INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER

K970089 · Innovasive Devices, Inc. · MBI · Mar 25, 1997 · Orthopedic

Device Facts

• Record ID: K970089
• Device Name: INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
• Applicant: Innovasive Devices, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER 1. Repair of rotator cuff tears 2. capsular instability 3. slap lesion repair 4. acromio-clavicular separation 5. capsule shift/capsulolabral reconstruction 6. biceps tenodesis 7. deltoid repair KNEE 1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure. 2. Patellar ligament and tendon avulsion repairs. 3. Extra-capsular reconstruction, ITB tenodesis ANKLE 1. Lateral instability 2. Medial instability 3. Achilles tendon reconstruction and repair 4. Mid-foot reconstructions FOOT 1. Hallux valgus reconstruction BLADDER NECK SUSPENSION 1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Story

Bone fixation implant for soft tissue reattachment. Consists of shear pin, expander, and sleeve. Deployment: shear pin pulled, drawing tapered expander into sleeve; sleeve expands to contact bone; pin shears off, leaving fastener fixed in predrilled hole. Used in open or arthroscopic surgery by orthopedic surgeons. Instrumentation includes stainless steel drill, drill guide, obturator, deployment handle, and hole finder. Provides mechanical fixation of soft tissue to bone; benefits include secure reattachment during reconstructive procedures.

Clinical Evidence

Bench testing only. Comparison of ultimate holding strength in cadaveric humeral head/glenoid and synthetic bone models showed the ROC LF Suture Bone Fastener is equivalent to the predicate device.

Technological Characteristics

Materials: high density polyethylene and acetyl plastic. Mechanism: mechanical expansion via shear pin/expander/sleeve assembly. Form factor: 2.8mm and 3.5mm diameters. Sterile, single-use implant. Reusable stainless steel instrumentation (drill, guide, obturator, handle). Sterilization: autoclaving for reusable instruments.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder, knee, ankle, and foot procedures, and for bladder neck suspension in females with urethral hypermobility-related urinary incontinence.

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

• Innovasive Devices ROC Suture Bone Fastener

Submission Summary (Full Text)

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MAR 25 1997
K970089
510(K) SUMMARY

## 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: December 16, 1996

## 2. DEVICE:

Innovasive 2.8mm and 3.5mm ROC LF Suture Bone Fastener
Classification Name: Single/multiple component bone fixation appliances and accessories.
Trade Name: Innovasive Devices ROC LF Suture Bone Fastener

## 3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 2.8mm and 3.5mm Roc LF Suture Bone Fastener was the Innovasive Devices ROC Suture Bone Fastener, marketed by Innovasive Devices, Marlborough, MA.

## 4. DEVICE DESCRIPTIONS:

The ROC LF suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.

In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener

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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.

## 5. INTENDED USE:

The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

### SHOULDER

1. Repair of rotator cuff tears
2. capsular instability
3. slap lesion repair
4. acromio-clavicular separation
5. capsule shift/capsulolabral reconstruction
6. biceps tenodesis
7. deltoid repair

### KNEE

1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.
2. Patellar ligament and tendon avulsion repairs.
3. Extra-capsular reconstruction, ITB tenodesis

### ANKLE

1. Lateral instability
2. Medial instability
3. Achilles tendon reconstruction and repair
4. Mid-foot reconstructions

### FOOT

1. Hallux valgus reconstruction

### BLADDER NECK SUSPENSION

1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

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# 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 ROC LF device consists of similar materials as the ROC fastener. It uses an expander fitted on a shear pin which is drawn up into an expanable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site.

# 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 humeral head and gleniod compared to the predicate device. The Innovative ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.

2. Bone model testing: Comparison of the ultimate holding strength in the bone model compared to the predicate device. The Innovative ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.