INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER

K963402 · Innovasive Devices, Inc. · MBI · Nov 4, 1996 · Orthopedic

Device Facts

• Record ID: K963402
• Device Name: INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
• Applicant: Innovasive Devices, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Story

Implantable soft tissue fixation device; secures suture to bone for bladder neck suspension. Input: pre-drilled bone hole. Operation: high-density polyethylene cartridge with acetyl drive pin deployed via polysulfone handle; stainless steel drive tool shears fastener upon deployment; radial compression secures device in bone. Output: fixed suture anchor. Used in clinical setting by surgeons. Benefits: enables soft tissue-to-bone repair for incontinence treatment.

Clinical Evidence

Bench testing and cadaver study performed. Cadaver study compared ultimate holding strength of subject device versus predicate; results demonstrated equivalence at .01 significance level.

Technological Characteristics

Materials: high-density polyethylene, acetyl plastic, stainless steel, polysulfone. Fixation: radial compression in pre-drilled bone hole. Form factor: 2.8mm and 3.5mm sizes. Sterilization: sterile, single-use fastener; reusable instrumentation (autoclavable).

Indications for Use

Indicated for female patients with urinary incontinence due to urethral hypermobility requiring bladder neck suspension.

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 GII Anchor (K963402)

Submission Summary (Full Text)

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NOV 4 1996
510(k) SUMMARY
K963402

# 1. SUBMITTER:

Innovasive Devices, Inc.
734 Forest St.
Marlborough, MA 01752
Telephone: [phone]

Contact: Eric Bannon, Vice President of Quality Assurance and Regulatory Affairs
Date Prepared: August 25, 1996

# 2. DEVICE:

Innovasive 2.8mm and 3.5mm 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 2.8mm and 3.5mm Roc Suture Bone Fastener was the Mitek GII Anchor, marketed by Mitek Surgical, Norwood, MA.

# 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 acetyl 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.

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The Fastener will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.

## 5. INTENDED USE:

The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

## 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 Mitek Mini Anchor is comprised of titanium with nitinol arcs. The arcs are imbedded in bone when placed in the predrilled hole. The intended use of the Mitek GII Anchor and the Innovative ROC Fasteners 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 Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.