510(k) Report

510(k) · Cleared

Cleared

Invictus® Small Stature Spinal Fixation System

K241519510(k) TraditionalCleared Jun 21, 202423-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alphatec Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 21, 2024 as substantially equivalent to K232275 (Alphatec Spine, Inc., 2023) and 6 other predicates after a 23-day review. Its family tree reaches back 32 generations to 1984. 2 of the 1,098 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.

Decided
Jun 21, 2024
Review
23 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 32 generations to K841189 (1984). 1,095 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 2 of the 1,098 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2023: 1 other ancestor2018: 17 other ancestors2016: 24 other ancestors2015: 37 other ancestors2012: 36 other ancestors2022: 2 other ancestors2021: 6 other ancestors2019: 9 other ancestors2014: 42 other ancestors2013: 39 other ancestors2011: 60 other ancestors2010: 58 other ancestors, 1 with a Class I recall12009: 62 other ancestors2006: 50 other ancestors2001: 50 other ancestors2000: 38 other ancestors2020: 8 other ancestors2017: 22 other ancestors2008: 89 other ancestors, 1 with a Class I recall12007: 47 other ancestors2005: 66 other ancestors2004: 69 other ancestors2003: 47 other ancestors1998: 26 other ancestors1997: 17 other ancestors2002: 40 other ancestors1999: 26 other ancestors1996: 16 other ancestors1995: 19 other ancestors1994: 8 other ancestors1993: 5 other ancestors1978: 1 other ancestor1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1992: 10 other ancestors1990: 4 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors1980: 1 other ancestor1979: 1 other ancestor2026: 2 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K072120 (2007), K073291 (2008) K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×2: 2 generations cleared close together, K141217 (2014), K143163 (2015) ×2: 2 generations cleared close together, K153782 (2016), K161230 (2016) ×2: 2 generations cleared close together, K170962 (2017), K171633 (2017) ×6: 6 generations cleared close together, K180480 (2018), K181453 (2018), K182746 (2018), K183705 (2019), K191311 (2019), K192938 (2019) ×2: 2 generations cleared close together, K203056 (2020), K203742 (2021) K214006 · Invictus® Spinal Fixation System · Alphatec Spine, Inc. · 2022K221926 · Invictus® Bone Cement, Invictus Spinal Fixation System · Alphatec Spine, Inc. · 2022K232275 · Invictus® Spinal Fixation System · Alphatec Spine, Inc. · 202319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 21 other ancestors3 generations back: 61 other ancestors4 generations back: 117 other ancestors, 1 with a Class I recall15 generations back: 158 other ancestors6 generations back: 182 other ancestors7 generations back: 201 other ancestors8 generations back: 151 other ancestors, 1 with a Class I recall19 generations back: 92 other ancestors10 generations back: 41 other ancestors11 generations back: 16 other ancestors12 generations back: 14 other ancestors13 generations back: 1 other ancestor14 generations back: 3 other ancestors 1 generation forward: 2 descendants K232275 · Invictus® Spinal Fixation System · Alphatec Spine, Inc. · 2023K221926 · Invictus® Bone Cement, Invictus Spinal Fixation System · Alphatec Spine, Inc. · 2022K214006 · Invictus® Spinal Fixation System · Alphatec Spine, Inc. · 2022K203742 · IdentiTi ALIF Standalone Interbody System · Alphatec Spine, Inc. · 2021K203056 · Invictus™ Spinal Fixation System · Alphatec Spine, Inc. · 2020K192938 · Invictus™ Spinal Fixation System · Alphatec Spine, Inc. · 2019K191311 · ATEC Lateral Interbody System · Alphatec Spine, Inc. · 2019K183705 · IdentiTi Porous Ti Interbody System · Alphatec Spine, Inc. · 2019K182746 · ATEC ALIF and LLIF Spacer System · Alphatec Spine, Inc. · 2018K181453 · ATEC ALIF Spacer System · Alphatec Spine, Inc. · 2018K180480 · ATEC Universal Spacer System · Alphatec Spine, Inc. · 2018K171633 · NuVasive TLX Interbody System · Nu Vasive, Incorporated · 2017K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 2017K161230 · NuVasive Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−30−25−20−15−10−50
  1. Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 28 generations between
  3. 3 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
  4. 2 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
  5. 1 generation backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
  6. This deviceK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
  7. Descendant · cites it directly · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK253615 Invictus Bands SystemAlphatec Spine, Inc. · 2026
Show all 32 generations
  1. Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 31 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 30 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 29 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 28 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 27 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 26 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 25 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 24 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 23 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 22 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 21 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 20 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 19 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 18 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 17 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 16 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 15 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 14 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 13 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. 12 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  22. 11 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
  23. 10 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
  24. 9 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
  25. 8 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  26. 7 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
  27. 6 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
  28. 5 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
  29. 4 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
  30. 3 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
  31. 2 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
  32. 1 generation backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
  33. This deviceK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010
  • K073202 Ardis Spacer8 generations back · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · cites it directly0descendants
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−32K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−31K990148Stackable Cage SystemDepuy Motech Acromed1999—
−30K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−29K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−28K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−27K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−26K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−25K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−24K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−23K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−22K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−21K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−20K121683Acculif TL CageCoalign Innovations, Inc.2012—
−19K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−18K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−17K141217Acculif TL and PL CageStryker Corporation20143
−16K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−15K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−14K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−13K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
−12K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017—
−11K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018—
−10K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018—
−9K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018—
−8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
−7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.2019—
−6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2019—
−5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2020—
−4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.2021—
−3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.2022—
−2K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.2022—
−1K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.2023—
0 (this device)K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.2024—
+1K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation…Alphatec Spine, Inc.2026—
+1K253615Invictus Bands SystemAlphatec Spine, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198010
198420
198520
198620
198710
198820
198910
199040
1992100
199350
199480
1995190
1996160
1997170
1998260
1999260
2000380
2001500
2002400
2003470
2004690
2005660
2006500
2007470
2008891
2009620
2010581
2011600
2012360
2013390
2014420
2015370
2016240
2017220
2018170
201990
202080
202160
202220
202310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202620
FIG. 1 — Lineage of K241519, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

2 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 NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K232275Invictus® Spinal Fixation System
Summary page 4
…Device: 510(k) Product Name Product Code Clearance Date NKB, KWP, KWQ, K232275 Invictus® Spinal Fixation System September 27, 2023…
Alphatec Spine, Inc.2023—
*K223181NuVasive Reline System
Summary page 4
…PML, OUR Additional Predicate Devices: 510(k) Product Name Product Code Clearance Date K223181 NuVasive Reline System NKB, KWP, KWQ January 11, 2023…
Nu Vasive, Incorporated2023—
*K161363Arsenal Spinal Fixation System
Summary page 4
…Date K223181 NuVasive Reline System NKB, KWP, KWQ January 11, 2023 NKB, OSH, MNI, K161363 Arsenal™ Spinal Fixation System June 10, 2016…
Alphatec Spine, Inc.2016—
*K113395Revere 4.5 Stabilization System
Summary page 4
…June 10, 2016 MNH, KWP MNH, MNI, KWQ, K113395 REVERE 4.5 Stabilization System June 14, 2012…
Globus Medical, Inc.2012—
*K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
Summary page 4
…n System June 14, 2012 KWP, NKB, OSH Response Spine System, Response K181390 5.5/6.0 Spine System, Response NKB, KWP September 18, 2018 4.5/5.0 Spine Syste…
OrthoPediatrics Corp.2018—
*K192938Invictus™ Spinal Fixation System
Summary page 4
…esponse Spine System, Response K181390 5.5/6.0 Spine System, Response NKB, KWP September 18, 2018 4.5/5.0 Spine System K192938 Invictus® Spinal Fixation System NKB, KWP December 12, 2019…
Alphatec Spine, Inc.2019—
*K152968Arsenal Spinal Fixation System
Summary page 6
…Invictus® Small Stature Spinal Fixation System (K232275), and additional predicates NuVasive Reline System (K223181) and Arsenal Spinal Fixation System (K152968). The technological design features of the subject implants were compared to the predicates in intended use, indic…
Alphatec Spine, Inc.2015—

Also cleared against K232275: 6 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260
K253615Invictus Bands SystemAlphatec Spine, Inc.20260

Has anything in its family been recalled? (2 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
  • 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 40 years and passes through 13 companies; a new generation was cleared every 9 months on median.
  • 121 of the 1,095 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K261284 (Alphatec Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K232275.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The Invictus® Small Stature Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis…

Read the full statement (171 words)

The Invictus® Small Stature Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Invictus® Small Stature Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus® Small Stature Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus® Small Stature Spinal Fixation System is intended to be used with autograft and/or allograft.

Indications for use as stated in the FDA summary.

Also cleared against K232275

6 other devices cite the same predicate.

  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026
  • K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
  • K240951Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024

More from Alphatec Spine, Inc.

96 FDA decisions under this applicant name. See the company

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K241519 · printed Nov 5, 2026

Cite this page

510(k) Report. “K241519: Invictus® Small Stature Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241519

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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