ACE HUMERUS & RADIUS PLATES

K955472 · Ace Medical Co. · HRS · Apr 1, 1996 · Orthopedic

Device Facts

• Record ID: K955472
• Device Name: ACE HUMERUS & RADIUS PLATES
• Applicant: Ace Medical Co.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large. The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length. Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.

Device Story

Anatomically contoured titanium alloy bone plates; used for internal fixation of distal radius and proximal humerus fractures; requires cortical or cancellous bone screws for attachment; plates available in multiple hole configurations and sizes; used by orthopedic surgeons in clinical settings; provides mechanical stabilization of bone fractures to facilitate healing; performance validated via static cantilever bending tests compared to predicate devices.

Clinical Evidence

Bench testing only. Static cantilever bending tests performed on proximal humerus, volar distal radius, and dorsal distal radius plates. Results compared to Synthes and DePuy predicate devices; ACE plates demonstrated comparable bending strength.

Technological Characteristics

Biocompatible titanium alloy construction; anatomically contoured bone plates; configurations include left/right, multiple hole counts (3, 5), and sizes (small, large); mechanical fixation via cortical/cancellous bone screws; non-powered, passive orthopedic implant.

Indications for Use

Indicated for internal fixation of distal radius fractures and proximal humerus fractures in patients requiring bone 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

• DePuy ORIF Small Fragment Plates
• Synthes Small Plates
• Synthes Small Titanium Plates

Submission Summary (Full Text)

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K955472

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## ACE UPPER EXTREMITY PLATE SYSTEM

Ace Medical Company
2260 East El Segundo Blvd.
El Segundo, CA 90245
Phone [phone]

APR 1

**Contact Person:**
Nancy Giezen
Senior Regulatory Affairs Specialist

Paul Doner
Director, Regulatory/Clinical Affairs

**Proprietary Name:**
ACE Humerus Plates
ACE Radius Plates

**Common Name:**
Bone Plate

**Classification Name:**
Single / Multiple Component Metallic Bone Fixation Appliance and Accessories, 21 CFR 888.3030

**Proposed Regulatory Class:**
Class II

**Classification Panel:**
Orthopaedic Device Panel

**Device Product Code:**
87HRS Plate, Fixation, Bone

## Device Description:

The ACE Humerus Plates and Radius Plates are anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws. The humerus plates will offered in two configurations for both the left side and the right side. The plates are offered in three hole and five hole configurations.

The ACE Radius plates are also offered in a right and left configuration both for volar fixation and dorsal fixation. The plates are offered in a large and a small size.

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## ACE UPPER EXTREMITY PLATE SYSTEM

### Intended Use:

The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.

The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.

Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.

### Substantial Equivalence:

The ACE Humerus Plate and Radius Plate systems are considered substantially equivalent to the DePuy ORIF Small Fragment Plates and the Synthes Small Plates and Small Titanium Plates.

### Performance Data:

The ACE Humerus and Radius plates were tested in static bending and compared to the Synthes (USA) and the DePuy plates. Three types of plates (proximal humerus, volar distal radius and dorsal distal radius) were tested by applying static cantilever bending forces on the shaft/buttress interface of the plate. The ACE Plates were comparable in bending strength to the predicate device.

### Safety and Effectiveness:

The upper extremity plates are manufactured of a biocompatible titanium alloy, commonly used in the orthopedic industry. The plates were shown to exhibit strength characteristics comparable to the predicate device. Thirdly, no new indications have been introduced with these devices. Therefore, the ACE upper extremity plates are considered to be a safe and effective means of fracture fixation.