INNOVASIVE 8MM LIGAMENT FASTENER

K970316 · Innovasive Devices, Inc. · MBI · Apr 16, 1997 · Orthopedic

Device Facts

• Record ID: K970316
• Device Name: INNOVASIVE 8MM LIGAMENT FASTENER
• Applicant: Innovasive Devices, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innovative Devices 8mm Ligament Fastener is intended for ligament to bone reattachment of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.

Device Story

Implantable tendon fixation device for ligament-to-bone repair; consists of high-density polyethylene sleeve and acetal drive pin. Deployed into pre-drilled bone hole via hex driver and inserter. Used in open or arthroscopic knee procedures by surgeons. Provides mechanical fixation via screw threads and radial compression. Benefits patient by securing ligament to bone to address recurrent instability.

Clinical Evidence

Bench testing via cadaver study comparing ultimate holding strength of subject device to predicate. Results showed equivalent holding strength at a .01 significance level.

Technological Characteristics

Materials: High-density polyethylene sleeve, acetal drive pin. Instrumentation: Stainless steel drill. Fixation: Screw threads and radial compression. Sterilization: Fastener provided sterile (single-use); instrumentation reusable (autoclavable).

Indications for Use

Indicated for patients with recurrent knee instability requiring ligament-to-bone reattachment of the Anterior or Posterior Cruciate Ligaments.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Mitek 5 mm Ligament Anchor

Submission Summary (Full Text)

{0}

APR 14 '97 16:22 FR INNOVAS.0E 308 308 075 13018274349 P.02

# 510(K) SUMMARY K970316

## 1. SUBMITTER:

Innovasive Devices, Inc. APR 16 1997
734 Forest Street
Marlboro, MA 01752
Telephone: [phone]

Contact: Eric Bannon, V.P. of Quality Assurance and Regulatory Affairs

Date Prepared: April 14, 1997

## 2. DEVICE:

Innovasive 8 mm Ligament Fastener
Classification Name: Single/multiple component bone fixation appliances and accessories.
Trade Name: Innovasive Devices Ligament Fastener

## 3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 8 mm Ligament Fastener was the Mitek 5 mm Ligament Anchor, marketed by Mitek Surgical, Norwood, MA.

## 4. DEVICE DESCRIPTIONS:

The Innovasive 8mm Ligament Fastener is an implantable tendon fixation device complete with the instrumentation needed to effect ligament to bone repair. The devices consist of a high density polyethylene sleeve with an acetal drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a hex driver, for screwing in the sleeve, and an inserter which drives the pin into the sleeve.

In addition to the Fastener, a stainless steel drill is available to establish the proper hole in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device for use in both an open and arthroscopic procedures.

{1}

APR 14 '97 16:22 FR INNOVASIVE DEVICES 300 300 070 10 13018274349 P.03

5. INTENDED USE:
The Innovative Devices 8mm Ligament Fastener is intended for ligament to bone reattachment of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.

6. COMPARISON OF CHARACTERISTICS:
The Innovative Devices 8mm Ligament Fastener is comprised of two polymer components; high density polyethylene and acetal plastic. This device is used to secure a ligament in a predrilled hole in bone. It remains fixed in the bone by the screw threads and also radial compression as the device is deployed.

The Mitek Ligament Anchor is comprised of titanium with nitinol arcs. The arcs are imbedded in the bone when placed in the predrilled hole. The intended use of the Mitek Ligament Anchor and the Innovative Ligament Fastener are identical.

7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:

1. Cadaver study: Comparison of the ultimate holding strength in the bone indicated, compared to the predicate device. The Innovative Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.