# K121151: Pro-Link Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Nov 16, 2012 after 214 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: 13 generations back to K841189 (1984). 57 ancestors in all.
116 later devices descend from it; 5 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111835: Plateau Spacer System, Life Spine, Inc. (2011) Summary page 1.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K081194: Interplate Peek Cervical Interbody Fusion Device (Ifd), Rsb Spine, LLC (2008). Our reading of the summary gave K051194, FDA’s number for BD Onecath Peripherally Inserted Central Catheter, Models… (Becton, Dickinson & CO). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “RSB Spine Interplate”.

## Most influential descendants
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own

## Indications for use
The Pro-Link Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation. The Pro-Link 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/K121151
Methodology: https://510kreport.com/methodology