# K160066: Pro-Link® Stand-Alone Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Sep 2, 2016 after 233 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: 17 generations back to K841189 (1984). 143 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 147 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.
- K151596: Endoskeleton TCS Interbody Fusion Device, Titan Spine, LLC (2015) Summary page 4.

## Most influential descendants
- K180642: Pro-Link® Ti Stand-Alone Cervical Spacer System (2018), 2 descendants of its own
- 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® Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation. The Pro-Link® 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/K160066
Methodology: https://510kreport.com/methodology