SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM

K962616 · Synthes (Usa) · HRS · Sep 3, 1996 · Orthopedic

Device Facts

• Record ID: K962616
• Device Name: SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Sep 3, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Dorsal Distal Radius Plate is intended for fixation of fractures, osteotomies and carpal fusions involving the distal radius, applied to the dorsal aspect.

Device Story

Synthes Dorsal Distal Radius Plate; PI-shaped titanium alloy plate; precontoured for dorsal distal radius; features two proximal shaft arms and one distal head arm; proximal arms include four compression holes and one round hole for 2.7 mm cortex screws; distal head includes seven internally threaded holes for 1.8 mm threaded head buttress pins or 2.4 mm cortex screws; plate can be cut to size; available in left and right versions; used by orthopedic surgeons for internal fixation of distal radius fractures, osteotomies, and carpal fusions.

Clinical Evidence

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

Technological Characteristics

Material: Titanium alloy. Design: PI-shaped, precontoured, left/right versions. Fixation: 2.7 mm cortex screws (proximal), 1.8 mm threaded head buttress pins or 2.4 mm cortex screws (distal).

Indications for Use

Indicated for patients requiring fixation of fractures, osteotomies, and carpal fusions of the distal radius.

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

• Zimmer Small T-Plate, Oblique

Submission Summary (Full Text)

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SYNTHES
K 962616
SEP 3 1996

# Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]

SYNTHES (USA) [phone]
1690 Russell Road Contact: Angela Silvestri
Paoli, PA 19301 July 1996

Device: Synthes Dorsal Distal Radius Plate is compared to the Zimmer Small T-Plate, Oblique.

Synthes Dorsal Distal Radius Plate is intended for fixation of fractures, osteotomies and carpal fusions involving the distal radius, applied to the dorsal aspect. It is manufactured from a Titanium alloy.

Synthes Dorsal Distal Radius Plate is PI shaped, with two proximal arms (shaft) and one distal arm (head). The plate is precontoured, and is available in right and left versions. The plate can be cut to size, and there are four compression holes and one round hole in each proximal arm (shaft) that accept 2.7 mm cortex screws, and seven internally threaded holes in the distal arm (head) that accept 1.8 mm threaded head buttress pins or 2.4 mm cortex screws.

The Zimmer Oblique T-Plate is intended for condylar fixation.

Synthes Dorsal Distal Radius Plate is at least equivalent to the Zimmer Small T-Plate, Oblique based on the mechanical test results of both devices.