PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM

K961497 · Howmedica, Inc. · HRS · Jun 28, 1996 · Orthopedic

Device Facts

• Record ID: K961497
• Device Name: PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
• Applicant: Howmedica, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is intended for use in internal fixation of small bones including the hand, foot, and craniomaxillofacial skeleton.

Device Story

System consists of titanium plates and screws for internal bone fixation; plates available in various lengths, thicknesses, and configurations (straight, L, T, Y, Z, rectangular, condylar); screws (1.2-2.7 mm diameter) are fully threaded, self-tapping, with cross-slotted heads; used by surgeons for small bone stabilization; provides mechanical support to facilitate bone healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy plates and screws; 1.2-2.7 mm screw diameters; cross-slotted screw heads; self-tapping design; various plate geometries.

Indications for Use

Indicated for internal fixation of small bones in the hand, foot, and craniomaxillofacial skeleton.

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

• Luhr® Fixation System (Howmedica)
• Synthes® Small Fragment and Mini Set (Synthes USA)
• Wurzburg® Titanium Mini Bone Plates and Screws (Howmedica Leibinger Inc.)

Submission Summary (Full Text)

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K961497

# 510(k) SUMMARY

## Device: Profyle™ Hand and Small Fragment System

| Proprietary Name: | Profyle™ Titanium Hand and Small Fragment System |
| --- | --- |
| Common Name: | Small Bone Plating System |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 888.3030 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87HRS |
| For information contact: | John Dichiara
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: [phone]
Fax: [phone] |

The Profyle Hand and Small Fragment System is a series of titanium plates and screws with plates of varying lengths and thicknesses and configurations including straight, L, T, Y, Z, rectangular, and condylar head options. The system is intended for use in internal fixation of small bones including the hand, foot, and craniomaxillofacial skeleton. These plates are attached to bone using 1.2-2.7 mm diameter titanium bone screws; screw diameter is dependent upon plate thickness. All screws are fully threaded and self-tapping with cross-slotted heads.

The substantial equivalence of these devices is based on equivalence in intended use, design, materials and operating principles to several legally marketed devices including the Luhr® Fixation System (Howmedica), the Synthes® Small Fragment and Mini Set (Synthes USA) and the Wurzburg® Titanium Mini Bone Plates and Screws (Howmedica Leibinger Inc.).

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