REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG

{0}------------------------------------------------ APR 1 8 2005 ### 510(K) SUMMARY page 1 of 2 Subject 510(k) Number - K0433339 Sponsor ## Xtremi-T, LLC 3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, New Jersey 08648 ### FDA Establishment Registration Number 3004613836 #### Official Contact Shawn T. Huxel, President Xtremi-T, LLC 3131 Princeton Pike; Bldg 5, Suite 200 Lawrenceville, New Jersey 08648 Phone - (609) 896-0008 Fax - (908) 842-0310 Mobile - (908) 896-5893 #### Proprietary Name ReFIX™ Internal Fixation Pins #### Common Name Biodegradable Internal Fixation Device ### Classification Name and Reference 888.3040 -- Smooth or Threaded Bone Fixation Fastener Regulatory Class Class II Device Product Code (Panel 87) HTY Date Prepared 14 March, 2005 Xtremi-T, LLC Confidential Pg 14 of 112 {1}------------------------------------------------ K043339 Page 2 of 2 ### Brief Description of Device Brief Desoription of Internal Fracture Fixation Devices based upon ReFIX":" Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The orthopaedic specialty. The ReFTX Pins are manufactured from exch supplied i orthopaedic specialty. The ReFTX Phis are niamatacanon and 4.5mm, each supplied in a pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, the ReFIX pins are available in diameters of 2.0mm, 2.7mm, Stance, atively using the ReFIX length of 70mm. The pins are sized and trimmed intraction and materials are de length of 70mm. The pins are sized and unimited misues and materials are designed to address the indications cited. #### Indications for Use midications for USC ReFIX Biodegradable Pins are intended to use in and arthrodeses; and fixation fragments of fractured non-load bearing bones, osted broads and fixation fragments of fractured non-load ocaring bones, osteochondral fragments and cancellous/non-load bearing fragments. For example, ReFIX pins are intended for use in the following procedures: - fixation of phalangeal fusion and fracture . - repair of metacarpal fusion and fracture t - fixation of hand and wrist fractures . - fixation of metatarsal osteotomies . - correction of hallux valgus ● #### Basis for Substantial Equivalence Dasis for Oubstantial equivalence of the ReFIX Pins is based on the equivalence in intended I no substantial verational principals, and indications to: | DEVICE | Manufacturer | Trade Name | |---------|--------------|----------------------| | K010983 | Bionx | PLLA Pin | | K003659 | Bionx | PLGA Pin | | K925098 | Bionx | Biofix Pin | | K031712 | Inion | OTPS Pin | | K040500 | Biomet | Lactonail | | K011522 | Biomet | Resorbable Bone Pins | | K990291 | Biomet | Lactosorb Bone Pin | | K953194 | Biomet | Lactosorb Bone Pin | | K890902 | D&G | Biofix Pin | | K901456 | J&J | Orthosorb | | K864912 | J&J | PDS Pin | #### END OF 510(K) SUMMARY Xtremi-T, LLC Pg 15 of 112 Confidential {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle. APR 1 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Shawn T. Huxel President, GM Xtremi-T, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648 Re: K043339 K043339 Trade/Device Name: ReFix Internal Fracture Fixation Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: March 14, 2005 Received: March 15, 2005 Dear Mr. Huxel: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) premainted instally equivalent (for the indications referenced above and have determined the device is substantial in interests a for use stated in the enclosure) the art acted predicate devices marketed in interstate for use stated in the enclosure) to regally mancetod proce Amendments, or to commerce prior to May 28, 1970, the chacanene with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance what approval application (PMA). and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosment Act (Act) that do not require to the general controls provisions of the Act. The Act. The Act. The You may, merelote, market the device, saloject or use ments for annual registration, listing of general controls provisions of the Act include requirements michaeading and general controls provisions of the received required in the bronibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into or regulations affecting your device it may be subject to such additional controls. Existing major regulation FDA it may be subject to such additional controls: "Intering and to 898. In addition, FDA can be found in the Code of Federal Regulations, Title 21, Parts 800 to Analysis can be lound in the Code of I edela. Regulation in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a subscribed with other requirements of the Act that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon that your acered by other Federal agencies. You must or any Federal statules and regulations administered of the registration and listing (21). comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, mendants, wartice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Fart on ); good manafanting production in electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the el forth in the quality systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 {3}------------------------------------------------ Page 2- Mr. Shawn T. Huxel This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin makemig your article walness of your device to a legally premarket notification. The FDA finding of substantial end the permits vour premarket notification. The I DA Inding of oublication 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), please s and the may of the may on 1100 m Marceless and the regulation entitled If you desire specific advice for your de vice on our ac access note the regulation entitled, contact the Office of Compliance at (240) 276-0120 . Also, please note the now o contact the Office of Comphalled at (240) 276 - 8 - 4 - 4 - 7 Part 807.97). You may obtain "Misbranding by reference to premarket notification" (21 - 1 - 4 first from the Di "Misbranding by reference to premarket nonlication (1) of Act from the Division of Small . other general information on your responsibilities under (800) 638-204) other general information on your responsion.comer Assistance at its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Assistantes artis courted to the result of the support/index.html. Sincerely yours, Stupt durelu 4 Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Statement of Indications for Use 510 (K) NUMBER IF KNOWN: K043339 MANUFACTURER: Xtremi-T, LLC DEVICE NAME: ReFIX Internal Fracture Fixation Pins Indications: ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of ten the first and the collection beauts and arthrodeses; and ReFTX Biodegradable Plils are intention for assestomies and arthrodoses; and fragments of fractured mou-foad ocuring ochos, est. Secochondral fragments and fixation and/or alignment of apical fragments, osteochondral fragments and fixation and/or alig cancellous/non-load bearing fragments. earses and - fixation of phalangeal fusion and fracture . - repair of metacarpal fusion and fracture � - fixation of hand and wrist fractures . - fixation of metatarsal osteotomies . - correction of hallux valgus . ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use *yes* or Over-the-Counter Use *No* (Per 21 CFR 801.109) (Optional Format 1-2-1996) (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K043339 Xtremi-T, LLC Page 13 of 112 Confidential