CANNULATED SCREW SYSTEM

{0}------------------------------------------------ K003496 10F2 #### 510(K) SUMMARY V # Pioneer Surgical Technology 510(K) Notification Summary: Cannulated Screw System by Pioneer ### ADMINISTRATIVE INFORMATION | Manufacturer Identification<br>And Sponsor | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, Michigan 49855-1781<br>Telephone: (906) 226-9909<br>Facsimile: (906) 226-9932 | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Amy H. Mommaerts, Manager<br>Regulatory Affairs | Date Prepared ................................................................................................................................................................ ### DEVICE IDENTIFICATION | Proprietary Name | Cannulated Screw System by Pioneer | |-----------------------|------------------------------------| | Common Name: | Cannulated Screw | | Classification Name | Screw, Fixation, Bone | | And Reference | Screw, Fixation, Bone | | Regulation Number | 888.3040 | | Classification Number | 87HWC | | | | | Proprietary Name | Cannulated Screw System by Pioneer | | Common Name: Screw | Washer | | Classification Name | | | And Reference: Screw | Washer, Bolt, Nut, Orthopaedic | | Regulation Number | 888.3030 | | Classification Number | 87HTN | ## Devices on Which Substantial Equivalence is Claimed The Cannulated Screw System by Pioneer is predicated on the ZIMMER MAGNA-Fx; the ZIMMER Mini MAGNA-Fx; and the Synthes Cannulated Screw System. ### Device Description The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, lengths and thread configurations to accommodate variations in surgical technique and severity level of fracture. The system includes correspondingly sized washers, the use of which is optional. The cannulated screws are self-cutting and self- {1}------------------------------------------------ K003496 2 OF 2 tapping in appropriate bone stock, which maximizes OR efficiency. The threads are tapping in approphato bone otew removal and decreasing the chance of breakage. reverse batting, faoilitating of engle use and will be offered both sterile and nonsterile. #### Intended Use The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following: - Fractures of the tarsals and metatarsals; 1. - Metatarsal and phalangeal osteotomies; 2. - Fractures of the carpals and metacarpals; 3. - Carpal and metacarpal arthrodesis; ধ: - Small fragments of the hand and wrist; 5. - Ligament fixation; 6. - Sacroillac ioint disruptions; 7. - Fractures of the distal femur and proximal tibia; 8. - Intracapsular fractures of the hip; 9. - 10. Ankle arthrodesis; - 11. Pelvis and acetabulum fractures; and - 12. Areas where accurate screw placement is vital. This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device. ## Technological Characteristic Compared to Predicate Device The Cannulated Screw system by Pioneer was designed referencing the following ASTM standards, similar to the predicate Zimmer Magna-FX, Mini Magna-FX and AO Hi Standardo, Similar to the production for Metallic Medical Bone Screws; and 2) F 116, Standard Specification for Medical Screwdriver Bits #### Performance r oreemianes Based on the screw material equivalence in the proposed system an at least equivalent comparison has been logically derived from the information available. #### Performance Data The Cannulated Screw System by Pioneer is predicated on the use Zimmer Magna-FX and Synthes Cannulated screws. The Cannulated Screw system by Pioneer will be evaluated and compared to the predicate devices with the following ASTM Test standards: 1) F 1691, Standard Test Method for Determining the Axial Pull-Out Strength of Medical Bone Screws; 2) F 117, Standard Test Method for Driving Torque of Medical Bone Screws; and 3) F 1622, Standard Test Method for Measuring the Torsional Properties in Metallic Bone Screws. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right. Public Health Service FEB = 8 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Amy H. Mommaerts Manager, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855 Re: K003496 Trade Name: Cannulated Screw System Regulatory Class: II Product Codes: HTN and HWC Dated: November 10, 2000 Received: November 13 2000 ### Dear Ms. Mommaerts: We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Sccubit 910(x) notifically equivalent (for the indications for use above and we have determined the correct in interstate commerce prior to May 28, 1976, the stated in the elieboute) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Dovieo Frinentialized, brug, and Cosmetic Act (Act). The program accordance with the provisions of the reacted control provisions of the Act. The general therefore, market the device, subject to answal registration, listing of devices, control provisions of the fiel merilibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III 11 your device is classified (see acc re) and additional controls. Existing major regulations (Pleniance Apployal), it may of success to sates from the Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your devroe can or remination assumes compliance with the current Good A substantially cquiralent covernent, 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 mspections, the Food and Drug Hammesult in regulatory action. In addition, FDA may publish Comply with the GMI Tegatator may readeral Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promation houseaus 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) premarket I his letter will anow you to ocgin maxantial equivalence of your device to a legally marketed nontication. The I Driving sification for your device and thus, permits your device to proceed to the market. {3}------------------------------------------------ # Page 2 - Ms. Amy H. Mommaerts If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in Vitro diagnostic no nother promotion and advertising of your device, (301) 594-4659. Additionally, for questions of the pressent the regulation please contact the Office of Compliance at (301) ->++0.5: "(21 CFR 807.97). Other general entitled, "Misbranding by reference to premarks obteined from the Division of Small entitled, "Misbranding by reference up perilance. Inonited from the Division of Small information on your responsibilities under the Act may be obtained from the Division of information on your responsibilites under (800) 638-2041 or at (301) 443-6597, or at its Manufacturers Assistance at its toll-free 111 Mandracturers 715siblantes av fda.gov/cdrh/dsmamain.html". Sincerely yours, L. Mark N. Milkman 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 {4}------------------------------------------------ Page of 510(k) NUMBER (IF KNOWN): K003496 DEVICE NAME: Cannulated Screw INDICATIONS FOR USE: The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following: - 1. Fractures of the tarsals and metatarsals; - 2. Metatarsal and phalangeal osteotomies; - 3. Fractures of the carpals and metacarpals; - 4. Carpal and metacarpal arthrodesis; - 5. Small fragments of the hand and wrist; - 6. Ligament fixation as appropriate; - 7. Sacroiliac joint disruptions; - 8. Fractures of the distal femur and proximal tibia; - 9. Intracapsular fractures of the hip; - 10. Ankle arthrodesis; and - 11. Pelvis and acetabulum fractures; This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device. AhMounacb- 01/22/01 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) for Mark N Melkers (Division Sign-Off) Division of General, Restorative and Neurological Devices K003496 510(k) Number.