EXACTECH STERILE MODULAR DRILL BIT

{0} 001 K 960720 APR 23 1996 SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION FOR THE PREMARKET NOTIFICATION FOR THE Exactech Sterile Modular Drill Bit K 960720 Exactech®, Inc. Establishment Registration Number 1038671 4613 NW 6th Street Gainesville, FL 32609 Tel: 352/377-1140 Fax: 352/378-2617 Contact Person: Martha C. Miller Director Regulatory Affairs *Exactech Sterile Modular Drill Bit* The Exactech Sterile Modular Drill Bit is made of similar materials and is of a similar design to devices that were on the market before May 28, 1976. Additionally, the Sterile Drill Bit is of a similar design to other devices on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to: - DePuy Drill Bit Similarities/Dissimilarities: The DePuy drill system is similar to the Exactech system in that the cross pin in the bit and the bayonet locking mechanism operate in a like fashion. The flex shafts are both multiple wrapped springs. They differ in the diameters and lengths of the bits that are offered in the system. The DePuy flex shaft is slightly longer and the Exactech flex shaft is slightly stiffer. The DePuy shaft has a Hudson locking end and the Exactech flex shaft has a Trinkle locking end. The 45° fixed angle drivers are similar in all fashions. Exactech, Inc. has supplied advertisements, brochures and/or catalog information from these companies to the FDA as evidence of equivalency. This literature is in the public domain. In addition, Exactech has provided the FDA design drawings, material specifications and photos of the Sterile Modular Drill Bit. {1} 002 1. Classification This device is appropriately placed in FDA classification: Drill: Bit, Drill. Number 87HTW, Class I device, under 21 CFR 888.4540. 2. Common Name: Drill Bit 3. Trade Name: Exactech Sterile Modular Drill Bit 4. Device Description The Exactech Sterile Drill Bit is intended for use in orthopedic procedures for drilling bone. The drill bit is designed with a 120° point angle for smooth, effective, bone cutting. The 30° helix angle maintains strength, but provides an efficient channel by which cut bone may escape. The outer diameter (OD) tolerance and associated drill bit guide geometry minimize drill bit damage. The five (5) modular bits are designed in long and short versions. They have a high tolerance press fit cross pin that provides easy assembly and disassembly with positive bayonet style locking capability in both the flexible and fixed angle drill bit drivers. All bits are constructed of 455 stainless steel for strength, hardness and resistance to wear. 5. Material Specifications The Sterile Drill Bits are constructed of Custom 455® stainless steel. 6. Mechanical Properties Typical mechanical properties can be found in the Carpenter Technology manual: Custom 455® Stainless section. 7. Sterilization The Exactech Sterile Drill Bits will be supplied sterile. They will be sterilized in their final, sealed packages by gamma irradiation at a contract sterilization facility. The sterilization protocol will be based on the Guidelines for Radiation Sterilization of Medical Devices, issued by the Association for Advancement of Medical Instrumentation Process Control. {2} 003 # Indications: The Sterile Modular Drill Bit is indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement # Manufacturing/Packaging/Sterilization Sites: # Manufacturing/Packaging: | Exactech® Inc. 4613 NW 6th Street Gainesville, FL 32609 Phone: 352/377-1140 Fax: 352/378-2617 | FDA Establishment No: 1038671 | | --- | --- | # Contract Sterilization Sites: | Sterigenics International 305 Enterprise Drive Westerville, Ohio 43081-8827 Phone: (614) 888-4077 Fax: (614) 888-4223 | FDA Establishment No: 1526534 | | --- | --- | | Sterigenics International 18011 Withers Cove Park Drive Charlotte, North Carolina 28273 Phone: (704) 588-6877 Fax: (704) 588-8355 | FDA Establishment No: 1058584 | | --- | --- | # Applicant or Sponsor: | Exactech®, Inc. 4613 NW 6th Street Gainesville, FL 32609 | FDA Establishment No: 1038671 | | --- | --- | # Contact Person: Martha C. Miller<br/> Director, Regulatory Affairs<br/> Telephone: 352/377-1140<br/>Fax: 352/378-2617