510(k) · Cleared
ClearedIdentiTi Cervical Standalone Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 18, 2020 as substantially equivalent to K200543 (Nexxt Spine, LLC, 2020) and 2 other predicates after an 85-day review. Its family tree reaches back 25 generations to 1984. 1 of the 534 devices in its family, counting itself, has a Class I recall. 67 later devices descend from it.
- Decided
- Dec 18, 2020
- Review
- 85 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 25 generations to K841189 (1984). 466 ancestors in all, the oldest K792352 (1979). 67 later devices descend from it, 3 citing it directly. 1 of the 534 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · cites it directly · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · cites it directly · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 2 generations on · 16 of its ownK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 5 of 67 · See all- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · cites it directly59descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · cites it directly36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 2 generations on28descendants
- K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on16descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −1 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| 0 (this device) | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +1 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +1 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +2 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +2 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 17 | 0 |
| 2002 | 15 | 0 |
| 2003 | 20 | 0 |
| 2004 | 31 | 0 |
| 2005 | 25 | 0 |
| 2006 | 17 | 0 |
| 2007 | 20 | 0 |
| 2008 | 53 | 1 |
| 2009 | 33 | 0 |
| 2010 | 21 | 0 |
| 2011 | 29 | 0 |
| 2012 | 20 | 0 |
| 2013 | 22 | 0 |
| 2014 | 24 | 0 |
| 2015 | 16 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 11 | 0 |
| 2024 | 15 | 0 |
| 2025 | 17 | 0 |
| 2026 | 16 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemSummary page 4…ate Nexxt Matrixx Stand Nexxt Spine K200543 OVE Alone Cervical-Turn Lock System Additio… | 2020 |
| * | K170953 | Tomcat Cervical Spinal SystemSummary page 4…l-Turn Lock System Additional Predicate TOMCAT Cervical K170953 OVE Choice Spine Spinal… | 2017 |
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 4…Choice Spine Spinal System ATEC IdentiTi Porous K183705 ODP, OVD, PHM, MAX Alphatec Spine Ti I… | 2019 |
What descends from it? (67)
See all 673 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 53 of the 466 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203742 (Alphatec Spine, Inc., 2021) has gone furthest, with 59 descendants of its own.
- 4 other devices also cite its predicate K200543.
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. 2020, 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 IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative…
Read the full statement (127 words)
The IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or cortico-cancellous bone and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202812: IdentiTi Cervical Standalone Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202812
Report an extraction error
Are you the manufacturer?
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