COBRA EXTERNAL FIXATOR

K983881 · Orthopaedic Innovations, Inc. · HRS · Dec 4, 1998 · Orthopedic

Device Facts

• Record ID: K983881
• Device Name: COBRA EXTERNAL FIXATOR
• Applicant: Orthopaedic Innovations, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.

Device Story

Cobra External Fixator is a two-piece hinged mechanical device used for orthopedic stabilization. It functions by connecting and stabilizing orthopedic pins or K-wires inserted into bone fragments to maintain proper orientation during healing. Set-screws secure the pins/wires to the fixator and establish the fixation angle. Used in clinical settings by healthcare providers for distal radius fractures. The device provides rigid external support to facilitate bone fragment healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Two-piece hinged external fixator; metallic construction; utilizes set-screws for pin/K-wire securement and angle adjustment. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for patients with fractures near the wrist joint, specifically distal radius fractures including extra-articular, intra-articular, and impacted or die-punch fractures requiring external stabilization via pins or K-wires.

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

• Orthopaedic Innovations Practifix (K960014)
• Synthes AO/ASIF External Fixation Systems
• Howmedica Mini Hoffman External Fixation Systems

Submission Summary (Full Text)

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K983881

## Appendix 4

## Summary of Safety and Effectiveness

| Submitter: | Orthopedic Innovations, Inc.<br>6188 Olson Memorial Highway<br>Minneapolis, MN 55422<br>Telephone: [phone] | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Product: | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories<br>(21 CFR 88.3030) |
| | Common Name: | External Fixation System |
| | Trade/Proprietary Name: | Cobra External Fixator |
| Substantially<br>Equivalent<br>Products | Orthopaedic Innovations Practifix (K960014), Synthes AO/ASIF and<br>Howmedica Mini Hoffman External Fixation Systems | |
| Description: | The device a two-piece hinged external fixator. Set-screws are used to secure<br>orthopedic pins or K-wires to the fixator and establish the fixation angle. | |
| Intended<br>Use: | The intended use is similar to that for other external fixation systems. | |
| Comparison<br>to Substantial<br>Equivalent<br>Products: | All devices have the same intended use, principle or operation and material<br>requirements. Differences between the new and other predicate devices<br>do not affect safety and effectiveness. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 DEC

Mr. Todd J. Hein Vice President Orthopaedic Innovations 6188 Olson Memorial Highway Golden Valley, Minnesota 55422

Re: K983881 Cobra External Fixator Regulatory Class: II Product Code: HRS Dated: October 28, 1998 November 2, 1998 Received:

Dear Mr. Hein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Todd J. Hein

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix 2

## Intended Use

The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.

**Prescription Use**
**(Per 21 CFR 801.109)**

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