← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K963217

# ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM (K963217)

_Wrightmedicaltechnologyinc · MBI · Oct 2, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K963217

## Device Facts

- **Applicant:** Wrightmedicaltechnologyinc
- **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md)
- **Decision Date:** Oct 2, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following: - repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a SLAP lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; - repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; - repair of foot/ankle instability secondary to foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments

## Device Story

Single-use sterile kit; includes titanium alloy bone anchor, disposable wire leader, and protective sleeve. Surgeon-operated in clinical/surgical settings. Device provides mechanical fixation for soft tissue-to-bone repair; surgeon threads preferred suture through anchor. Facilitates stabilization of ligaments and tendons across multiple joints; aids healing by securing tissue to bone.

## Clinical Evidence

Bench testing only. 7.5mm and 2.5mm anchors tested per Draft Guidance Document for Testing Bone Anchor Devices (April 1, 1993). Results indicate performance meets or exceeds in vivo performance of predicate 5.0mm anchor and USP standards for Nylon™ monofilament sutures.

## Technological Characteristics

Titanium alloy bone anchor; disposable wire leader; disposable protective sleeve. Single-use, sterile. Mechanical fixation device. No software or electronic components.

## Regulatory 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

- ANCHORLOK™ Polyester Suture Soft Tissue Anchor System

## Submission Summary (Full Text)

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SEP-30-96 12:44 FROM:WRIGHT MEDICAL CR AFFAIRS
PAGE 4/7

WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971

OCT - 2 1996
K963217

510(k) Summary

Contact Person: Cristie Manuel
Date Prepared: September 30, 1996

Trade/Proprietary Name: ANCHORLOK™ II Soft Tissue Anchor System
Common Name: Fastener, fixation, nondegradable, soft tissue
Product Classification: Class II
Predicate Device: ANCHORLOK™ Polyester Suture Soft Tissue Anchor System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Description/Intended Use
The ANCHORLOK™ II Soft Tissue Anchor System is a single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve. The surgeon uses suture according to preference. The anchor is manufactured from titanium alloy.

The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following:

- repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a SLAP lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments

Testing Summary
The 7.5mm anchor was tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor.

The 2.5mm and 7.5mm ANCHORLOK™ II Soft Tissue Anchors were tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the in vivo performance of Nylon™ monofilament sutures meets or exceeds the values established by USP for these devices.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K963217](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K963217)

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