510(k) · Cleared
ClearedInvictus™ OCT Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · NKG Posterior Cervical Screw System
Cleared on Dec 18, 2020 as substantially equivalent to K191185 (Alphatec Spine, 2019) and 8 other predicates after a 60-day review. Its family tree reaches back 28 generations to 1984. 3 of the 903 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 18, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 28 generations to K841189 (1984). 902 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 3 of the 903 devices in this family, counting this one, have a Class I recall.
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations between
- 3 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 1 generation backK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- This deviceK203125 Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 28 generations
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 26 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 25 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 22 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 21 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 18 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 17 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 16 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 15 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 14 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 13 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 12 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 11 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 10 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 8 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 7 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 6 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 3 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 1 generation backK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- This deviceK203125 Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −27 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −26 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −25 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −22 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −21 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −18 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −17 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −16 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −15 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −14 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −13 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −12 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −11 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −10 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −8 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −6 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −3 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −2 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −1 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| 0 (this device) | K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 16 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 24 | 0 |
| 1999 | 20 | 0 |
| 2000 | 30 | 0 |
| 2001 | 41 | 0 |
| 2002 | 39 | 0 |
| 2003 | 45 | 0 |
| 2004 | 72 | 0 |
| 2005 | 57 | 0 |
| 2006 | 43 | 0 |
| 2007 | 47 | 0 |
| 2008 | 83 | 1 |
| 2009 | 53 | 0 |
| 2010 | 40 | 2 |
| 2011 | 42 | 0 |
| 2012 | 27 | 0 |
| 2013 | 32 | 0 |
| 2014 | 31 | 0 |
| 2015 | 33 | 0 |
| 2016 | 16 | 0 |
| 2017 | 13 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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.
3 devices in this family have 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K191185 | Solanas® Posterior OCT Fixation SystemSummary page 4…e Trade Name Manufacturer Primary Predicate Device Solanas® Posterior OCT Fixation K191185 NKG, KWP Alphatec Spine Sys… | 2019 |
| * | K200936 | Invictus™ CT Spinal Fixation SystemSummary page 4…System Additional Predicate Devices Invictus™ CT Spinal Fixation K200936 NKG Alphatec Spine Sys… | 2020 |
| * | K153631 | Zimmer Virage OCT Spinal Fixation SystemSummary page 4…Alphatec Spine System Zimmer Virage® OCT Spinal K153631 NKG, KWP Zimmer Spine Fixation… | 2016 |
| * | K161032 | neon3™ universal OCT spinal stabilizationSummary page 4…Zimmer Spine Fixation System Neon3™ Universal OCT Spinal K161032 NKG, KWP Alphatec Spine Stabi… | 2016 |
| * | K111076 | Solanas Avalon Posterior Fixation SystemSummary page 4…Alphatec Spine Stabilization Solanas Avalon Posterior K111076 NKG, KWP, MNI Alphatec Spine Fixatio… | 2011 |
| * | K093319 | Nuvasive Vuepoint Oct SystemSummary page 4…Alphatec Spine Fixation System NuVasive® VuePoint® OCT K093319 KWP Nuvasive System… | 2010 |
| * | K200130 | M.U.S.T. MINI Posterior Cervical Screws SystemSummary page 4…Nuvasive System M.U.S.T. MINI Posterior Medacta K200130 NKG, KWP Cervical Screws System International SA… | 2020 |
| * | K161363 | Arsenal Spinal Fixation SystemSummary page 5…tus™ OCT Spinal Fixation System 510(k) Product Code Trade Name Manufacturer NKB, KWP, MNH, K161363 MNI, OSH Arsenal® Spinal Fixation System Alphatec Spine Inv… | 2016 |
| * | K192938 | Invictus™ Spinal Fixation SystemSummary page 5…K161363 MNI, OSH Arsenal® Spinal Fixation System Alphatec Spine Invictus™ Spinal Fixation K192938 NKB.KWP Alphatec Spine… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 8 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 8 months on median.
- 106 of the 902 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K191185.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The lnvictusTM OCT Spinal Fixation System is intended to provide inunobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7), and the thoracic spine from Tl-TI: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical…
Read the full statement (184 words)
The lnvictusTM OCT Spinal Fixation System is intended to provide inunobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7), and the thoracic spine from Tl-TI: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confmned by radiographic studies, and degenerative disease of the facets with instability. The Invictus OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the InvictusTM Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203125: Invictus™ OCT Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203125
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