

Materials: 316L stainless steel or Ti-6Al-7Nb. Form factor: 3.0 mm diameter cannulated screw with threaded washer. Sterilization: Gamma radiation.

Indications for Use

Indicated for intra-articular fixation of small bones in hand, wrist, and forefoot; specifically fractures of carpals and metacarpals, carpal and metacarpal arthrodesis, small fragments of hand and wrist, and metatarsal-phalangeal applications.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 2.7 mm Cannulated Screw and Threaded Washer (K962823)

Submission Summary (Full Text)

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SYNTHES
K96 2823
OCT 1 1996

# Attachment VI: Summary of Safety and Effectiveness Information

| Synthes (USA)
1690 Russell Road
P.O. Box 1766
Paoli, PA 19301 | (610) 647 - 9700
Contact: Angela J. Silvestri
July 1996 |
| --- | --- |

Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer is compared to Synthes 2.7 mm Cannulated Screw and Threaded Washer.

Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot. The 3.0 mm Cannulated Screw and Threaded Washer are manufactured from 316L stainless steel or Ti-6Al-7Nb.

Synthes 2.7 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 2.7 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot. The 2.7 mm Cannulated Screw and Threaded Washer are manufactured from 316L stainless steel.

Synthes 3.0 mm Cannulated Screw and Threaded Washer are provided to the user sterile. Gamma Radiation will be used to sterilize the device.

In our opinion, Synthes 3.0 mm Cannulated Screw and Threaded Washer are at least equivalent to Synthes 2.7 mm Cannulated Screw and Threaded Washer, based on mechanical testing of both devices.