# K231704: Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Oct 19, 2023 after 129 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: 19 generations back to K841189 (1984). 162 ancestors in all.
No later device cites it as a predicate yet.
0 of 163 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.
- K180642: Pro-Link® Ti Stand-Alone Cervical Spacer System, Life Spine, Inc. (2018) Summary page 4.
- K160066: Pro-Link® Stand-Alone Cervical Spacer System, Life Spine, Inc. (2016) Summary page 4.
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System, Genesys Spine (2018) Summary page 4.

## Indications for use
The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (ODD) with accompanying radicular symptoms at one level from C2- Tl. DOD 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 Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is to be used with autogenous bone graft and implanted via an anterior approach. The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an integrated cervical interbody fusion device intended to be used with two (2) titanium bone barbs. The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screw).

Source page: https://510kreport.com/device/K231704
Methodology: https://510kreport.com/methodology