SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

{0}------------------------------------------------ K102402 MAR 3 0 2011 510(k) Summary Alphatec Spine, Inc. **Alphatec Spine** Solus Anterior Lumbar Interbody Fusion (ALIF) System ## 510(k) SUMMAR Y March 2011 | Company: | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008 USA<br>Direct: (760) 494-6739<br>Fax: (760) 431-0289 | |---------------------------|------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Karla Schaffner, Regulatory Affairs Submission Specialist | | Trade/Proprietary Name: | Solus Anterior Lumbar Interbody Fusion (ALIF)<br>System | | Common Name: | Intervertebral Body Fusion Device | | Classification Name: | Intervertebral Body Fusion Device | | Classification Number(s): | 21 CFR 888.3080 | | Product Code(s): | MAX | #### Product Description: The Solus Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral body fusion system for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Solus System consists of implants with various sizes and heights available in 7º or 12º lordosis to accommodate individual patient pathology. The implants are manufactured from polyetheretherkeytone (PEEK Optima LT)) material conforming to ASTM F2026 and tantalum radiographic markers (ASTM F560) with internal anchoring blades of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. #### Indications for Use: The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autografi. The device is intended for use with supplemental fixation that is in addition to the integrated blades. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Alphatec Spine. The logo features a stylized lowercase Greek letter alpha above the words "Alphatec Spine" in a bold, italicized font. The logo is black and white. # Substantial Equivalence: The Solus Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the following predicate devices: | System | Clearance | Date | |---------------------------------------------------------|-----------|------------------| | Incite Innovations Fusions Device | K093808 | March 24,2010 | | LDR ROI-A | K080572 | June 25, 2009 | | Synthes Spine SynFix LR Spacer | K072253 | October 12, 2007 | | Novel Anterior Lumbar Interbody Fusion (ALIF)<br>System | K090782 | April 22, 2009 | Data was provided which demonstrated the Solus Anterior Lumbar Interbody Fusion (ALIF) System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, intended use, design, material, and function. ## Performance Data: Testing was performed per ASTM 2077-03 for axial compression, dynamic compression, static compression-shear, static torsion, and dynamic torsion testing of intervertebral fusion devices. Testing was performed per ASTM 2267 for subsidence testing of intervertebral fusion devices. Testing was performed per the draft standard ASTM F-04.25.02.02 for static push-out testing. Cadaveric fatigue testing was performed in Flexion, Lateral Bending and Axial Rotation. Finite element analysis was performed to evaluate the blade /vertebral body interface. The test results demonstrate that the mechanical performance of the Solus Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle. The text is in a simple, sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Alphatec Spine, Inc. % Ms. Karla Schaffner Regulatory Affairs Submissions Specialist 5818 El Camino Real Carlsbad, California 92008 Re: K102402 Trade/Device Name: Solus Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 18, 2011 Received: March 21, 2011 SEP 12 . 01 Dear Ms. Schaffner: This letter corrects our substantially equivalent letter of March 30, 2011. 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 (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. 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 {3}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 vours. Sincerely yours, Mark N. Millikan Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Greek letter alpha in a cursive font. Below the letter, the word "Alphatec" is printed in a bold, sans-serif font. To the right of "Alphatec" are some numbers, specifically 3,549. 510(k) #K102402 Alphatec Spine, Inc. Solus Anterior Lumbar Interbody Fusion (ALIF) System ### INDICATIONS FOR USE 510(k) Number (if known): K102402 Device Name: Solus Anterior Lumbar Interbody Fusion (ALIF) System #### Indications for Use: The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. Prescription Use X (Per 21 CFR 801.109) OR Over-The Counter Use 3 (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices K102402 510(k) Number.