510(k) · Cleared
ClearedPro-Link® & Pro-Link® Ti Barbs 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 Oct 19, 2023 as substantially equivalent to K121151 (Life Spine, Inc., 2012) and 3 other predicates after a 129-day review. Its family tree reaches back 19 generations to 1984.
- Decided
- Oct 19, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 162 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
- 2 generations backK160066 Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2016
- 1 generation backK180642 Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018
- This deviceK231704 Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. · 2023
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 7 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 6 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 5 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 4 generations backK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
- 3 generations backK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
- 2 generations backK160066 Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2016
- 1 generation backK180642 Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018
- This deviceK231704 Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −7 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −6 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −5 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| −4 | K142940 | Endoskeleton TCS System | Titan Spine, LLC | 2015 | 2 |
| −3 | K151596 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, LLC | 2015 | 1 |
| −2 | 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 | — |
| 0 (this device) | K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | 2023 | — |
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 | 23 | 0 |
| 2005 | 14 | 0 |
| 2006 | 8 | 0 |
| 2007 | 9 | 0 |
| 2008 | 21 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K121151 | Pro-Link Cervical Spacer SystemSummary page 4…bral Body Fusion Device Classification: OVE, 21 CFR 888.3080, Class II Primary Predicate: Life Spine Pro-Link Stand-Alone Cervical Spacer System (K121151) Additional Predicate: Life Spine Pro-Link TI Stand-Alone Cervical Spacer System (K180642 & K1… | 2012 |
| * | K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer SystemSummary page 4…dicate: Life Spine Pro-Link Stand-Alone Cervical Spacer System (K121151) Additional Predicate: Life Spine Pro-Link TI Stand-Alone Cervical Spacer System (K180642 & K160066) Genesys Spine AIS-C (K181295) Device Description: The Pro-L… | 2018 |
| * | K160066 | Pro-Link® Stand-Alone Cervical Spacer SystemSummary page 4…tand-Alone Cervical Spacer System (K121151) Additional Predicate: Life Spine Pro-Link TI Stand-Alone Cervical Spacer System (K180642 & K160066) Genesys Spine AIS-C (K181295) Device Description: The Pro-Link® & Pro-Link® Ti Barbs Cervical Spa… | 2016 |
| * | K181295 | Genesys Spine AIS-C Cervical Stand-Alone SystemSummary page 4…edicate: Life Spine Pro-Link TI Stand-Alone Cervical Spacer System (K180642 & K160066) Genesys Spine AIS-C (K181295) Device Description: The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is offered in various device configurations bas… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 22 of the 162 ancestors have a recall of any class.
- 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. 2023, 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® & 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® &…
Read the full statement (135 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231704: Pro-Link® & Pro-Link® Ti Barbs 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/K231704
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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