# K222903: Tailored-H Cervical Stand Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Bespoke Technologies, LLC
- Decided: Nov 18, 2022 after 56 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 24 generations back to K841189 (1984). 464 ancestors in all.
No later device cites it as a predicate yet.
1 of 465 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System, Nexxt Spine, LLC (2020) Summary page 5.
- K211111: SureMAX-SA Cervical Standalone System, Additive Implants, Inc. (2021) Summary page 5.
- K212853: Cervical Stand-Alone System, Eminent Spine, LLC (2021) Summary page 5.
- K200458: Tailored-C Cervical Interbody Fusion System, Bespoke Technologies (2020) Summary page 5.

## Indications for use
The Tailored-H Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K222903
Methodology: https://510kreport.com/methodology