K Number
K983881
Device Name
COBRA EXTERNAL FIXATOR
Date Cleared
1998-12-04

(32 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The device a two-piece hinged external fixator. Set-screws are used to secure orthopedic pins or K-wires to the fixator and establish the fixation angle.
More Information

Not Found

No
The description focuses on a mechanical external fixator and does not mention any software, algorithms, or data processing that would indicate AI/ML.

Yes
Explanation: The device is an external fixator designed to stabilize bone fragments for healing, which directly contributes to the treatment of a medical condition (fractures).

No

The device is an external fixator designed to stabilize bone fragments for healing, not to diagnose medical conditions.

No

The device description clearly states it is a "two-piece hinged external fixator" that uses "set-screws" to secure "orthopedic pins or K-wires," indicating it is a physical hardware device.

Based on the provided information, the Cobra device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Cobra Device Function: The Cobra device is an external fixator designed to stabilize bone fractures. It is applied externally to the body and directly interacts with bone pins/wires. It does not analyze any biological specimens.
  • Intended Use: The intended use clearly states its purpose is to "externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal." This is a mechanical function for fracture management, not a diagnostic test.

Therefore, the Cobra device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for 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.

Product codes

HRS

Device Description

The device a two-piece hinged external fixator. Set-screws are used to secure orthopedic pins or K-wires to the fixator and establish the fixation angle.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fractures near the wrist joint, specifically fractures of the distal extremity of the radius

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K960014

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.

0

K983881

Appendix 4

Summary of Safety and Effectiveness

| Submitter: | Orthopedic Innovations, Inc.
6188 Olson Memorial Highway
Minneapolis, MN 55422
Telephone: (612) 591-0001 | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Product: | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories
(21 CFR 88.3030) |
| | Common Name: | External Fixation System |
| | Trade/Proprietary Name: | Cobra External Fixator |
| Substantially
Equivalent
Products | Orthopaedic Innovations Practifix (K960014), Synthes AO/ASIF and
Howmedica Mini Hoffman External Fixation Systems | |
| Description: | The device a two-piece hinged external fixator. Set-screws are used to secure
orthopedic pins or K-wires to the fixator and establish the fixation angle. | |
| Intended
Use: | The intended use is similar to that for other external fixation systems. | |
| Comparison
to Substantial
Equivalent
Products: | All devices have the same intended use, principle or operation and material
requirements. Differences between the new and other predicate devices
do not affect safety and effectiveness. | |

4 ;

4 1998 DEC

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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.

2

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

3

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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