RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM

K010633 · Mitek Products · HWC · May 9, 2001 · Orthopedic

Device Facts

• Record ID: K010633
• Device Name: RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
• Applicant: Mitek Products
• Product Code: HWC · Orthopedic
• Decision Date: May 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).

Device Story

RigidFix™ Tibial Soft Tissue ACL Crosspin System is a sterile, single-use, disposable device for tibial fixation of ACL soft tissue grafts (autograft or allograft). Constructed of bioabsorbable Poly L-lactic Acid (PLA). Used by surgeons during ACL reconstruction procedures. Device provides mechanical fixation of the graft to the tibia. Benefits include secure graft attachment to facilitate healing. No software or complex algorithms involved.

Clinical Evidence

Bench testing only. Functional and integrity bench testing and biocompatibility testing were performed in accordance with FDA guidance (ODE Blue Book Memorandum #G95-1) and ISO-10933 standards. Testing confirmed initial fixation strength for hamstring grafted ACL reconstructions.

Technological Characteristics

Constructed of bioabsorbable Poly L-lactic Acid (PLA). Sterile, single-use, disposable form factor. Mechanical fixation principle. No energy source, connectivity, or software components.

Indications for Use

Indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis) in patients undergoing ACL reconstruction.

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 - 3.3mm ST Femoral RigidFix™ Crosspin System
• Linvatec BioScrew® Absorbable Interference Screw

Submission Summary (Full Text)

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K0/063}

## ATTACHMENT H

## SUMMARY OF SAFETY & EFFECTIVENESS

Pursuant to § 13(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the proposed RigidFix™ Tibial Soft Tissue ACL Crosspin System is as follows:

| Trade Name: | RigidFix™ Tibial Soft Tissue ACL Crosspin System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Products |
| | 249 Vanderbilt Avenue |
| | Norwood, MA 02062 |
| | Registration: 1221934 |
| Device Generic Name: | Appliance for reconstruction of bone to soft tissue |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards. |
| Predicate Devices: | Mitek - 3.3mm ST Femoral RigidFix™ Crosspin System |
| | Linvatec BioScrew® Absorbable Interference Screw |

All of the devices mentioned above have been determined substantially equivalent by FDA.

Device Description: The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).

Indications for Use: The RigidFix™ Tibial Soft Tissue ACL Crosspin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts.

Safety and Performance: Functional and integrity bench testing and Biocompatibility testing to the FDA guidance document, ODE Blue Book Memoradum #G95-1, 1995, Use of International Standard ISO-10933, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed, and the data supported the substantial equivalence of the 3.3mm ST Tibial RigidFix CrossPin System. Specifically, testing was performed to determine the initial fixation strength of the Tibial RigidFix CrossPin System when used for Hamstring Grafted ACL Reconstructions

Conclusion: Based on the Indications for Use, technological characteristics and safety and performance testing, the RigidFix™ Tibial Soft Tissue ACL Crosspin System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

MAY - 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary P. LeGraw Manager, Regulatory Affairs Mitek Products 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K010633

Trade/Device Name: RigidFix Tibial ACL CrossPin System Regulation Number: 888.3040 Regulatory Class: II Product Code: HWC and MAI Dated: March 2, 2001 Received: March 2, 2001

Dear Ms. LeGraw:

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 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 - Ms. Mary P. LeGraw

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" (21CFR 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,

Buhhollerma pa

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

Enclosure

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Page __ 1__ of __ 1

510(k) Number (if known): Unknown K010633

RigidFix™ Tibial ACL CrossPin System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ammheller to Ckmu

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

510(k) Number KOI 00033