INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER

K954338 · Innovasive Devices, Inc. · MBI · Mar 21, 1996 · Orthopedic

Device Facts

• Record ID: K954338
• Device Name: INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
• Applicant: Innovasive Devices, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 21, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innovative Devices 1.9mm ROC Suture Bone Fastener is intended for the reattachment of the ulnar collateral and lateral collateral ligaments in the thumb and the scapholunate ligament in the wrist.

Device Story

Implantable soft tissue fixation device; used for reattaching ligaments to bone. System includes high-density polyethylene cartridge, acetal drive pin, and stainless steel drive tool. Deployed via molded polysulfone handle into pre-drilled bone hole; radial compression secures implant. Instrumentation includes stainless steel drill, drill guide, and extractor. Used by surgeons in open or arthroscopic procedures. Provides mechanical fixation of suture to bone; facilitates soft tissue-to-bone repair; enables ligament reattachment.

Clinical Evidence

Bench testing via cadaver study; compared ultimate holding strength of subject device to predicate. Results indicated equivalent holding strength.

Technological Characteristics

Materials: high-density polyethylene, acetal plastic, stainless steel, polysulfone. Principle: radial compression fixation in pre-drilled bone hole. Form factor: 1.9mm fastener with deployment instrumentation. Sterilization: sterile, single-use fastener; reusable, autoclavable instrumentation.

Indications for Use

Indicated for patients requiring reattachment of ulnar collateral and lateral collateral ligaments in the thumb and scapholunate ligament in the wrist.

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

• Ethicon USP #2/0 braided polyester suture with suture button

Submission Summary (Full Text)

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510(k) SUMMARY
R95433B
MAR 21 1996

1. SUBMITTER:

Innovasive Devices, Inc.
100B South St.
Hopkinton, MA 01748
Telephone: [phone]

Contact: Eric Bannon, Director of Quality Assurance and Regulatory Affairs
Date Prepared: August 29, 1995

2. DEVICE:

Innovasive 1.9mm ROC Suture Bone Fastener
Classification Name: Single/multiple component bone fixation appliances and accessories.
Trade Name: Innovasive Devices ROC Suture Bone Fastener

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 1.9mm Roc Suture Bone Fastener was Ethicon USP #2/0 braided polyester suture with suture button.

4. DEVICE DESCRIPTIONS:

The Innovasive ROC Suture Bone Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a high density polyethylene cartridge 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 deployment handle made of molded polysulfone. The Fastener also has a stainless steel drive tool inside the cartridge which shears the implantable Fastener when deployed by the handle. The Fastener comes with various non-absorbable suture material.

In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole for in the bone for the Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener should it be necessary. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

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# 5. INTENDED USE:

The Innovative Devices 1.9mm ROC Suture Bone Fastener is intended for the reattachment of the ulnar collateral and lateral collateral ligaments in the thumb and the scapholunate ligament in the wrist.

# 6. COMPARISON OF CHARACTERISTICS:

The Innovative Devices ROC Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.

The Ethicon suture is comprised of braided polyester fibers and the suture button is comprised of molded polypropylene. The devices are used in conjunction with each other to reattach soft tissue to bone. The suture is passed through the bone and tissue and fixed with a suture button. This approximates the tissue to the bone to allow the final repair.

# 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 Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.