← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K963798 # SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM (K963798) _Synthes (Usa) · HRS · Nov 27, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K963798 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Nov 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. ## Device Story T-shaped, pre-contoured titanium alloy plate; volar application for distal radius fractures/osteotomies. Head features up to six threaded holes for 2.4 mm cortex screws or 1.8 mm buttress pins; shaft features up to five compression holes for 2.7 mm cortex screws. Plate head and shaft are trimmable to size. Used by orthopedic surgeons in clinical/OR settings for internal fixation. Provides mechanical stability to bone fragments to facilitate healing. ## Clinical Evidence Bench testing only; no clinical data provided. Mechanical testing results indicate equivalence to predicate Synthes STP. ## Technological Characteristics Material: Titanium alloy. Form factor: T-shaped, pre-contoured plate. Dimensions: Head accepts 2.4 mm cortex screws/1.8 mm buttress pins; shaft accepts 2.7 mm cortex screws. Sterilization: Gamma radiation (sterile) or moist heat (non-sterile) per AAMI guidelines. ## 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 VDRP ([K963798](/device/K963798.md)) - Synthes STP ([K963798](/device/K963798.md)) ## 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 K963798 Attachment VIII: Summary of Safety and Effectiveness Information Synthes (USA) 1690 Russell Road Paoli, PA 19301 Contact: Angela Silvestri (610) 647-9700 September 1996 NOV 27 1996 Synthes Ti Alloy VDRP is compared to Synthes VDRP and Synthes STP. Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. The plate is T-shaped (with the head 10° from perpendicular to the shaft), pre-contoured, and available in right and left versions. The head can be cut to size, and has up to six threaded holes that accept either 2.4 mm cortex screws or 1.8 mm buttress pins. The shaft can also be cut to size, has up to five compression holes (two being elongated shaft holes to facilitate positioning), and accepts 2.7 mm cortex screws. As is stated in its name, the plate is manufactured from a Ti Alloy. Synthes Ti Alloy will be provided both sterile and non-sterile. The sterile device will be sterilized by gamma radiation. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline “Good Hospital Practice: Steam Sterilization and Sterility Assurance.” The VDRP is identical to the device described above but it is manufactured from CP Titanium. The Synthes STP is also intended for fixation of fractures and osteotomies, including, but not limited to, the distal radius. It is manufactured from 316L stainless steel. This plate is also T-shaped, is pre-contoured, and is reversible for right and left application. The plate can be cut to size, and has round head and shaft holes (with an elongated shaft hole) that accept 3.5 mm cortex screws and 4.0 mm cancellous screws. Based on the results of mechanical testing, Synthes Ti Alloy VDRP and Synthes VDRP is at least equivalent to the Synthes STP. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K963798](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K963798) **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