MITEK MINI QUICKANCHOR PLUS

K992487 · Mitek Products · HWC · Sep 21, 1999 · Orthopedic

Device Facts

• Record ID: K992487
• Device Name: MITEK MINI QUICKANCHOR PLUS
• Applicant: Mitek Products
• Product Code: HWC · Orthopedic
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek Mini QuickAnchor® Plus is indicated for: shoulder (Bankart repair) ankle (Mid-foot reconstruction) foot (Hallux valgus reconstruction) hand (Ulnar or lateral collateral ligament reconstruction) wrist (Scapholunate ligament reconstruction) pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).

Device Story

Sterile, disposable bone anchor system; titanium alloy shaft with nickel-titanium shape-memory alloy arcs; pre-loaded on disposable inserter with polyester suture. Used by surgeons in clinical/OR settings for soft tissue-to-bone fixation. Device functions as mechanical fastener; surgeon inserts anchor into bone to secure sutures for ligament/tendon repair or bladder neck suspension. Benefits include simplified delivery via pre-loaded inserter, reducing procedural steps. Output is physical fixation of soft tissue to bone.

Clinical Evidence

Bench testing only. Performance data provided for insertion force, pull-out force, suture hole interface, and off-axis insertion to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Bone fixation fastener; titanium alloy shaft; nickel-titanium shape-memory alloy arcs; polyester suture; supplied sterile, disposable; pre-loaded on inserter.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder (Bankart repair), ankle (mid-foot reconstruction), foot (hallux valgus reconstruction), hand (ulnar/lateral collateral ligament reconstruction), wrist (scapholunate ligament reconstruction), and pubis (stress urinary incontinence due to urethral/bladder neck hypermobility).

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 GII Mini QuickAnchor (K921873)
• Mitek Mini Anchor (K930892)
• Mitek Mini Anchor (K936311)

Submission Summary (Full Text)

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Mitek® Products

Mini QuickAnchor® Plus

510(k) Premarket Notification July 23, 1999

K992487

# 510(k) Summary

Mitek Mini QuickAnchor® Plus Trade Name: Sponsor: Mitek Products 60 Glacier Drive Westwood, MA 02090 Registration #1221934 Christine Kuntz-Nassif Contact: Telephone: [phone] Fax: [phone] Smooth or threaded metallic bone fixation fastener Device Generic Name: According to Section 513 of the Federal Food, Drug, and Classification: Cosmetic Act, the device classification is Class II. HWC (21 CFR 888.3040) Product Code: K921873 - Mitek GII Mini QuickAnchor Predicate Devices: K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor

Product Description: The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded on an inserter with a polyester suture.

### Indications for Use:

Mitek Mini Anchors have been found substantially equivalent in previous Premarket Notifications for the following indications:

| Shoulder: | Bankart Repair |
|-----------|------------------------------------------------------------------------------------------|
| Ankle: | Midfoot Reconstructions |
| Foot: | Hallux Valgus Reconstruction |
| Wrist: | Scapholunate Ligament Reconstruction |
| Hand: | Ulnar or Lateral Collateral Ligament Reconstruction |
| Pubis: | Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence |

This current 510(k) allows modification of the Mini Anchor design in order to accommodate the line extension which includes the Mini QuickAnchor® Plus, providing a pre-loaded single use anchor on a disposable inserter.

#### Safety and Performance:

The following safety and performance data has been provided to support substantial equivalence of the Mini Anchor for the design modification:

Insertion force, PullOut force, Suture Hole interface and Off-axis insertion. Performance testing:

#### Conclusion:

Based on 1) safety and performance data, and 2) similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Mini QuickAnchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.

#### SEP 2 1 19999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek Products 60 Glacier Dr. Westwood, Massachusetts 02090

Re: K992487

Trade Name: Mitek Mini QuickAnchor® Plus Regulatory Class:II Product Code: HWC Dated: July 23, 1999 Received: July 26, 1999

Dear Ms. Kuntz-Nassif:

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 legally marketed predicate 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 requirements, 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 vou 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. Christine Kuntz-Nassif

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/dsma/dsmamain.html".

Sincerely yours,

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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Page . of

510(k) Number (if known):长ብዓ 24 ۶ 7

Device Name: __ Mitek Mini QuickAnchor® Plus

Indications for Use:

The Mitek Mini QuickAnchor® Plus is indicated for:

shoulder (Bankart repair) ankle (Mid-foot reconstruction) foot (Hallux valgus reconstruction) hand (Ulnar or lateral collateral ligament reconstruction) wrist (Scapholunate ligament reconstruction) pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-the-Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | K992487 |
|---------------|---------|
|---------------|---------|

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