# K200458: Tailored-C Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Bespoke Technologies
- Decided: Dec 28, 2020 after 307 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 319 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 323 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 5.
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX, Centinel Spine, Inc. (2018) Summary page 5.
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 5.
- K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, Ht Medical, LLC (2017) Summary page 5.

## Most influential descendants
- K230607: SPICCA Cervical Fusion Cages (2023), 0 descendants of its own
- K222903: Tailored-H Cervical Stand Alone System (2022), 0 descendants of its own
- K212450: Keos Anterior Cervical Interbody Fusion Device System (2022), 0 descendants of its own

## Indications for use
The Tailored-C Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Tailored-C Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K200458
Methodology: https://510kreport.com/methodology