Who is the manufacturer of SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM?

Synthes (Usa) filed the 510(k) submission for SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM (K963798).

What is the FDA product code for SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM?

Synthes VDRP (K963798); Synthes STP (K963798).

Who can help prepare an FDA 510(k) submission like SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM

K963798 · Synthes (Usa) · HRS · Nov 27, 1996 · Orthopedic

Device Facts

Record ID	K963798
Device Name	SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
Applicant	Synthes (Usa)
Product Code	HRS · Orthopedic
Decision Date	Nov 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
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.

Indications for Use

Indicated for fixation of fractures and osteotomies of the distal radius in patients requiring volar plate stabilization.

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 VDRP (K963798)
Synthes STP (K963798)

Related Devices

K953644 — VOLAR DISTAL RADIUS PLATE · Synthes (Usa) · Mar 8, 1996
K101936 — CONTOURS VSP III VOLAR PLATING SYSTEM · Orthofix, Inc. · Oct 20, 2010
K052150 — VOLAR PLATE SYSTEM · Dvo Extremity Solutions, LLC · Sep 8, 2005
K042766 — ORTHOFIX VOLAR DISTAL RADIAL PLATE · Orthofix, Inc. · Nov 16, 2004
K022231 — NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM · Osteomedics, Inc. · Sep 13, 2002

Submission Summary (Full Text)

{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.