CAPRI Corpectomy Cage System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. February 24, 2022 K2M, Inc. Renee Norby Senior Regulatory Affairs Specialist 600 Hope Parkway SE Leesburg, Virginia 20175 Re: K211320 Trade/Device Name: CAPRI Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: February 14, 2022 Received: February 16, 2022 Dear Renee Norby: 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). 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Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211320 #### Device Name CAPRI Corpectomy Cage System #### Indications for Use (Describe) CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine. When used in the cervical spine (C2-T1), CAPR Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor. fracture, or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems. When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| 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. 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The color of the text is black, and the background is white. | 510(k) Summary: CAPRI Corpectomy Cage System | | | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Submitter: | K2M, Inc. | | | | 600 Hope Pkwy SE | | | | Leesburg, VA 20175 | | | Contact Person : | Name: Renee Norby | | | | Phone: 201-725-4954 | | | | Email: renee.norby@stryker.com | | | Date Prepared: | April 29, 2021 | | | Trade Name: | CAPRI Corpectomy Cage System | | | Common Name: | Vertebral Body Replacement Device | | | Proposed Class: | Class II | | | Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) | | | Product Code: | PLR, MQP | | | Predicate Devices: | Primary Predicate: | | | | • Stryker CAPRI Corpectomy Cage System (K180665) | | | | | | | | Additional Predicate: | | | | • Zavation Medical Products LLC - Normandy VBR System (K191423) | | | | Reference Predicates: | | | | • DePuy - Surgical Titanium Mesh (K003043) | | | | • Stryker Spine - CAPRI Thoracolumbar (K142016) | | | | • Stryker Spine - Santorini Expandable (K111294) | | | Device Description: | The CAPRI Corpectomy System implants are vertebral body replacement | | | | devices that are designed in a variety of lengths, widths, and heights to match | | | | the patient's anatomy. Static (titanium) and expandable (titanium and cobalt | | | | chrome) cervical cages are available and are implanted via an anterior | | | | approach. The cervical implants of the CAPRI Corpectomy Cage Systems are | | | | manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt | | | | Chrome (per ASTM F1537). The purpose of this Traditional 510(k) | | | | submission is to introduce a new 12x14mm cervical expandable footprint size | | | | to the previously cleared CAPRI Corpectomy Cage System. | | | | Function: The system is used to provide structural stability in skeletally | | | | mature individuals following a corpectomy or vertebrectomy. | | | 510(k) Summary: CAPRI Corpectomy Cage System | | | | Intended Use: | CAPRI Corpectomy Cages are vertebral body replacement devices intended<br>for use in the cervical and thoracolumbar spine. | | | | When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages<br>are intended for use in skeletally mature patients to replace a diseased or<br>damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for<br>reconstruction following corpectomy performed to achieve decompression of<br>the spinal cord and neural tissues in cervical degenerative disorders. These<br>cages are intended to restore integrity of the spinal column even in the<br>absence of fusion for a limited time period in patients with advanced stage<br>tumors involving the cervical spine in whom life expectancy is of insufficient<br>duration to permit achievement of fusion, with bone graft used at the<br>surgeon's discretion. | | | | When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable<br>cages are intended for use to replace a collapsed, damaged, or unstable<br>vertebral body due to tumor and trauma (i.e. fracture). These are designed to<br>provide anterior spinal column support even in the absence of fusion for a<br>prolonged period. | | | | The interior of the cages can be packed with autograft or allogenic bone graft<br>comprising cancellous and/or corticocancellous bone graft as an adjunct to<br>fusion. | | | | When used in the thoracolumbar spine, the CAPRI Static and Expandable<br>Corpectomy cages are intended to be used with supplemental internal<br>fixation appropriate for the implanted level, including K2M Pedicle Screw and<br>Hook Systems, and K2M Spinal Plate Systems. | | | | When used in the cervical spine at one or two levels, the CAPRI Static and<br>Expandable cages are intended to be used with supplemental fixation cleared<br>by the FDA for use in the cervical spine. When used at more than two levels,<br>supplemental fixation should include posterior fixation which is cleared by<br>the FDA. | | | Summary of the<br>Technological<br>Characteristics | The subject device (a new expandable footprint in the CAPRI Corpectomy<br>Cage System) shares the same materials, fundamental scientific<br>technologies, and design characteristics as the predicate device in the CAPRI<br>Corpectomy Cage System. The purpose of this submission is to introduce a<br>new cervical expandable footprint size to the CAPRI Corpectomy Cage<br>System, which retains the previously FDA cleared indications/intended use | | | 510(k) Summary: CAPRI Corpectomy Cage System | | | | | and mode of operation as presented in the previous 510(K) submission, K180665. | | | Summary of the<br>Performance Data | The following mechanical tests were performed:<br>Static Compression per ASTM F2077-18 Dynamic Compression per ASTM F2077-18 Static Torsion per ASTM F2077-18 Dynamic Torsion per ASTM F2077-18 Subsidence per ASTM F2267-04 R18 Static Expulsion | | | Conclusion | Based on the design features, the use of established well known materials, feature comparisons, indications for use, and results of the mechanical testing, the new cervical expandable footprint of the CAPRI Corpectomy System has demonstrated substantial equivalence to the identified predicate. | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black and the background is white. The font is modern and the letters are closely spaced. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black, and the background is white. There is a thin black line below the word.