510(k) · Cleared
ClearedPro-Link® Stand-Alone 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 Sep 2, 2016 as substantially equivalent to K121151 (Life Spine, Inc., 2012) and 1 other predicate after a 233-day review. Its family tree reaches back 17 generations to 1984. 3 later devices descend from it.
- Decided
- Sep 2, 2016
- Review
- 233 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K841189 (1984). 143 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 2 generations backK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
- 1 generation backK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
- This deviceK160066 Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK180642 Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK231704 Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK191565 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc. · 2019 · Recalled
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 5 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 4 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 3 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 2 generations backK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
- 1 generation backK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
- This deviceK160066 Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018 · cites it directly2descendants
- K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. · 2023 · cites it directly0descendants
- K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −5 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −4 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −3 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| −2 | K142940 | Endoskeleton TCS System | Titan Spine, LLC | 2015 | 2 |
| −1 | K151596 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, LLC | 2015 | 1 |
| 0 (this device) | K160066 | Pro-Link® Stand-Alone Cervical Spacer System | Life Spine, Inc. | 2016 | — |
| +1 | K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | Life Spine, Inc. | 2018 | — |
| +1 | K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | 2023 | — |
| +2 | K191565 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 22 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 8 | 0 |
| 2008 | 20 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K121151 | Pro-Link Cervical Spacer SystemSummary page 4…Intervertebral Body Fusion Device Classification: OVE, 21 CFR 888.3080, Class II Primary Predicate : Pro-Link Cervical Spacer System (K121151) Additional Predicate: Endoskeleton® TCS Interbody Fusion Device (K151596) Device Description: The Pro-Link® Stand-A… | 2012 |
| * | K151596 | Endoskeleton TCS Interbody Fusion DeviceSummary page 4…1 CFR 888.3080, Class II Primary Predicate : Pro-Link Cervical Spacer System (K121151) Additional Predicate: Endoskeleton® TCS Interbody Fusion Device (K151596) Device Description: The Pro-Link® Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion… | 2015 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 16 of the 143 ancestors have a recall of any class.
- Of its descendants, K180642 (Life Spine, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K121151.
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. 2016, 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® 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160066: Pro-Link® Stand-Alone 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/K160066
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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