RIDIDFIX 2.7MM BTB CROSS PIN KIT

K013781 · Mitek Products · HTY · Feb 6, 2002 · Orthopedic

Device Facts

• Record ID: K013781
• Device Name: RIDIDFIX 2.7MM BTB CROSS PIN KIT
• Applicant: Mitek Products
• Product Code: HTY · Orthopedic
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RigidFix 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixations for autograft or allograft ACL bone-tendon-bone grafts.

Device Story

RigidFix 2.7mm BTB Cross Pin Kit is a sterile, single-use, disposable surgical device; used for femoral and tibial fixation of bone-tendon-bone (BTB) grafts during ACL reconstruction. Device consists of bioabsorbable Poly Lactic Acid (PLA) cross pins. Operated by surgeons in an OR setting. Provides mechanical fixation of graft to bone; facilitates healing by securing graft in place. Benefits patient by providing stable fixation for ACL reconstruction.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included functional and integrity bench testing and biocompatibility evaluation per ISO 10993-1 and FDA Memorandum #G95-1 to confirm initial fixation strength.

Technological Characteristics

Materials: Bioabsorbable Poly Lactic Acid (PLA). Form factor: Cross pin kit for bone-to-soft tissue reconstruction. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts in patients requiring 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 - RigidFix™ 2.7mm BTB Cross Pin Kit (K974291)
• Linvatec BioScrew® Absorbable Interference Screw (K973758)

Submission Summary (Full Text)

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## ATTACHMENT H

K013781

## FEB 0 6 2002

## SUMMARY OF SAFETY & EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is requires assets and r ulsulant to 915(1)(3)(1) or the Food, 27th, adequate summary of any information respecting safety and this Frenarket Northeaton will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to \$13(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™ 2.7mm BTB Cross Pin Kit is as follows:

| Trade Name: | RigidFix™ 2.7mm BTB Cross Pin Kit |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Products<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>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<br>device classification is Class II, Performance Standards. |
| Predicate Devices: | Mitek - RigidFix™ 2.7mm BTB Cross Pin Kit (K974291)<br>Linvatec BioScrew® Absorbable Interference Screw (K973758) |

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 cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).

Indications for Use: The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.

Safety and Performance: Functional and integrity bench testing and Biocompatibility testing (according Sately and I criormance. I antenoid and ante and Memoradum #G95-1, 1995, Use of International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" were performed, 100-10035, "brooked the substantial equivalence of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit. Specifically, testing was performed to determine the initial fixation strength of the proposed RigidFix™ Diporneany, tosting was for Bone-Tendon-Bone grafted ACL Reconstructions.

Conclusion: Based on the Indications for Use, design, technological characteristics and safety and performance testing, the proposed RigidFix™ 2.7mm BTB Cross Pin Kit 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 shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a bird or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Ms. Jennifer Johnson Regulatory Affairs Associate Mitek Products Ethicon, Inc., a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K013781

Trade Name: Rigidfix ™ 2.7mm BTB Cross Pin Kit Regulation Number: 888.3030 Regulation Number. 866:5050
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTY, MAI Dated: November 13, 2001 Received: November 14, 2001

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section > roke its 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 Your may enactment uate of the Medical Dories Finesal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, basyev to equirements for annual registration, listing of devices, Controls provisions of the receively, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see acc re) and additional controls. Existing major regulations (Fremarks) Approval), it they of Sale of Federal Regulations, Title 21, Parts 800 to 895. arrecting your do rios bant determination assumes compliance with the current Good A substantially cquiralent determination as set forth in the Quality System Regulation (QS) for Manufacturing Fractice requirements, as 3 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 10 Inspections, the rood and Drug Nammonation of Collection. In addition, FDA may publish comply with the GMT regaration may readine in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premation stations 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) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Driving of cassion for your device and thus, permits your device to proceed to the market.

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Page 2 – Ms. Jennifer Johnson

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific days. I four astic devices), please contact the Office of Compliance at additionally 607.10 for in This dagliestions on the promotion and advertising of your device, [phone]. Additionally, for quest at [phone]. Also, please note the regulation prease connect the Orifice or Compilance an (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from 112012 1 miorination on your responsibilities and in and in at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

lo Mark N Wilkerson

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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RigidFix 2.7mm BTB Tibial Cross Pin Kit

November 13, 2001

## FEB 0 6 2002

Page of 1 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Rigidfix(tm) 2.7mm BTB Cross Pin Kit

Indications for Use: The Mitek RigidFix 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixations for 050. "The Ingraft ACL bone-tendon-bone grafts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109) Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

Mark N. Milliken

OR

'estorative

K013781

510(k) Number