LYT · Fixation Accessory
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | LYT |
|---|---|
| Device Name | Fixation Accessory |
| 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.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040363 | CERAMIC TIPPED SKULL PIN | The Jerome Group, Inc. | Apr 12, 2004 | SESE |
| K983685 | BONE BAND | Chapel and Assoc. | Dec 4, 1998 | SESE |
| K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS | Osteonics Corp. | May 5, 1998 | SESE |
| K914812 | K-CAP-E, STERILE | Westcon Orthopedics, Inc. | Jan 9, 1992 | SESE |
| K912762 | K-CAP-I, STERILE | Westcon Orthopedics, Inc. | Jul 18, 1991 | SESE |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | Micro-Aire Surgical Instruments, Inc. | Sep 14, 1990 | SESE |
| K902053 | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP | Westcon Orthopedics, Inc. | Sep 14, 1990 | SESE |
| K883576 | HORIZON ORTHOPEDIC PIN PROTECTOR | Horizon Medical, Inc. | Sep 30, 1988 | SESE |
| K831072 | JURGAN PIN BALL | Jurgan Development & Mfg., Ltd. | Jun 8, 1983 | SESE |
Top Applicants
- Westcon Orthopedics, Inc. — 3 clearances
- The Jerome Group, Inc. — 1 clearance
- Osteonics Corp. — 1 clearance
- Micro-Aire Surgical Instruments, Inc. — 1 clearance
- Jurgan Development & Mfg., Ltd. — 1 clearance
