CANCELLOUS SCREW WASHER
Device Facts
| Record ID | K963420 |
|---|---|
| Device Name | CANCELLOUS SCREW WASHER |
| Applicant | Orthopaedic Biosystems, Ltd. |
| Product Code | HTN · Orthopedic |
| Decision Date | Nov 15, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Cancellous Screw Washers are washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, metacarpals, and tarsal bones.
Device Story
Cancellous Screw Washer; used as support under bone screw head; provides stability for cancellous bone screws during fracture fixation; indicated for metatarsal, metacarpal, and tarsal bone procedures; used by surgeons in clinical/OR settings; enhances screw fixation; benefits patient by providing structural support to bone fragments.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and material similarity to predicate.
Technological Characteristics
Materials: Titanium or Stainless Steel. Form factor: Washer for cancellous bone screws. Function: Mechanical support under screw head.
Indications for Use
Indicated for fracture fixation of metatarsals, metacarpals, and tarsal bones in patients requiring cancellous bone screw support.
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
- Synthes Screw Washer
Related Devices
- K955837 — CANNULATED PLUS HIP SCREW (STERILE) · Wrightmedicaltechnologyinc · Mar 4, 1996
- K150376 — Sonoma Cancellous Bone Screw and Washer · Sonoma Orthopedics Products, Inc. · Jun 12, 2015
- K190324 — OrthoPediatrics Cannulated Screw System · OrthoPediatrics Corp. · Jul 5, 2019
- K251555 — Ultra Compression Screw System · Pace Surgical · Nov 6, 2025
- K080101 — AAP CANNULATED SCREW AND DARCO HEADED SCREW · Aap Implantate AG · Mar 25, 2008
