← Product Code [JDO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO) · K964259 # SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION (K964259) _Synthes (Usa) · JDO · Jan 9, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO/K964259 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [JDO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO.md) - **Decision Date:** Jan 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## 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 Ti DHS/DCS Lag Screws - Synthes DHS/DCS Lag Screws ## 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 JAN - 9 1997 K964259 Attachment V: Summary of Safety and Effectiveness Information Synthes (USA) 1690 Russell Road Paoli, PA 19301 Contact: Sheri Musgnung (610) 647-9700 October 1996 Synthes DHS/DCS One-Step Lag Screws are compared to Synthes Ti DHS/DCS Lag Screws and Synthes DHS/DCS Lag Screws. 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. Synthes DHS/DCS One-Step Lag Screw has a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The DHS/DCS One-Step Lag Screw is manufactured from stainless steel. Additionally, Synthes Ti-DHS/DCS One-Step Lag Screw and DHS/DCS Lag Screws have a 12.7 mm or a 14.0 mm thread diameter and are available in various lengths. The Ti-DHS/DCS One-Step Lag Screw is manufactured from Titanium Alloy. The DHS/DCS Lag Screw is manufactured from stainless steel. Synthes DHS/DCS One-Step Lag Screw will be provided sterile; gamma radiation will be used to sterilize the device. Based upon the information identified above, Synthes DHS/DCS One-Step Lag Screw is equivalent to Synthes Ti-DHS/DCS One-Step Lag Screw and Synthes DHS/DCS Lag Screw. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO/K964259](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDO/K964259) **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