← Product Code [JDO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO) · K953607 # TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) (K953607) _Synthes (Usa) · JDO · Mar 8, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO/K953607 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [JDO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO.md) - **Decision Date:** Mar 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SYNTHES K953607 **Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]** Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301 (610) 647-9700 Contact: Angela J. Silvestri August 1, 1995 Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti. LC-DHS) is compared to Synthes Limited Contact Dynamic Hip Screw (LC-DHS) Implant and Synthes Dynamic Hip Screw (DHS) Implant. Synthes 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. The device is manufactured from a Titanium Alloy. Synthes DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The device is manufactured from stainless steel. Synthes will provide the Ti. LC-DHS sterile or non-sterile. Sterile devices will be gamma radiated. Of course, non-sterile devices must be sterilized prior to use, Recommended Sterilization parameters are: | Method | Cycle | Temperature | Time | | --- | --- | --- | --- | | Steam | Pre-vacuum | 132° C - 135° C | 6 min. | | Steam | Gravity Displacement | 132° C - 135° C | 15 min. | Based on mechanical test results, the Ti. LC-DHS design has been found to be substantially equivalent to the DHS design. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO/K953607](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO/K953607) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com