# K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, LLC
- Decided: Nov 28, 2018 after 259 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K841189 (1984). 247 ancestors in all.
9 later devices descend from it; 5 cite it directly.
1 of 257 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162315: FORTIFY Corpectomy Spacers, Globus Medical, Inc. (2017) Summary page 7.
- K170055: CAPRI Corpectomy Cage System, K2m (2017) Summary page 7.
- K171704: CAPRI Corpectomy Cage System, K2m (2017) Summary page 7.
- K172032: Modulift Vertebral Body Replacement (VBR) System, Aesculap Implants Systems, Inc. (2017) Summary page 7.
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System, Nu Vasive, Incorporated (2015) Summary page 7.

## Most influential descendants
- K211320: CAPRI Corpectomy Cage System (2022), 2 descendants of its own
- K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own
- K202637: F3D Corpectomy System (2020), 1 descendant of its own
- K200235: KONG-TL VBR System, KONG-C VBR System (2020), 1 descendant of its own
- K193412: NEXXT MATRIXX System (2020), 1 descendant of its own

## Indications for use
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine. When used in the cervical spine (C2-T1), SANTORINI 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 corpectomy performed to achieve decompression of the spinal cord and neural 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 tumors 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), SANTORINI cages are iniended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages 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 Santorini 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 SANTORINI Corpectomy Cage System is 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 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), CAPRI Static 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 corpectomy performed to achieve decompression of the spinal cord and neural 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 tumors 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 tumer and trauma (i.e. fracture). These cages 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 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

Source page: https://510kreport.com/device/K180665
Methodology: https://510kreport.com/methodology