Pinehurst Anterior Cervical Plate System

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January 17, 2019 Signature Orthopaedics Pty Ltd. % Dr. Declan Brazil Managing Director 7 Sirius Road Lane Cove, New South Wales 2066 AUSTRALIA Re: K181190 Trade/Device Name: Pinehurst Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: December 19, 2018 Received: December 26, 2018 Dear Dr. Brazil: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Ronald P. Jean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181190 #### Device Name Pinehurst Anterior Cervical Plate System #### Indications for Use (Describe) The Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with: · Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); - · Spondylolisthesis; - · Trauma (I.e fracture or dislocations); - Tumors: - · Deformity (defined as kyphosis, lordosis, or scoliosis); - · Pseudoarthrosis: - · Failed previous fusion; - · Spinal stenosis | Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> | |-------------------------------------------------|---------------------------------------|---------------------------------------| |-------------------------------------------------|---------------------------------------|---------------------------------------| X | 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}------------------------------------------------ #### 2 510(K) SUMMARY | Manufacturer: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade<br>Name: | Pinehurst Anterior Cervical Plate System | | Common Name: | Spinal Intervertebral Body Fixation Orthosis | | Contact: | Dr. Declan Brazil<br>Managing Director of Signature Orthopaedics | | Prepared By: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia<br>Phone: +61 (2) 9428 5181<br>Fax: +61 (2) 8456 6065 | | Date Prepared: | April 30th, 2018 | | Classification: | Class II per 21 CFR 888.3060: Spinal Intervertebral Body Fixation<br>Orthosis (KWQ) | | Predicate Devices: | Primary Predicate<br>L&K Biomed LnK Anterior Cervical Plate System<br>(K143279)<br>Additional Predicate<br>● Spinal Concepts SC-AccFix Thinline Anterior Cervical<br>Plate System (K013979)<br>● Orthofix CETRA Anterior Cervical Plate System<br>(K162638)<br>● Globus Medical PROVIDENCE Anterior Cervical Plate<br>System (K070775)<br>● DePuy Synthes CSLP System (K945700, K000536,<br>K000742, K030866)<br>● Signature Orthopaedics NOOSA Anterior Lumbar Plate<br>System (K163625) | #### Device Description: The Signature Orthopaedics' Pinehurst Anterior Cervical Plate System's components are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136. The Pinehurst Anterior Cervical Plate Systemis temporary supplemental fixation device consisting of variety of shapes and sizes of plates and screws. The plates attach to the anterior cervical spine with a minimum four screw per plate. The plates are offered in {4}------------------------------------------------ one-level, two-level, three-level and four-level fusion configurations. The plates have an integrated locking mechanism that prevents screw-backout. The Pinehurst plates and screws are supplied sterile. ### Indications for Use: The Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with: - Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies); - . Spondylolisthesis; - Trauma (I.e fracture or dislocations); ● - . Tumors: - . Deformity (defined as kyphosis, lordosis, or scoliosis); - Pseudoarthrosis; - Failed previous fusion; - Spinal stenosis #### Performance Testing: Non-clinical testing and engineering evaluations were conducted to verify that the performance of Pinehurst Anterior Cervical Plate System is adequate for anticipated invivo use. The following non-clinical testings were carried out on the worst case sizes of the plates and screws: - . Static and dynamic compression bending testing - . Static torsion testing - Screw insertion testing ● - . Screw pull-out testing - . Screw torque to failure testing #### Substantial Equivalence: That Signature Orthopaedics' Pinehurst Anterior Cervical Plate System have the same intended use, indication for use, materials and similar design features as the Spinal Concepts SC-AccFix Thinline Anterior Cervical Plate System (K013979), L&K Biomed LnK Anterior Cervical Plate System (K143279), Orthofix CETRA Anterior Cervical Plate System (K162638), Globus Medical PROVIDENCE Anterior Cervical Plate System (K070775), Synthes CSLP System (K945700, K000536, K000742, K030866) and Signature Orthopaedic NOOSA Anterior Lumbar Plate System (K163625). Nonclinical testing results support the substantial equivalence claim. #### Comparison of technological characteristics Temporary immobilisation and stabilisation of spinal segments as supplemental fixation in spinal fusion procedure is the technological principle for both the subject device and the predicate devices. The subject and predicate devices are based on the following same technological elements: - . The indication for use of the subject device is the same as the predicate devices {5}------------------------------------------------ - . The intended surgery sites of the subject device is the same as intended surgery sites of the predicates - . The subject device is manufactured from the same material as the predicate devices - . The locking mechanism of the subject device is equivalent to the locking mechanism of LnK and CETRA plate systems - . The profile thickness of the subject device are within the profile thickness of the predicates - The size range of the subject devices fall within the size range of the predicates - . The subject device accommodate the same number of supplemental as the predicate devices - . Both subject device and predicates are contoured to match the vertebral body - . Both subject device and predicates are implanted manually and the screws are hand tightened The following technological differences exist between the subject and predicate devices: - Some of the design features are different between the subject and predicate devices - . The material used on one of the predicates are slightly different than the subject device - The material used for two of the predicate devices are slightly different than the subject device (Ti6Al4V ELI vs Ti6Al4V) - . The screw locking mechanism on two of the predicates are different the subject device ## Conclusions: Technical comparison of the subject and predicate devices demonstrates equivalence in device design, intended use, indications for use and material. Non-clinical data raises no new safety or effectiveness questions of the Pinehurst Anterior Cervical Plate System.