ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM

K971282 · Wrightmedicaltechnologyinc · MBI · Jun 27, 1997 · Orthopedic

Device Facts

• Record ID: K971282
• Device Name: ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBI · Orthopedic
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use: - In the 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; - In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - Female urinary incontinence due to urethral hypermobility; - In the 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; - In the 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; - Lateral canthoplasty.

Device Story

Titanium alloy soft tissue anchor system; used for orthopedic and reconstructive surgical fixation. Two configurations: ANCHORLOK™ (preloaded with suture, disposable driver) and ANCHORLOK™ RL (reusable driver, surgeon-provided suture). Operated by surgeons in clinical/OR settings. Anchors inserted into bone to secure soft tissue (tendons/ligaments) to facilitate healing. Benefit: provides mechanical fixation for tissue repair. Output is physical stabilization of soft tissue.

Clinical Evidence

Bench testing only. In vitro pullout strength testing performed to compare ANCHORLOK™ RL anchor performance against predicate Mitek anchor.

Technological Characteristics

Materials: Titanium alloy. Form factor: Soft tissue anchor system. Configurations: Single-use sterile with disposable driver or sterile with reusable driver. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation for repair of instability or tears in shoulder, elbow, hand/wrist, knee, and foot/ankle joints, as well as for female urinary incontinence due to urethral hypermobility and lateral canthoplasty.

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

• ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System (manufactured for Wright Medical Technology, Inc.)
• Mitek Anchor (Mitek Surgical Products, Inc.)

Submission Summary (Full Text)

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K971282
JUN 27 1997

# 510(k) Summary

Contact Person: Cristie Manuel
Date Prepared: April 4, 1997

Trade/Proprietary Name: ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System
Classification Name: Fastener, fixation, nondegradable, soft tissue
Predicate Device: ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System manufactured for Wright Medical Technology, Inc., and the Mitek Anchor manufactured by Mitek Surgical Products, Inc.

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™ and ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile device, available in two configurations: the ANCHORLOK™, which is provided sterile, preloaded with suture and a disposable, single use driver, and the ANCHORLOK™ RL, which is provided sterile and is designed for use with reusable, resterilizable driver instrumentation, and suture provided by the surgeon. The anchors for both configurations are made of titanium alloy.

The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:

- In the 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;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- Female urinary incontinence due to urethral hypermobility;
- In the 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;
- In the 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;
- Lateral canthoplasty.

## Testing Summary

Conclusion: In vitro pullout strength testing indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Mitek anchor.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Christie Manuel
*Regulatory Affairs Associate
Wright Medical Technology, Inc.
5677 Airline Road
Arlington, Tennessee 38002

Re: K971282
Anchorlok and Anchorlok RL
Soft Tissue Anchor System
Regulatory Class: II
Product Codes: MBI and HWC
Dated: April 4, 1997
Received: April 7, 1997

Dear Ms. Manuel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Christie Manuel

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Maria A. Schroeder, MS, PT
for Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Wright Medical Technology, Inc.
Premarket Notification
ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System, Expanded Indication

## C. Indications for Use of the Device

510(k) Number (if known): K971282

Device Name: ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System

## Indications for Use:

The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:

- In the 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;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- Female urinary incontinence due to urethral hypermobility;
- In the 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;
- In the 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;
- Lateral canthoplasty

(Please do not write below this line—continue on another page if needed)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mauri A. Chocolat, M.S.P.T. for C.M.W.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971282

Prescription Use ☑
(Per 21 CFR 801.109)

Or

Over-the-Counter Use ☐
(Optional Format 1-2-96)

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