ALTA DOME AND PLUNGER (MEC HIP BOLT)

K961213 · Howmedica Corp. · KTT · Jun 13, 1996 · Orthopedic

Device Facts

• Record ID: K961213
• Device Name: ALTA DOME AND PLUNGER (MEC HIP BOLT)
• Applicant: Howmedica Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. This submission adds an additional indication for the use of this device with bone cement.

Device Story

Titanium alloy hip fracture fixation device; consists of dome and plunger components. Used for intracapsular and extracapsular (intertrochanteric) hip fractures. Procedure involves placing doughy bone cement into dome; mounting on insertion tool; inserting into femur; tightening tool to extrude cement into cancellous bone. Provides enhanced early stability; reduces risk of superior cut-out; increases load-bearing capacity. Operated by orthopedic surgeons in clinical/OR settings. Output is mechanical fixation of fracture site; aids clinical decision-making by providing stable construct for healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity and established clinical practice of bone cement augmentation in orthopedic trauma fixation.

Technological Characteristics

Titanium alloy construction; mechanical fixation device; dome and plunger geometry; utilizes bone cement for augmentation; manual insertion tool operation.

Indications for Use

Indicated for fixation of intracapsular and extracapsular (intertrochanteric) hip fractures in patients requiring fracture stabilization, including use with bone cement for enhanced early stability.

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

• Alta® Dome and Plunger (K961213)
• Howmedica Haig Nail
• Zimmer Haig Nail

Submission Summary (Full Text)

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JUN 13 1996
K96 1213

510(k) Summary

Proprietary Name: Alta® Dome and Plunger (MEC Hip Bolt)
Common Name: Hip Fracture Fixation Device
Classification Name: Single/Multiple Component Metallic Bone Fixation Appliance and Accessories
888.3030

The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. This submission adds an additional indication for the use of this device with bone cement. A small bolus of doughy bone cement is placed into the dome before it is mounted on the insertion tool. After insertion into the femur, the tool is tightened to extrude the cement into the surrounding cancellous bone. The addition of the bone cement provides enhanced early stability, reduced risk of superior cut-out and the ability to bear higher loads. The submission also describes several minor modification to the design of the device.

The substantial equivalence of this device is based on an equivalence to the previously cleared Alta® Dome and Plunger and to the use of other trauma devices for the fixation of femoral fractures with the augmentation of bone cement. Both the Howmedica Haig Nail and the Zimmer Haig Nail are indicated for use with bone cement in the stabilization of femoral fractures.

For information contact: John Dichiara
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone]
Fax: [phone]

For information contact: John Dichiara
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone]