SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
Device Facts
| Record ID | K964259 |
|---|---|
| Device Name | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION |
| Applicant | Synthes (Usa) |
| Product Code | JDO · Orthopedic |
| Decision Date | Jan 9, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Device Story
Orthopedic fixation device; lag screw used with Dynamic Hip Screw (DHS) or Dynamic Condylar Screw (DCS) plates. Input: surgical placement into bone fractures. Function: provides mechanical stabilization of intertrochanteric, subtrochanteric, and basilar neck fractures. Output: physical bone fixation. Used in clinical/surgical settings by orthopedic surgeons. Benefit: facilitates fracture healing through stable internal fixation.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Materials: stainless steel. Thread diameters: 12.7 mm or 14.0 mm. Sterilization: gamma radiation. Form factor: lag screw for use with DHS/DCS plates.
Indications for Use
Indicated for patients with stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures where a stable medial buttress can be reconstructed.
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 Ti DHS/DCS Lag Screws
- Synthes DHS/DCS Lag Screws
Related Devices
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- K970503 — DEPUY ACE TROCHANTERIC SIDE PLATE · Depuy Ace Medical Co. · Apr 30, 1997
- K953607 — TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) · Synthes (Usa) · Mar 8, 1996
- K040656 — MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW · Smith & Nephew, Inc. · May 25, 2004
- K020677 — GAMMA 3 LAG SCREW · Howmedica Osteonics Corp. · Mar 29, 2002
