LRN · Wire, Surgical
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | LRN |
|---|---|
| Device Name | Wire, Surgical |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | T. Korossurgical Instruments Corp. | Dec 4, 2000 | SESE |
| K990355 | STAINLESS STEEL SOFT SUTURE WIRE | Bregma International Trading Company , Ltd. | Jul 8, 1999 | SESE |
| K971682 | J-FX CERCLAGE SYSTEM | Johnson & Johnson Professionals, Inc. | Jun 27, 1997 | SESE |
| K952783 | OXBORO-MEDICAL PIN COVERS | Oxboro Medical Intl., Inc. | Sep 15, 1995 | SESE |
| K942603 | ORTHOPAEDIC WIRES | Acu Med, Inc. | Nov 9, 1994 | SESE |
| K900926 | TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) | Howmedica Corp. | Apr 23, 1990 | SESE |
| K892651 | SONGER WIRING SYSTEM | Danek Medical, Inc. | Jul 25, 1989 | SESE |
| K864375 | TYPE 316L COTTER WIRE | Winn Hirsch & Assoc. | May 20, 1987 | SN |
Top Applicants
- Winn Hirsch & Assoc. — 1 clearance
- T. Korossurgical Instruments Corp. — 1 clearance
- Oxboro Medical Intl., Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Howmedica Corp. — 1 clearance
