KOMPREDA

{0}------------------------------------------------ ### K120597 MAY 3 2013 # Section VII. 510(K) SUMMARY Date Prepared May 1, 2013 ### Name of Firm Custom Spine, Incorporated 9 Campus Dr. Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707 ### Official Correspondent David Brumfield Senior VP of Research and Development, Quality, and Regulatory 9 Campus Dr. Parsippany, NJ 07054 Phone: (973) 265-5043 Fax: (973) 808-0707 E-mail: dbrumfield@customspine.com Establishment Number 3005129649 #### Device Name Legally Marketed Trade Name: KOMPRESA Facet Screw System Common Name: Facet Screw System Device Classification: Unclassified Reason unclassified: Pre-amendment Device Product Codes: MR W #### Predicate Devices Trans 1 facet screw (K073515), Depuy Spine's DISCOVERY facet screw system (K012773) #### Device Description The subject Kompresa Facet Screw System consist of non-sterile, single use cannulated screws of various diameters and lengths to be used in conjunction with different diameter nuts and a universal collet. The screws, nuts and collets are all made from titanium alloy {1}------------------------------------------------ Ti6Al4V. The Instruments and guide wires are made from various grades of stainless steel or aluminum. ### Indications for Use The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 spinal levels: · - . Trauma, including spinal fractures and/or dislocation - . Spondylolisthesis - Spondylolysis ● - . Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity - . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). - . Degeneration of the facets with instability #### Materials The screws, nuts and collets are made from titanium alloy Ti6AI4V. The instruments are made from various grades of stainless steel or aluminum. #### Performance Data Bench testing was performed to support the equivalence of the proposed facet screw system. Axial pullout, and torque to failure tests were performed per ASTM F543-07. Static and dynamic collet/locknut pull off-tests were performed per ASTM 1798. Static three-point bend and dynamic cantilever bend tests were performed per ASTM F1264-03. Static cantilever bend tests were performed per ASTM 2193-02. #### Substantial Equivalence Statement Documentation is provided to demonstrate that the Kompresa Facet Screw System is substantially equivalent to its predicate devices in terms of its material. design. indications for use, and performance characteristics. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 3, 2013 Custom Spine, Incorporated % Mr. David L. Brumfield 9 Campus Drive Parsippany, New Jersey 07054 Re: K120597 Trade/Device Name: KOMPRESA Facet Screw System Regulatory Class: Unclassified Product Code: MR W Dated: April 19, 2013 Received: April 24, 2013 Dear Mr. Brumfield: 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. {3}------------------------------------------------ ### Page 2 - Mr. David L. Brumfield If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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 Small Manufacturers, International and Consumer Assistance 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. # Erin Meith Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Eyaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Section VI. INDICATIONS FOR USE STATEMENT ## 510(k) Number : _ K120597 The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 (included) spinal levels: - Trauma, including spinal fractures and/or dislocation . - Spondylolisthesis . - Spondylolysis . - Pseudoarthrosis or failed previous fusions which are symptomatic or which may � cause secondary instability or deformity - Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies). - Degeneration of the facets with instability . Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Ronald P. Jean -S (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K120597 Page 1 of 1