# K180642: Pro-Link® Ti Stand-Alone Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: May 10, 2018 after 59 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: 18 generations back to K841189 (1984). 145 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121151: Pro-Link Cervical Spacer System, Life Spine, Inc. (2012) Summary page 4.
- K160066: Pro-Link® Stand-Alone Cervical Spacer System, Life Spine, Inc. (2016) Summary page 4.
- K161127: The Small PLATEAU (PLATEAU-C) Spacer System, Life Spine, Inc. (2016) Summary page 4.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 4.

## Most influential descendants
- K231704: Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (2023), 0 descendants of its own
- K191565: Endoskeleton TCS Interbody Fusion Device (2019), 0 descendants of its own

## Indications for use
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation. The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.

Source page: https://510kreport.com/device/K180642
Methodology: https://510kreport.com/methodology