KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN

K961522 · Synvasive Technology, Inc. · HTY · Sep 23, 1996 · Orthopedic

Device Facts

• Record ID: K961522
• Device Name: KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
• Applicant: Synvasive Technology, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Sep 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

Device Story

Stainless steel Kirschner wires (K-wires) and Steinmann pins; used for bone fragment fixation. Driven through bone via powered rotary device; left implanted to stabilize bone during healing. Single-use; supplied sterile or non-sterile. Used by surgeons in clinical/OR settings to facilitate fracture healing.

Clinical Evidence

Bench testing only; materials conform to ASTM specifications for medical device use.

Technological Characteristics

Stainless steel fixation pins/wires; smooth or threaded. Materials conform to ASTM specifications. Powered rotary insertion. Single-use.

Indications for Use

Indicated for patients requiring bone fragment fixation to facilitate healing; used for drawing two or more bone fragments together.

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

• Standard K-Wires and Steinmann Pins (DePuy, Howmedica, MicroAire, Zimmer)

Submission Summary (Full Text)

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K961522
SEP 23 1996

ATTACHMENT 11

510(k) SUMMARY

Submitting Company: SYNVASIVE Technology, Inc.
4925 Robert J. Matthews Pkwy.
El Dorado Hills, CA 95762

Telephone: [phone]

Fax: [phone]

Contact Person: Michael G. Fisher
Vice President

Date Prepared: April 8, 1996

Common Product Name: Kirschner Wires (K-Wires) and Steinmann Pins

Classification Name: Smooth or Threaded Metallic Bone Fixation
Fastener (per 21 CFR 888.3040)

Product Description: The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fragments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.

Intended Use: The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

Substantial Equivalence: The fixation devices are substantially equivalent to standard K-Wires and Steinmann Pins legally marketed by many companies including DePuy, Howmedica, MicroAire, and Zimmer.

Technological Characteristics: The fixation devices have the same technological characteristics as all of the predicate devices.

Safety and Effectiveness Testing: All materials used in the fixation devices conform with ASTM specifications for medical device use. Material specifications are tested on a design basis and certificates of conformance to specifications are supplied with each material batch.

SYNVASIVE Technology, Inc.
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