ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES

{0}------------------------------------------------ K652 062 ## AUG 2 5 2005 ## PART B: 510(k) SUMMARY - Alliance Medical Corporation Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Contact: Moira Barton Requlatory Affairs Manager (480) 763-5300 (o) (480) 763-5310 (f) mbarton@alliance-medical.com July 20, 2005 Date of preparation: Trade/Proprietary Name: Reprocessed External Fixation Name of device: Devices Common or Usual Name: External Fixation Devices, Fixation Appliance, Single/Multiple Component Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories and Smooth or Threaded Metallic Bone Fixation Fastener ## Predicate device(s): - Reprocessed Howmedica® External Fixation Devices K012648 - External fixation devices are specially designed frames, clamps, Device description: rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability. - External Fixation Devices are intended to be used for the Intended use: fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others 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. {1}------------------------------------------------ | Indications<br>statement: | Reprocessed external fixation devices are indicated for use in<br>patients requiring external skeletal fixation and treatment of<br>fractures, osteotomy, arthrodesis, correction of deformities,<br>fracture revision, bone reconstruction procedures, limb<br>lengthening, correction of bony or soft tissue deformities and<br>segmental bony or soft tissue defects. | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>characteristics: | The design, materials, and intended use of the Reprocessed<br>External Fixation Devices are identical to the predicate devices.<br>The mechanism of action of the Reprocessed External Fixation<br>Device is identical to the predicate devices in that the same<br>standard mechanical design, materials, shapes and sizes are<br>utilized. There are no changes to the claims, intended use,<br>clinical applications, patient population, performance<br>specifications, or method of operation. The only change is the<br>modified external fixation devices will be provided non-sterile.<br>Sterilization of the devices will occur in the hospital prior to use. | | Performance data: | Bench and laboratory testing was conducted to demonstrate<br>performance (safety and effectiveness) of the Reprocessed<br>External Fixation Devices.<br>Validation of reprocessing Function Testing<br>Performance testing demonstrates that Reprocessed External<br>Fixation Devices perform as originally intended. | | Conclusion: | Alliance Medical Corporation concludes that the modified device<br>(the Reprocessed External Fixation Device) is safe, effective<br>and substantially equivalent to the predicate devices, as<br>described herein. | : {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES AUG 2 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044 Re: K052062 KU32002 Trade/Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JEC Dated: July 19, 2005 Received: July 25, 2005 Dear Ms.Barton: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate To use stated in the encreate) to tegains and the Medical Device Amendments, or to commerce price to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices that have been recitablicat require approval of a premarket approval application (PMA). and Cosmetic 71ct (11ct) that ao nov request to the general controls provisions of the Act. The I ou may, merelore, mainer are a Act include requirements for annual registration, listing of general oonline provider proctice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clusioned (600 wor of ols. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be actived a determination that your device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must of any I cuteral statutes and equivements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Part 8077, and its systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quany 05001 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Moira Barton This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manxelling of substantial equivalence of your device to a legally prematket notheadon. The PDA inding of backander vol. 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), please s and the may be If you desire specific advice for your ac not the one of the regulation entitled, and comact the Office of Comphalloo at (210) = 6 % = 3 % = 1 807.97). You may obtain " Misbranding by reference to prematics noutheaters" (ex Act from the Division of Small other general information on your responsibility of the toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its to the commiss brokers Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 2. Indications for Use Statement Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices Indications for Use: Reprocessed external fixation devices are indicated for Indications for Use: Replocessed external fixation and treatment of fractures, use in patients requiring external skeletal fixation and treatment on bone use in patients requiring extential sichelring fracture revision, bone osteotomy, arthrodesis, correction of define of hony or soft is osteotomy, arthrodesis, correction of bening, correction of bony or soft tissue reconstruction procedures, limb lengthening, correction of bony or soft tissue reconstruction reconstruction proocuured, iima long or soft tissue defects. Concurrence of CDRH, Office of Device Evaluation (ODE) Signature (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K05206² Prescription Use (per 21 CFR 801.109) \$\checkmark\$ or Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________