# K141005: Z-Link Cervical

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Aug 7, 2014 after 111 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: 14 generations back to K841189 (1984). 107 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.
- K120576: Zavation Ibf System, Zavation, LLC (2012) Summary page 5.
- K121852: Synthes Zero-P Variable Angle (VA), Synthes Spine Co.Lp (2012) Summary page 5.
- K122630: IN:C2 Spinal Fixation System, Spine Smith Partners L.P. (2012) Summary page 5.
- K131449: Coalition Spacer, Globus Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K152972: Amendia Stand-Alone Cervical System (2016), 3 descendants of its own
- K210044: Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System (2021), 1 descendant of its own
- K230607: SPICCA Cervical Fusion Cages (2023), 0 descendants of its own
- K210382: Blustone Synergy Diamond SA Cervical System (2021), 0 descendants of its own

## Indications for use
The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.

Source page: https://510kreport.com/device/K141005
Methodology: https://510kreport.com/methodology