MITEK FASTIN RC ANCHOR

K983818 · Mitek Products · MBI · Nov 23, 1998 · Orthopedic

Device Facts

• Record ID: K983818
• Device Name: MITEK FASTIN RC ANCHOR
• Applicant: Mitek Products
• Product Code: MBI · Orthopedic
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The threaded Anchor holds sutures in bone for the period of time required to allow for patient rehabilitation and tissue healing.

Device Story

Threaded titanium alloy suture anchor; preloaded on disposable inserter assembly; holds two strands of #2 suture to bone. Used in surgical repair of rotator cuff. Operated by surgeon in clinical setting. Anchor provides fixation of soft tissue to bone during healing period. Benefits patient by securing tissue to facilitate rehabilitation.

Clinical Evidence

Bench testing only; mechanical tests confirm holding power equal to or greater than predicate.

Technological Characteristics

Titanium alloy; threaded anchor design; preloaded on disposable inserter; mechanical fixation principle.

Indications for Use

Indicated for rotator cuff repair.

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 FASTIN® Anchor

Submission Summary (Full Text)

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K983818

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60 GLACIER DRIVE . WESTWOOD . MA . 02090 00 GEAOIEN DHIVE - 1281778 FREE [phone] • FAX [phone]

# 510(k) SUMMARY FOR MITEK FASTIN® RC ANCHOR

### SUBMITTER

NAME ADDRESS

CONTACT

Mitek Products 60 Glacier Drive Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs October 2, 1998

### NAME OF DEVICE

TEL

DATE

| CLASSIFICATION NAME | Staple, Fixation, bone |
|---------------------|-----------------------------------------------------|
| COMMON NAME | Appliance for reconstruction of bone to soft tissue |
| PROPRIETARY NAME | Mitek FASTIN® RC Anchor |

Mitek FASTIN® Anchor PREDICATE DEVICE

The Mitek FASTIN® RC threaded titanium alloy suture anchor DESCRIPTION OF DEVICE is preloaded on a disposable inserter assembly intended for fixation of two strands of #2 suture to bone. The Mitek FASTIN® RC Anchor is designed to be used in the surgical repair of the rotator cuff.

### INTENDED USE

The threaded Anchor holds sutures in bone for the period of time required to allow for patient rehabilitation and tissue healing.

#### COMPARISON TO PREDICATE DEVICE

The Mitek FASTIN® RC is the same design as the predicate device, Mitek FASTIN®.

#### DESCRIPTION OF NON CLINICAL TESTS

Based upon mechanical tests done and contained in the literature, it can be stated that the holding power of the Mitek FASTIN® RC Anchor is equal to or greater than the Mitek FASTIN®.

## ASSESSMENT OF PERFORMANCE DATA

The Mitek FASTIN® RC is the same device as the Mitek FASTIN® which was legally cleared for marketing in March 95.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1998

Mr. Edward F. Kent Mitek Products 60 Glacier Drive Westwood, Massachusetts 02090

K983818 Re: Mitek Fastin RC Anchor Trade Name: Requlatory Class: II Product Codes: MBI, HWC, GAM, and GAS Dated: October 27, 1998 October 29, 1998 Received:

Dear Mr. Kent:

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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 In addition, FDA may publish further announcements action. 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 - Mr. Edward F. Kent

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,

Celia M. Witten, Ph.D., M.D.

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 1 of 1

510(k) Number (if known): _K9838|8

Mitek FASTIN® RC Anchor Device Name:

Rotator cuff repair Indications For Use:

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

Concurrence of CDRH , Office of Device Evaluation (ODE)

Prescription Use_ X OR

Over -The-Counter Use_________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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