CANNULATED PLUS HIP SCREW (STERILE)
Device Facts
| Record ID | K955837 |
|---|---|
| Device Name | CANNULATED PLUS HIP SCREW (STERILE) |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | HWC · Orthopedic |
| Decision Date | Mar 4, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to: 1. femoral neck fractures; 2. arthrodesis of the hip; 3. femoral condyle fractures; 4. tibial plateau fractures; 5. ankle malleolar fractures; or 6. elbow fractures
Device Story
Cannulated bone screw; optional beveled washer for osteoporotic bone; available in various sizes. Used by orthopedic surgeons for internal fixation of cancellous bone fractures or arthrodesis. Device provides mechanical stabilization of bone fragments to facilitate healing.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Cannulated bone screw and optional washer; material: stainless steel; sterile.
Indications for Use
Indicated for patients requiring fixation of cancellous bone, including femoral neck fractures, hip arthrodesis, femoral condyle fractures, tibial plateau fractures, ankle malleolar fractures, and elbow fractures.
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
- Cannulated PLUS™ Hip Screw
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