HOFFMANN II CARBON CONNECTING ROD
Device Facts
| Record ID | K961916 |
|---|---|
| Device Name | HOFFMANN II CARBON CONNECTING ROD |
| Applicant | Howmedica, Inc. |
| Product Code | JEC · Orthopedic |
| Decision Date | Aug 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.
Device Story
Carbon fiber reinforced epoxy resin connecting rod; component of Hoffmann® II External Fixation System. Functions as structural connecting element for clamps in external fixation frames; stabilizes open/unstable fractures. Used in clinical settings by orthopedic surgeons/physicians. Provides rigid support for pin fixation of fractures; varying diameters/lengths accommodate different anatomic locations. Benefits patient by enabling fracture stabilization in presence of soft tissue injury.
Clinical Evidence
Bench testing only. Static bending strength/stiffness and torsional strength/stiffness compared against Hoffmann® stainless steel and aluminum rods.
Technological Characteristics
Material: Carbon fiber reinforced epoxy resin. Form factor: Connecting rod of varying diameters and lengths. Function: Structural element for external fixation clamps. Energy source: None (mechanical). Sterilization: Not specified.
Indications for Use
Indicated for patients with open and/or unstable fractures where soft tissue injury precludes other fracture treatments; used for stabilization via external fixation.
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
- Hoffmann® Stainless Steel Rods
- Hoffmann® II Aluminum Rods
- Synthes Carbon Fiber Rods
- Monotube External Fixation System Carbon Tubes
Related Devices
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- K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON · Advanced Orthopaedic Solutions, Inc. · Oct 29, 2014
- K110965 — RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM · Renovis Surgical Technologies, LLC · May 11, 2011
