DEPUY ACE TROCHANTERIC SIDE PLATE

K970503 · Depuy Ace Medical Co. · HRS · Apr 30, 1997 · Orthopedic

Device Facts

• Record ID: K970503
• Device Name: DEPUY ACE TROCHANTERIC SIDE PLATE
• Applicant: Depuy Ace Medical Co.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.

Device Story

Metallic bone fixation plate; component of Captured Hip Screw (CHS) system. Input: surgical site anatomy; output: mechanical stabilization of femoral fractures. Proximal extension with triangular hole configuration allows screw placement for greater trochanter fixation and femoral head anti-rotation. Used in orthopedic surgery; implanted by surgeons. Provides structural support for fracture healing; improves control of comminuted trochanteric fragments.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Ti-6Al-4V alloy. Form factor: Bone fixation plate with proximal extension and 4, 6, or 8 hole configurations. Mechanical fixation via screws. Non-powered, passive implant.

Indications for Use

Indicated for patients requiring fixation for osteotomies, arthrodeses, and hip fractures, including intertrochanteric, intracapsular, and subtrochanteric fractures, specifically those with comminution of the greater trochanter.

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 ACE Captured Hip Screw Side Plate

Submission Summary (Full Text)

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K970503
APR 30 1997

# 510(k) SUMMARY

**NAME OF FIRM:**
DePuy ACE Medical Company
2260 East El Segundo Blvd.
El Segundo, CA 90245

**510(k) CONTACT PERSON**
Kathleen A. Dragovich
Regulatory Affairs Specialist
DePuy ACE Medical Company

**TRADE NAME**
DePuy ACE Trochanteric Side Plate

**COMMON NAME**
Bone Fixation Plate

**CLASSIFICATION**
Single/Multiple Component Metallic Bone Fixation
Appliance and Accessories, 21 CFR 888.3030

**DEVICE PRODUCT CODE**
87 HRS Plate, Fixation, Bone

**SUBSTANTIALLY EQUIVALENT DEVICE**
DePuy ACE Captured Hip Screw Side Plate

**INTENDED USE:**
The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.

## DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The DePuy ACE Trochanteric Side Plate is an optional component of the DePuy ACE Captured Hip Screw System (CHS). The new plate has a proximal extension with three holes placed in a triangular configuration. The proximal extension is designed for fixation of trochanteric fracture fragments. Hip fractures with comminution of the greater trochanter can be better controlled with use of the DePuy ACE Trochanteric Side Plate. By passing screws through the proximal flare, fixation of the greater trochanter and anti-rotation of the femoral head is controlled throughout the length of the plate. The DePuy ACE Trochanteric Side Plate is initially offered in 4, 6, and 8 hole configurations. The DePuy ACE Trochanteric Side Plate is manufactured from Ti-6Al-4V alloy.

The DePuy ACE Trochanteric Side Plate uses the same surgical technique for insertion as the DePuy ACE Captured Hip Screw Side Plate (which has been cleared to market by the FDA for hip fracture fixation since 1982). Both plates are manufactured from the same composition of Ti-6Al-4V; use the same Captured Hip Screw Assembly; are indicated for the same hip fractures; offer the same superior strength characteristics; are a low profile design; are inherently flexible allowing for plate conformity to the femur; and offer a proximal hole for use of 6.5mm screw.

Based on the above information, DePuy ACE Medical Company firmly believes that the new DePuy ACE Trochanteric Side Plate is substantially equivalent to the DePuy ACE Captured Hip Screw Side Plate.

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