510(k) · Cleared
ClearedInvictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 14, 2026 as substantially equivalent to K232275 (Alphatec Spine, Inc., 2023) and 4 other predicates after an 88-day review. Its family tree reaches back 34 generations to 1984. 7 of the 1,597 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 14, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 34 generations to K841189 (1984). 1,596 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 7 of the 1,597 devices in this family, counting this one, have a Class I recall.
- Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations between
- 3 generations backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- 2 generations backK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
- 1 generation backK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- This deviceK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
Show all 34 generations
- Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 33 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 32 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 31 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 30 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 28 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 27 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 26 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 24 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 23 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 22 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 21 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 20 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 19 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 18 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 17 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 16 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 15 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 14 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 13 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 12 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 11 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 10 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 9 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 8 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 7 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 6 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 5 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 4 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 3 generations backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- 2 generations backK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
- 1 generation backK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- This deviceK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −34 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −33 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −32 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −31 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −30 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −28 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −27 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −26 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −24 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −23 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −22 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −21 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −20 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −19 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −18 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −17 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −16 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −15 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −14 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −13 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −12 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −11 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −10 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −9 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −8 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −7 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −6 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −5 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −4 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −3 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| −2 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | — |
| −1 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| 0 (this device) | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 4 | 0 |
| 1989 | 6 | 0 |
| 1990 | 5 | 0 |
| 1991 | 7 | 0 |
| 1992 | 13 | 0 |
| 1993 | 10 | 0 |
| 1994 | 13 | 0 |
| 1995 | 26 | 0 |
| 1996 | 26 | 0 |
| 1997 | 21 | 0 |
| 1998 | 38 | 0 |
| 1999 | 36 | 0 |
| 2000 | 50 | 0 |
| 2001 | 69 | 1 |
| 2002 | 56 | 0 |
| 2003 | 64 | 0 |
| 2004 | 91 | 0 |
| 2005 | 91 | 0 |
| 2006 | 68 | 0 |
| 2007 | 66 | 0 |
| 2008 | 113 | 1 |
| 2009 | 82 | 0 |
| 2010 | 79 | 2 |
| 2011 | 87 | 0 |
| 2012 | 63 | 0 |
| 2013 | 56 | 0 |
| 2014 | 63 | 0 |
| 2015 | 69 | 1 |
| 2016 | 49 | 1 |
| 2017 | 46 | 1 |
| 2018 | 25 | 0 |
| 2019 | 19 | 0 |
| 2020 | 16 | 0 |
| 2021 | 8 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 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.
7 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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K232275 | Invictus® Spinal Fixation SystemSummary page 6…vice: 510(k) Product Name Product Code Clearance Date NKB, KWP, KWQ, K232275 Invictus® Spinal Fixation System September 27, 2023… | 2023 |
| * | K241519 | Invictus® Small Stature Spinal Fixation SystemSummary page 6…Additional Predicate Devices: 510(k) Product Name Product Code Clearance Date Invictus® Small Stature Spinal K241519 NKB, KWP, KWQ June 21, 2024 Fixation System K180337… | 2024 |
| * | K180337 | EUROPA Pedicle Screw SystemSummary page 6…Invictus® Small Stature Spinal K241519 NKB, KWP, KWQ June 21, 2024 Fixation System K180337 EUROPA™ Pedicle Screw System NKB March 14, 2019… | 2019 |
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 7…510(k) Premarket Notification Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems Medtronic Navigated Manual K161210 Reusable Instruments for use with OUR, HWE, OLO August 12, 2016 the StealthStation™ Va… | 2016 |
| * | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Summary page 7…Manual K161210 Reusable Instruments for use with OUR, HWE, OLO August 12, 2016 the StealthStation™ Valence Robotic Navigation K252597 Instruments (for use with OLO February 19, 2026 StealthStation)… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 7 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 8 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 8 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 9 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 9 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 15 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 42 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 210 of the 1,596 ancestors have a recall of any class; 7 have a Class I recall.
- 6 other devices also cite its predicate K232275.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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…
Read the full statement (523 words)
The Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 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 and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System are intended to be used with autograft and/or allograft.
Invictus Small Stature/Invictus 2.0 SI.CORE Screws are intended to be used with Alphatec’s 4.5, 5.0, 5.5 and 6.0 mm diameter rods for sacroiliac joint fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
Invictus Small Stature/Invictus 2.0 CORE and Invictus Small Stature/Invictus 2.0 SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Small Stature and Invictus 2.0 Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Small Stature and Invictus 2.0 Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Invictus 2.0 Navigation Instruments (for Use with StealthStation™)
The Invictus 2.0 Navigation Instruments are intended to be used during the placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures.
Navigation instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
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/K261284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 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/K261284
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026