TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
Device Facts
| Record ID | K953607 |
|---|---|
| Device Name | TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) |
| Applicant | Synthes (Usa) |
| Product Code | JDO · Orthopedic |
| Decision Date | Mar 8, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti. LC-DHS) is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Device Story
Sliding hip screw plate device; treats intertrochanteric, subtrochanteric, and basilar neck fractures; reconstructs stable medial buttress. Manufactured from titanium alloy. Used by orthopedic surgeons in clinical/surgical settings for internal fixation of fractures. Provides mechanical stabilization of bone fragments to facilitate healing.
Clinical Evidence
Bench testing only.
Technological Characteristics
Titanium alloy construction; sliding hip screw plate design; gamma radiation sterilization for sterile units; steam sterilization (pre-vacuum or gravity displacement) for non-sterile units.
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 Limited Contact Dynamic Hip Screw (LC-DHS) Implant
- Synthes Dynamic Hip Screw (DHS) Implant
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- K970503 — DEPUY ACE TROCHANTERIC SIDE PLATE · Depuy Ace Medical Co. · Apr 30, 1997
- K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW · Smith & Nephew, Inc. · Apr 10, 2008
