STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8

K964927 · R. Thomas Grotz, M.D., Inc. · MBI · Feb 7, 1997 · Orthopedic

Device Facts

• Record ID: K964927
• Device Name: STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
• Applicant: R. Thomas Grotz, M.D., Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Feb 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.

Device Story

Stabilizer Soft Tissue Anchor is a 316L stainless steel implant for ACL repair/reconstruction. Used by surgeons to attach soft tissue to bone. Procedure involves drilling a hole in bone, inserting the anchor, and expanding internal teeth via an anchor inserter to secure the device. Three sutures are used to attach the ACL to the anchor. An included crimper secures the suture to the anchor. Device provides mechanical fixation; clinical benefit is stabilization of soft tissue during healing. Used in surgical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: 316L stainless steel. Principle: Mechanical bone fixation via expandable teeth. Components: 8 mm anchor, drill, anchor inserter, crimper. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring ACL repair or reconstruction. Contraindicated in patients with severe osteopenia, cystic bone degeneration, comminuted bone, compromised bone/soft tissue, infection, osteonecrosis, bone disease, or known stainless steel allergies.

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 Ligament Anchor

Submission Summary (Full Text)

{0}

510(k) Premarket Notification
Stabilizer™ Soft Tissue Anchor
for ACL Repair/Reconstruction
R. Thomas Grotz, M.D.
FEB - 7 1997
- Confidential -
K944927

# 510(k) SUMMARY

## SUBMITTED BY:

R. Thomas Grotz, M.D.
530 Bush Street, 10th Floor
San Francisco, California 94108
Telephone: [phone]
Fax: [phone]

Date Submitted: December 6, 1996

## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Fastener, fixation, nondegradable, soft tissue
Common/Usual Name: Soft Tissue Anchor
Proprietary Name: Stabilizer™ Soft Tissue Anchor, 8 mm

## PREDICATE DEVICE

Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc.

## DEVICE DESCRIPTION

The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.

Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and securing the ACL to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole.

## INDICATIONS FOR USE:

The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.

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{1}

510(k) Premarket Notification
Stabilizer™ Soft Tissue Anchor
for ACL Repair/Reconstruction
R. Thomas Grotz, M.D.
- Confidential -

# CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLICATIONS

## 1. Contraindications

The Stabilizer Soft Tissue Anchor is contraindicated in the presence of pathological conditions such as severe osteopenia, cystic degeneration, or comminution of bone which would compromise fixation. The Stabilizer should not be used in compromised bone or in the presence of pathological soft tissue conditions which would compromise fixation. It should also not be used in the presence of pathophysiological conditions such as infection, osteonecrosis, or bone disease. The product should not be used in patients with known allergies to stainless steel.

## 2. Warnings

2.1 The Stabilizer Soft Tissue Anchor is intended to assist in the fixation of soft tissue to bone. Each case should be carefully analyzed to assure that the anchor and suture are appropriate to support the repair/reconstruction. Excessive tension on the suture or anchor may result in suture breakage or implant pull-out from the bone. In some cases, revisions may require explant of the bone anchor.

2.2 The drill is stainless steel. To assure proper bone cutting characteristics, the drill should be replaced after every 10 uses. If the drill should break during use, remnants should be removed from the surgical site prior to proceeding.

## 3. Precautions

The Stabilizer Soft Tissue Anchor is intended for use by surgeons familiar with soft tissue and bone attachment techniques. The patient must be cautioned against early weightbearing and/or premature ambulation as this could lead to loosening or failure of the implant or suture attachments. Standard postoperative practices for the treatment and rehabilitation of repaired joints must be followed.

## 4. Complications

Potential complications with the The Stabilizer Soft Tissue Anchor include, but are not limited to, the following: infection, osteomyelitis, suture breakage, implant breakage, implant pull-out, reoperation, revision or explant.

{2}

510(k) Premarket Notification
Stabilizer™ Soft Tissue Anchor
for ACL Repair/Reconstruction
R. Thomas Grotz, M.D.
- Confidential -

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The product design, material of construction, and function as a soft tissue anchor is substantially equivalent to the FDA cleared predicate device.

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