HUMERUS WIRES

K964243 · Compagnie Financiere & Medicale (Cf&M) · HSB · Dec 5, 1996 · Orthopedic

Device Facts

• Record ID: K964243
• Device Name: HUMERUS WIRES
• Applicant: Compagnie Financiere & Medicale (Cf&M)
• Product Code: HSB · Orthopedic
• Decision Date: Dec 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone.

Device Story

Internal wire fixation device; used for humeral fracture fixation and bone reconstruction. Implanted in humerus; provides structural support. Operated by orthopedic surgeons in clinical/surgical settings. Device design similar to existing fixation pins/wires; lacks locking screw mechanism. Benefits patient by stabilizing humeral fractures to facilitate healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Internal wire fixation device. Manufactured from materials previously utilized in FDA-cleared medical devices. Design is a smooth fixation pin/wire. Non-locking configuration.

Indications for Use

Indicated for internal fixation of humeral fractures and/or reconstruction of the humeral bone in patients requiring orthopedic stabilization.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Applied Osteo Systems True/Flex IM Rod System for the Humerus, Radius, and Ulna (K902264, K913949)
• Richards Ender Pins (K811002)
• O'Tec Corporation Rush Pins (K905341)
• Onyx Corporation Rush Pins (K903261)

Submission Summary (Full Text)

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FERGUSON MEDICAL

916-342-4133

FAX: [phone]

20 September 1996

DEC - 5 1996

K964243

510(k) SUMMARY

The 510(k) summary information required by CFR 807.92 is as follows:

A. Classification name: Pin, fixation, smooth

Common/usual name: Fixation wire, fixation pin, nail, rod, and others

Proprietary name: Humerus Wires

B. Substantial equivalence: Applied Osteo Systems True/Flex IM Rod System for the Humerus, Radius, and Ulna (K902264, K913949), Richards Ender Pins (K811002), O'Tec Corporation and Onyx Corporation Rush Pins (K905341 and K903261, respectively), and others.

C. Device description: The Humerus Wires device is an internal wire fixation device to be used in the fixation of humeral fractures.

D. Intended use: The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone.

E. Technological characteristics: The Humerus Wires

3407 Bay Avenue • Chico, California 95973 • USA

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device is similar to predicate devices in its design, function, and intended use.

The device is similar to certain predicates which do not utilize a locking screw, but it is unlike predicates which do utilize such a locking component.

The Humerus Wires device is manufactured from materials presently and/or previously utilized in FDA-cleared medical devices.

Submitted,
FERGUSON MEDICAL
FDA Establishment Registration Number 2937794

Frank Ferguson
Official Correspondent