METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

K963700 · Metagen, LLC · HRS · Feb 12, 1997 · Orthopedic

Device Facts

• Record ID: K963700
• Device Name: METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM
• Applicant: Metagen, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Feb 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies. Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.

Device Story

Fracture fixation system for closing wedge osteotomies; components include L-plates, cortical/cancellous bone screws, and offset staples. Provides immediate stability and temporary fixation during bone healing. Used in surgical settings by orthopedic surgeons. Output is mechanical stabilization of bone segments; facilitates natural healing process.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: CoCrMo (cast or wrought), Ti-6Al-4V, and 316 LVM stainless steel per ASTM standards. Mechanical fixation system consisting of plates, screws, and staples.

Indications for Use

Indicated for young, active patients with painful unicompartmental osteoarthritis (varus deformity ≤11°), rheumatoid arthritis, or trauma-related deformity requiring fixation of proximal/distal long bone fractures or stabilization following osteotomy.

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

• NexGen Osteotomy System (Zimmer)
• Natural Knee Family High Tibial Osteotomy System (Intermedics Orthopedics)
• High Tibial Osteotomy System (Richards)
• L-buttress, T-buttress and T-plates (Synthes)
• ECT Internal Fracture Fixation System (Zimmer)
• Improved Geibel Blade Plates (Link America Inc.)
• Osteo Auto-Compression Plating System (Smith & Nephew Richards)
• May Anatomical Bone Plates (Waldemar Link)

Submission Summary (Full Text)

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K963700
Summary of Safety and Effectiveness for
FEB 12 1997

# Metagen High Tibial Osteotomy System

This safety and effectiveness summary for the Metagen High Tibial Osteotomy System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

## 1. Submitter:

Metagen, LLC
Origen Center
428 Technology Drive East
Menomonie, Wisconsin 54751

## Contact Person:

Wesley Johnson
Metagen, LLC
Origen Center
428 Technology Drive East
Menomonie, Wisconsin 54751
Telephone: [phone]

Date Prepared: September 9, 1996

## 2. Trade Name:

Metagen High Tibial Osteotomy System

Common Name: Fracture Fixation System

Classification Name: Single/ multiple component metallic bone fixation appliances and accessories (888.3030)

## 3. Predicate or legally marketed devices which are substantially equivalent:

- NexGen Osteotomy System ( Zimmer )
- Natural Knee Family High Tibial Osteotomy System ( Intermedics Orthopedics )
- High Tibial Osteotomy System ( Richards )
- L-buttress, T-buttress and T-plates ( Synthes )
- ECT Internal Fracture Fixation System ( Zimmer )
- Improved Geibel Blade Plates ( Link America Inc. )
- Osteo Auto-Compression Plating System ( Smith & Nephew Richards )
- May Anatomical Bone Plates ( Waldemar Link )

## 4. Description of the device:

The High Tibial Osteotomy System is a fracture fixation system used to perform closing wedge osteotomies. It consists of L-plates, cortical and cancellous bone screws, and offset staples.

**Materials:** The devices are manufactured from CoCrMo ( cast or Wrought ), Ti-6Al-4V, and 316 LVM stainless steel per ASTM standards.

**Function:** The system functions to provide immediate stability and temporary fixation during the natural healing process following osteotomy.

## 5. Intended Use:

The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies.

Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.

## 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

There are no significant differences between the Metagen High Tibial Osteotomy System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.