Who is the manufacturer of VOLAR DISTAL RADIUS PLATE?

Synthes (Usa) filed the 510(k) submission for VOLAR DISTAL RADIUS PLATE (K953644).

What is the FDA product code for VOLAR DISTAL RADIUS PLATE?

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

What is the regulatory pathway for VOLAR DISTAL RADIUS PLATE?

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

Who can help prepare an FDA 510(k) submission like VOLAR DISTAL RADIUS PLATE?

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.

VOLAR DISTAL RADIUS PLATE

K953644 · Synthes (Usa) · HRS · Mar 8, 1996 · Orthopedic

Device Facts

Record ID	K953644
Device Name	VOLAR DISTAL RADIUS PLATE
Applicant	Synthes (Usa)
Product Code	HRS · 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 Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.

Device Story

Volar Distal Radius Plate; T-shaped titanium plate; pre-contoured for volar aspect; right/left versions; head accepts 2.4 mm Cortex Screws or 1.8 mm Buttress Pins; shaft accepts 2.7 mm Cortex Screws; used by orthopedic surgeons in clinical/OR settings for fracture fixation; provides mechanical stabilization to bone fragments to facilitate healing.

Clinical Evidence

Bench testing only; mechanical testing results demonstrate equivalence to predicate device.

Technological Characteristics

Material: Commercially pure titanium. Form factor: T-shaped, pre-contoured plate. Dimensions: Head angled 10° from perpendicular to shaft; head/shaft cut-to-size. Fixation: Threaded holes for 2.4 mm Cortex Screws/1.8 mm Buttress Pins; compression holes for 2.7 mm Cortex Screws. Sterilization: Gamma radiation (sterile) or moist heat (non-sterile) per AAMI steam sterilization 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 Small T-Plate

Related Devices

K963798 — SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM · Synthes (Usa) · Nov 27, 1996
K981283 — ROGACHEFSKY DISTAL RADIUS PLATES · Howmedica, Inc. · Jun 10, 1998
K052150 — VOLAR PLATE SYSTEM · Dvo Extremity Solutions, LLC · Sep 8, 2005
K994061 — LOCON-T DISTAL RADIAL PLATE · Wrightmedicaltechnologyinc · Feb 14, 2000
K101936 — CONTOURS VSP III VOLAR PLATING SYSTEM · Orthofix, Inc. · Oct 20, 2010

Submission Summary (Full Text)

{0} SYNTHES K 95-244 Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary] SYNTHES (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri August 4, 1995 Device: Synthes Volar Distal Radius Plate is compared to Synthes Small T-Plate. Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. It is manufactured from commercially pure titanium. The plate is T-shaped, with the head 10° from perpendicular to the shaft, is pre-contoured, and is available in right and left versions. The head can be cut to size; it has up to six threaded holes, and accepts either 2.4 mm Cortex Screws or 1.8 mm Buttress Pins. The shaft can also be cut to size, and has up to five compression holes, two being elongated shaft holes to facilitate positioning, and accepts 2.7 mm Cortex Screws. Synthes Volar Distal Radius Plate 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 recommended steam sterilization parameters for the non-sterile device are as follows: | Method | Cycle | Time | Temperature | | --- | --- | --- | --- | | Steam | Pre-vacuum | 6 minutes | 132° - 135°C | | Steam | Gravity Displacement | 15 minutes | 132° - 135°C | The Synthes Small T-Plate 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 Volar Distal Radius Plate is at least equivalent to the Synthes Small T-Plate.