510(k) · Cleared
ClearedPro-Link Cervical Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Nov 16, 2012 as substantially equivalent to K111835 (Life Spine, Inc., 2011) and 3 other predicates after a 214-day review. Its family tree reaches back 13 generations to 1984. 116 later devices descend from it.
- Decided
- Nov 16, 2012
- Review
- 214 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 57 ancestors in all. 116 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 2 generations backK093093 Small Plateau Spacer SystemLife Spine · 2010
- 1 generation backK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
- This deviceK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
- Descendant · cites it directly · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
- Descendant · 2 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- Descendant · 3 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
- Descendant · 4 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 5 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 3 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 2 generations backK093093 Small Plateau Spacer SystemLife Spine · 2010
- 1 generation backK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
- This deviceK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 116 · See all- K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · cites it directly108descendants
- K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 2 generations on93descendants
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 3 generations on72descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 4 generations on67descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 5 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −3 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| −2 | K093093 | Small Plateau Spacer System | Life Spine | 2010 | — |
| −1 | K111835 | Plateau Spacer System | Life Spine, Inc. | 2011 | — |
| 0 (this device) | K121151 | Pro-Link Cervical Spacer System | Life Spine, Inc. | 2012 | — |
| +1 | K132029 | Vault-C Intervertebral Body Fusion Device | Spinal USA | 2013 | — |
| +2 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| +3 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | — |
| +4 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +5 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 13 | 0 |
| 2023 | 19 | 0 |
| 2024 | 19 | 0 |
| 2025 | 25 | 0 |
| 2026 | 21 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111835 | Plateau Spacer SystemSummary page 1…3080, Class 11, Intervertebral Body Fusion Device Predicate Device: The Small Plateau (Plateau-C) Spacer System (K111835) LDR Spine Cervical Interbody Fusion System (KI 113559)… | 2011 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 1…cate Device: The Small Plateau (Plateau-C) Spacer System (K111835) LDR Spine Cervical Interbody Fusion System (KI 113559) Globus Coalition (K0833 89) RSB Spine Interplate (KOSI… | 2011 |
| * | K083389 | Coalition SpacerSummary page 1…pacer System (K111835) LDR Spine Cervical Interbody Fusion System (KI 113559) Globus Coalition (K0833 89) RSB Spine Interplate (KOSI1194) Device Description: The PRO-LINK Cervical Spacer System is… | 2009 |
| * | K081194 | Interplate Peek Cervical Interbody Fusion Device (Ifd) 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”. | 2008 |
What descends from it? (116)
See all 1165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132029 | Vault-C Intervertebral Body Fusion Device | 2013 | 108 |
| K152793 | Unison-C Anterior Cervical Fixation System | 2016 | 29 |
| K160066 | Pro-Link® Stand-Alone Cervical Spacer System | 2016 | 3 |
| K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | 2018 | 2 |
| K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 57 ancestors have a recall of any class.
- Of its descendants, K132029 (Spinal USA, 2013) has gone furthest, with 108 descendants of its own.
- 1 other device also cites its predicate K111835.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121151: Pro-Link Cervical Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121151
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026