MICROFIX QUICKANCHOR PLUS

K024115 · Mitek Worldwide · HWC · Mar 13, 2003 · Orthopedic

Device Facts

• Record ID: K024115
• Device Name: MICROFIX QUICKANCHOR PLUS
• Applicant: Mitek Worldwide
• Product Code: HWC · Orthopedic
• Decision Date: Mar 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MICROFIX QUICKANCHOR Plus is intended for fixation of soft tissue to bone for the indications listed below: Hand: Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal) and MCP (metacarpal interphalangeal) joints for all digits Skull: Soft tissue attachment to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and perioorbital bones of the skull.

Device Story

Bioabsorbable polymer implant for reattaching soft tissue to bone; mounted on disposable inserter assembly; placement facilitated by sterile, disposable drill bit. Used by surgeons in clinical settings. Implant secures tissue via suture; provides mechanical fixation during healing. Benefits include bioabsorbability, eliminating need for secondary removal surgery.

Clinical Evidence

No clinical data.

Technological Characteristics

Bioabsorbable polymer implant; disposable inserter assembly; sterile disposable drill bit. Mechanical fixation principle. Sterilization method utilized.

Indications for Use

Indicated for soft tissue-to-bone fixation in the hand (collateral ligaments, flexor/extensor tendons at PIP, DIP, MCP joints) and skull (parietal, temporal ridge, frontal, mandible, maxilla, zygoma, periorbital bones).

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

• MICRO Anchor
• ReSolve QuickAnchor
• BIOFASTIN RC suture anchors

Submission Summary (Full Text)

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K024115

MAR 1 3 2003

249 Vanderbilt Avenue Norwood, MA 02062 Registration #1221934 Ruth C. Forstadt Contact Person: Tel: [phone] [phone] Fax: E-mail:rforstad(@ethus.jnj.com December 2, 2002 Date Summary Prepared: MICROFIX QUICKANCHOR Plus Device Trade Name: Common name: Biodegradable Fixation Fastener Fastener, Fixation, Biodegradable Soft Tissue Classification Name: (Class II, 21 CFR 888.3030, Product code: 87 MAI) MICRO Anchor, ReSolve QuickAnchor and Predicate Device(s): BIOFASTIN RC suture anchors The MICROFIX QUICKANCHOR Plus is a Device Description: bioabsorbable polymer implant designed for reattachment of soft tissue to bone. Similar to the currently marketed MICRO Anchor, the implant is mounted on a disposable inserter assembly and placement of the implant is facilitated via use of a sterile, disposable drill bit. There have been no modifications to the drill bit for use with the MICROFIX QUICKANCHOR Plus device. Intended Use: The MICROFIX QUICKANCHOR Plus is intended for fixation of soft tissue to bone for the indications listed below: Hand: Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal) and MCP (metacarpal interphalangeal) joints for all digits

Skull: Soft tissue attachment to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and perioorbital bones of the skull.

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Kod 4115

## 510(k) Summary (page 2 of 2)

| Technological Characteristics: | The proposed device has similar technological characteristics and is similar in design and configuration compared with the predicate devices. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Non-clinical Test: | Testing conducted to characterize performance of the MICROFIX QUICKANCHOR Plus has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified. |
| Clinical Data: | Not Applicable |
| Conclusion: | Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, the MICROFIX QUICKANCHOR Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |

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MAR 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide 249 Vanderbilt Avenue Norwood, MA 02062

Re: K024115

Trade/Device Name: Mitek Microfix Quickanchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 12, 2002 Received: December 13, 2002

Dear Ms. Forstadt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ruth C. Forstadt

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mulkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known): K o 2 4/1

## Device Name: MICROFIX QUICKANCHOR Plus

The MICROFIX QUICKANCHOR Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:

Hand: Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal) and MCP (metacarpal interphalangeal) joints for all digits.

Skull: Soft tissue attachment to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and periorbital bones of the skull.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the -Counter Use No

Mark A. Milhursin
Division Sign Off

510(k) Number K024115