ACUMED TENSION BAND PIN

K964500 · Acu Med, Inc. · HTY · Dec 9, 1996 · Orthopedic

Device Facts

• Record ID: K964500
• Device Name: ACUMED TENSION BAND PIN
• Applicant: Acu Med, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Dec 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine.

Device Story

Acumed Tension Band Pin; orthopedic fixation device used with wire for malleolar, patella, and olecranon fractures. Device diameter 0.0625"; lengths 35mm, 45mm, 55mm. Used in surgical settings by orthopedic surgeons to stabilize bone fragments during tension band wiring. Provides mechanical support for fracture healing. Not for spinal applications.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: 316L stainless steel. Dimensions: 0.0625" diameter; 35mm, 45mm, 55mm lengths. Sterilization: Gamma radiation (minimum 2.5 megarads) to 10⁻⁶ sterility assurance level.

Indications for Use

Indicated for patients requiring fixation of malleolar, patella, and olecranon fractures via tension band wiring procedures. Not indicated for spinal use.

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

• Acumed Fixation Pin
• Howmedica Kirschner Wire

Submission Summary (Full Text)

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ACUMED™

K964500

Quality Orthopaedic Instruments and Implants

Enclosure D - 510(k) Summary

DEC 9 1996

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine. This device has a diameter of .0625" and is available in lengths of 35mm, 45mm, and 55mm. The Acumed Tension Band Pin is manufactured from 316L stainless steel and is provided pre-sterile. Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation. Validation of sterility is maintained on site. Sterility level is 10⁻⁶. Information regarding packaging and labeling have been provided.

The Acumed Tension Band Pin is similar to the Acumed Fixation Pin and the Howmedica Kirschner Wire in material and design. Like Howmedica’s Kirschner Wire, the Acumed Tension Band Pin is intended to be used in tension band wiring procedures addressing malleolar, patella, and olecranon fractures.

Based on the similarities between the Acumed Tension Band Pin and both the Acumed Fixation Pin and Howmedica Kirschner Wire, the safety and effectiveness is expected to be similar to the Acumed Fixation Pin and Howmedica Kirschner Wire.

10950 SW 5th St., Suite 170 • Beaverton, OR 97005 • [phone] • Fax: [phone] • FTBP-02 11/05/96 Page 9 of 11 © 1996, Acumed, Inc.