MITEK 2GII MENISCAL REPAIR SYSTEM

K002406 · Mitek Products · MAI · Feb 15, 2001 · Orthopedic

Device Facts

• Record ID: K002406
• Device Name: MITEK 2GII MENISCAL REPAIR SYSTEM
• Applicant: Mitek Products
• Product Code: MAI · Orthopedic
• Decision Date: Feb 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).

Device Story

Mitek RapidLoc™ Meniscal Repair System is a sterile, two-part biodegradable fastener consisting of a molded PLA Backstop and Tophat. Used in arthroscopic surgery for fixation of longitudinal vertical meniscus lesions (bucket-handle tears) in vascularized zones. Device functions as a mechanical fastener to stabilize meniscal tissue during healing. Operated by orthopedic surgeons in an arthroscopic setting. Provides secure fixation of meniscal tissue, potentially improving healing outcomes for patients with specific meniscal tears.

Clinical Evidence

Bench testing only. Performance data provided includes strength comparison testing against the Mitek "H" Fix and suture comparison testing against PDS Suture.

Technological Characteristics

Biodegradable fastener system composed of molded PLA (polylactic acid). Two-part design consisting of a Backstop and Tophat. Sterile, single-use device for arthroscopic fixation.

Indications for Use

Indicated for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) in the vascularized (red-red and red-white) zones of the meniscus.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Mitek "H" Fix (K970119)
• PDS Absorbable Suture (NDA#18-331)

Submission Summary (Full Text)

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K02406

# FEB 1 5 2001

## 510(k) Summary

| Trade Name: | Mitek RapidLoc™ Meniscal Repair System |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Products |
| | 249 Vanderbilt Avenue |
| | Norwood, MA 02062 |
| | Registration #1221934 |
| Contact: | Christine Kuntz-Nassif |
| | Sr. Regulatory Affairs Associate |
| | Telephone: [phone] |
| | Fax: [phone] |
| Device Generic Name: | Fastener Fixation, Biodegradable, Soft Tissue |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Product Code: | 87 MAI |
| Predicate Devices: | K970119 - Mitek "H" Fix; NDA#18-331 - PDS Absorbable Suture |

Product Description: The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.

#### Indications for Use:

The RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal wertical meniscus lesions (bucket-handle lesions) located in the vasularized area of the meniscus (red-red and red-white zones).

## Safety and Performance:

Safety and Performance data has been provided to support subtantial equivalence of the Mitek RapidLoc TM Meniscal Repair System:

Performance Testing:

- ormance Testing.
Strength comparison (RapidLoc™ Meniscal Repair System vs. Mitek "H" Fix) .
- Sucurem Compurison (RapidLoc™ Meniscal Repair System vs. PDS Suture) ●

## Conclusion:

Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principle, biocompatibility and Based on 1) safety and periornalice uala, and 27 simminted in dosign opening production in the substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 5 2001

Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek Products 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K002406

Trade Name: Rapidloc™Meniscal Repair System Regulatory Class: II Product Code: MAI, GAS and GAM Dated: November 16, 2000 Received: November 17, 2000

Dear Ms. Kuntz-Nassif:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Security from hoursentially equivalent (for the indications for use above and we nave determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasure) to device Amendments, or to devices that have been reclassified in enacultient date of the Medical Dories Fanenal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the rockers of the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices in controls provisions of the rect menuse required in the mastranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see acc very a to such additional controls. Existing major regulations (Frenaries Approval), it they of subject to outs f Federal Regulations, Title 21, Parts 800 to 895. atrecting your do rios can determination assumes compliance with the current Good A substantially equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requirement, as s c CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to Inspections, the Pood and Drug Administration. In addition, FDA may publish Comply with the GMT regarating your device in the Federal Register. Please note: this fultities alliouncentions concerning your submission does not affect any obligation you might It sponse to your promation in 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) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Christine Kuntz-Nassif

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for this diagnestions on the promotion and advertising of your device, (2011) 594-4639. prease connact the Orive or Somphares en premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnies and its into into internation of at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark Mckisson

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 1

510(k) Number (if known): K002406

Device Name: Mitek RapidLoc™ Meniscal Repair System

Indications for Use:

The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).

Mark A. Milkersen

Division Sign-Off) (Division Sign-Off)
Division of General, Restorative Division of General Devices Division of Ochoral
And Neurological Devices and Neurological Devices KOO2406

510(k) Number -