# K202637: F3D Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Dec 23, 2020 after 103 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: 23 generations back to K841189 (1984). 314 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 316 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183588: Choice Spine Hawkeye Vertebral Body Replacement (VBR) System, Choicespine (2019) Summary page 6.
- K191778: Omnia Medical VBR, Omnia Medical, LLC (2019) Summary page 6.
- K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System, K2m, LLC (2018) Summary page 6.

## Most influential descendants
- K230329: F3D Interbody System (2023), 0 descendants of its own

## Indications for use
The F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). When used in the cervical spine (C2-T1), F3D Corpectomy devices 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 spacers are intended to restore the 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), F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Source page: https://510kreport.com/device/K202637
Methodology: https://510kreport.com/methodology