Integra External Fixation System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 6, 2016 Ascension Orthopedics % Ms. Jayana Kenana Regulatory Associate Integra LifeSciences 311 Enterprise Drive Plainsboro, New Jersey 08536 Re: K160830 Trade/Device Name: Integra® External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 7, 2016 Received: June 8, 2016 Dear Ms. Kenana: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Vincent J. Devlin -S for - Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) Device Name Integra® External Fixation System Indications for Use (Describe) The Integra® External Fixation System is an external fixation device in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include: - · Correction of deformity - · Revision procedures where other treatments or devices have been unsuccessful - · Bone reconstruction procedures - · Fusions and replantations of the foot - · Charcot reconstruction and Lisfranc dislocations - · Ankle distraction (arthrodiastasis) Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 5. 510k Summary | Device Trade Name: | Integra® External Fixation System | |--------------------|-----------------------------------| | Date: | March 23, 2016 | | Sponsor: | Integra® LifeSciences Corporation | Contact Person: Integra Life Sciences Corp Jayana Kenana Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, NJ 08536 609-936-2657 jayana.kenana@integralife.com ### Manufacturer: Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin, TX 78754 609-936-2657 jayana.kenana@integralife.com | Common Name: | External Fixation Device | |--------------------------|-------------------------------------------------------------------------------------------------| | Device Classification: | Class II | | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) | | Regulation: | 21 CFR 888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories | | Device Regulation Panel: | Orthopedic | | Device Product Code: | Orthopedic KTT | {4}------------------------------------------------ ## Device Description: The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. The modifications to the device include material and minor design updates to the Universal Wire Fixation Bolt and Slotted Posts which do not affect the safety and effectiveness of the device. An update was also made to the position of the olive on the 530mm olive wire. Lastly, the sharpness of the olive wire and k-wire were modified. ### Implants: ### Half-pin Bone Screws The self-drilling half-pin bone screw is 200mm in length and offered in the following sizes: 4mm diameter w/ 20mm thread length, 4mm diameter w/ 30mm thread length, 4mm diameter w/ 40mm thread length, 5mm diameter w/ 30mm thread length, 5mm diameter w/ 40mm thread length, 5mm diameter w/ 50mm thread length, 6mm diameter w/ 30mm thread length, 6mm diameter w/ 40mm thread length, and 6mm diameter w/ 50mm thread length. ### K-wires The wires are offered in the following sizes: 400mm smooth, 400mm olive, and 530mm olive. K-wire washer in 1 size # Single Use Components: #### Rings Full Ring- The full ring is offered in the following sizes: 140mm, 160mm, 180mm, and 200mm. Half Ring- The half ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm. 5/8" Ring- The 5/8" ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm. Cross bar - Two lengths ### Foot Plates The foot plate is offered in the following sizes: 140mm, 160mm, and 180mm. ### Struts Struts are offered in the following lengths: long (180-230mm), medium (140-180mm), and short (95-140mm). # Rocker bottom #### K-wire holding bolts Half pin clamps ### Extensions: Threaded rods (20mm through 200mm, hex posts (20mm through 60mm), cubes (1, 2, 3, and 4 hole) {5}------------------------------------------------ #### Miscellaneous components: Washers, nuts, bolts (10mm through 18mm), universal joint, slotted posts (small and large), and plates ( straight and twisted). #### Reusable Instruments: - Wire tensioner Wrenches Wire cutters Wire Benders AO adapters Holding and alignment Blocks Drill guide assembly Drills Provisional Alignment Guides ### Intended Use: The Integra® External Fixation System is a single-use modular external fixator consisting of rings, half-pin bone screws, wires, and struts and is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation. #### Indications for Use: The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include: - · Correction of deformity - · Revision procedures where other treatments or devices have been unsuccessful - · Bone reconstruction procedures - · Fusions and replantations of the foot - · Charcot reconstruction and Lisfranc dislocations - · Ankle distraction (arthrodiastasis) ### Technological Characteristics: There are no technological characteristics that raise new issues of safety or effectiveness. ### Assessment of performance data: The performance of the Integra® External Fixation System was verified to be statistically equivalent to that of the predicate device (Integra External Fixation System, K140463). The {6}------------------------------------------------ material change done to the wire fixation bolt on the Integra External Fixation System construct were tested both dynamically and statically. The performance testing done on the wire fixation bolt was applied to the material change of the slotted posts to 17-4 SS. The stiffness of the 2 systems was compared and was statistically equivalent. A torsional strength test, static wire retention test, and dynamic wire retention test was performed. Validation was performed on the shift of position of the olive on the olive wire and it was concluded that further verification testing was not needed. Validation was performed on the sharpness of the wires and because this modification has no effect on part strength no further verification testing was performed. # Legally Marketed Predicate Device: Integra® External Fixation System (K140463) ### Predicate Indications for Use: The Integra® External Fixation System (K140463) is indicated for: Use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include: - · Correction of deformity - · Revision procedures where other treatments or devices have been unsuccessful - · Bone reconstruction procedures - · Fusions and replantations of the foot - · Charcot reconstruction and Lisfranc dislocations - · Ankle distraction (arthrodiastasis) ### Purpose: The purpose of this Special 510(k) submission is to gain clearance for the Integra® External Fixation System device modifications including the material change and design updates performed on the Universal Wire Fixation Bolt and Slotted Post. The submission also introduces the minor modifications to the olive location on the olive wire and the sharpness on the olive wire and k-wire. Based upon the similarities of the Integra External Fixation System and the predicate devices studied, the safety and effectiveness of the Integra External Fixation System is substantially equivalent to the predicate device referenced.