510(k) · Cleared
ClearedSpineLinc Anterior Cervical Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lincotek Medical · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 5, 2025 as substantially equivalent to K191243 (Globus Medical, Inc., 2019) and 2 other predicates after a 267-day review. Its family tree reaches back 19 generations to 1984.
- Decided
- Dec 5, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 245 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 backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 2 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- This deviceK250764 SpineLinc Anterior Cervical Implant SystemLincotek Medical · 2025
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 backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 6 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 5 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 4 generations backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- 3 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 2 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- This deviceK250764 SpineLinc Anterior Cervical Implant SystemLincotek Medical · 2025
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 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −6 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −5 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| −3 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| −2 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| −1 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| 0 (this device) | K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 24 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 13 | 0 |
| 2008 | 27 | 0 |
| 2009 | 18 | 0 |
| 2010 | 10 | 0 |
| 2011 | 13 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K191243 | HEDRON Cervical SpacersSummary page 5…on, Cervical) Panel: Orthopedic Product Code: OVE, ODP Primary Predicate: Globus Medical HEDRON Spacers – K191243 Device Description: The SpineLinc Anterior Cervical Implant system consists of a cervical interbody fusion device, cervical pl… | 2019 |
| * | K142218 | Coalition AGX Plate and Coalition AGX SpacerSummary page 6…y Predicate: • Globus Medical HEDRON Cervical Spacers – K191243 Additional Predicates: • Globus Medical, COALITION AGX™ Plate and COALITION AGX™ Spacer – K142218 • Elevation Spine SABER-C System – K190885 The subject components are similar in indications to the predicate devices. Dev… | 2015 |
| * | K190885 | Elevation Spine Saber-C SystemSummary page 6…ical Spacers – K191243 Additional Predicates: • Globus Medical, COALITION AGX™ Plate and COALITION AGX™ Spacer – K142218 • Elevation Spine SABER-C System – K190885 The subject components are similar in indications to the predicate devices. Device sizing, geometry, technological characteristi… | 2019 |
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 41 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 245 ancestors have a recall of any class.
- 11 other devices also cite its predicate K191243.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SPINELINC…
Read the full statement (195 words)
The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for
use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1)
for one or two levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by
history and radiographic studies. These patients should be skeletally mature and have had at least
six (6) weeks of non-operative treatment. The SPINELINC Cervical Spacer Body and Anterior
Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of
cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior
Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the
SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When
used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for
use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the
supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone
device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with
three SpinelLinc screws per assembly.
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/K250764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250764: SpineLinc Anterior Cervical Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250764
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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