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 Description

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.

AI/ML Overview

This submission does not contain the information required to complete the request. The provided text describes a medical device, its intended use, contraindications, and comparisons to a predicate device, but it does not include any details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations. The document explicitly mentions "COMPLIANCE WITH PERFORMANCE STANDARDS" but states "Not applicable." Therefore, I cannot extract the requested information about device performance and the study proving it meets acceptance criteria.

Summary

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R. Thomas Grotz, M.D.

510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction

FEB -7 1997

Confidential -

K964927

510(k) SUMMARY

SUBMITTED BY:

R. Thomas Grotz, M.D. 530 Bush Street, 10th Floor San Francisco, California 94108 Telephone: (415) 398-2332 (415) 398-2614 Fax:

Date Submitted: December 6, 1996

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

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

PREDICATE DEVICE

Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc.

DEVICE DESCRIPTION

INDICATIONS FOR USE:

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510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction

Confidential -

1 7 6 4 9 2

CONTRAINDICATIONS. WARNINGS, PRECAUTIONS AND COMPLI-CATIONS

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.
Warnings 2.
- The Stabilizer Soft Tissue Anchor is intended to assist in the 2.1 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 pullout from the bone. In some cases, revisions may require explant of the bone anchor.
- The drill is stainless steel. To assure proper bone cutting 2.2 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.
1. 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.

Complications 4.
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.

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R. Thomas Grotz, M.D.

510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor
for ACL RepairReconstruction

Confidential -

1904-727

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.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.