RESOLVE QUICKANCHOR

K993575 · Mitek Products · DZL · Dec 29, 1999 · Dental

Device Facts

• Record ID: K993575
• Device Name: RESOLVE QUICKANCHOR
• Applicant: Mitek Products
• Product Code: DZL · Dental
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ReSolve™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications: Cranio/Maxillofacial: Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.

Device Story

Sterile bone fixation implant; anchors or locks suture within pre-drilled bone sites; secures soft tissue to bone. Used in cranio/maxillofacial surgery; operated by surgeons. Device provides mechanical fixation of suture to bone, facilitating tissue reattachment. Benefits include stable soft tissue repair to skull bones.

Clinical Evidence

Bench testing only. Performance data includes pullout force testing using preserved human cadaver skulls and strength comparisons against the Mitek Micro Anchor, alongside skull thickness measurements.

Technological Characteristics

Sterile bone anchor implant. Mechanical fixation principle. Materials and sterilization methods are consistent with predicate Mitek anchors. No software or electronic components.

Indications for Use

Indicated for fixation of absorbable monofilament polydioxanone surgical suture to bone for repair, reconstruction, or reattachment of tendons, ligaments, muscles, and soft tissue flaps to parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and periorbital bones of the skull.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Mitek Panalok Anchor (K970896)
• Mitek Micro Anchor (K962511)
• Mitek Micro Anchor (K982420)
• Mitek Rotator Cuff QuickAnchor Plus (K992611)

Submission Summary (Full Text)

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DEC 2 9 1999

Mitek Products ReSolve™ QuickAnchor® Cranio/Maxillofacial

Image /page/0/Picture/2 description: The image shows a handwritten text string that appears to be a code or identifier. The string is "K993575" with a horizontal line above the last digit. The text is written in a cursive style, and the image is a close-up of the text.

510(k) Premarket Notification October 20, 1999

| Trade Name: | ReSolve™ QuickAnchor |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Products |
| | 60 Glacier Drive |
| | Westwood, MA 02090 |
| | Registration #1221934 |
| Contact: | Paula E. Bulger |
| | Regulatory Affairs Project Manager |
| | Mitek Products |
| | 60 Glacier Drive |
| | Westwood, MA 02090 |
| | Phone: [phone] |
| | Fax: [phone] |
| Device Generic Name: | Staple, Fixation, Bone |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. |
| Product Code: | JDR (21 CFR 888.3030) |
| Predicate Devices: | K970896 - Mitek Panalok Anchor |
| | K962511, K982420 - Mitek Micro Anchor |
| | K992611 - Mitek Rotator Cuff QuickAnchor Plus |

Product Description: The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.

## Indications for Use:

The ReSolve™ QuickAnchor is used for the fixation of absorbable monofilament surgical suture to bone. This product is intended for the following indications:

Cranio/Maxillofacial:

Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.

## Safety and Performance:

The following safety and performance data has been provided to support substantial equivalence of ReSolve™ QuickAnchor:

| Performance testing: | Pullout force (preserved human cadaver skull) |
|----------------------|-----------------------------------------------------|
| | Strength comparison (ReSolve vs. Mitek Micro Anchor |
| | Skull thickness measurements |

## Conclusion:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Ms. Paula E. Bulger Requlatory Affairs Project Manager Mitek Products Ethicon, Inc. 60 Glacier Drive Westwood, MA 02090

K993575 Re : Resolve™ QuickAnchor (Cranio/Maxillofacial) Trade Name: Regulatory Class: II Product Code: DZL October 20, 1999 Dated: Received: October 21, 1999

Dear Ms. Bulger:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Ms. Bulger

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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sit with puivalence of your device to a legally marketed predicate device results in a classification for your markets processor mits 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,

Gerald W. Sheppan

for Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification October 20, 1999

Page 1 of of

510(k) Number (if known): K993575

Device Name: ReSolve™ QuickAnchor

Indications for Use:

The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:

Cranio/Maxillofacial:

Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps 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

(Division Sign-Off) 4 and Division of Dental, Infection and General Hospital Devic 510(k) Number_K993

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