510(k) · Cleared
ClearedInvictus® Bone Cement, Invictus Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · PML Bone Cement, Posterior Screw Augmentation
Cleared on Dec 20, 2022 as substantially equivalent to K103433 (Teknimed, S.A., 2011) and 5 other predicates after a 172-day review. Its family tree reaches back 30 generations to 1984. 2 of the 1,019 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Dec 20, 2022
- Review
- 172 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 30 generations to K841189 (1984). 1,004 ancestors in all, the oldest K781443 (1978). 14 later devices descend from it, 3 citing it directly. 2 of the 1,019 devices in this family, counting this one, have a Class I recall.
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations between
- 3 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 2 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 1 generation backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- This deviceK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK232044 Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
Show all 30 generations
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 28 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 27 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 24 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 23 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 20 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 19 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 18 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 17 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 16 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 15 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 14 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 13 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 12 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 11 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 10 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 9 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 8 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 7 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 6 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 5 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 4 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 3 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 2 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 1 generation backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- This deviceK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · cites it directly11descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 2 generations on4descendants
- K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023 · cites it directly3descendants
- K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024 · 2 generations on2descendants
- K240951Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −30 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −29 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −28 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −27 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −24 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −23 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −20 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −19 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −18 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −17 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −16 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −15 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −14 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −13 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −12 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −11 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −10 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −9 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −8 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −7 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −6 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −5 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −4 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −2 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −1 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| 0 (this device) | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +1 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +1 | K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023 | — |
| +2 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
| +2 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 10 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 18 | 0 |
| 1996 | 16 | 0 |
| 1997 | 17 | 0 |
| 1998 | 25 | 0 |
| 1999 | 26 | 0 |
| 2000 | 37 | 0 |
| 2001 | 47 | 0 |
| 2002 | 40 | 0 |
| 2003 | 46 | 0 |
| 2004 | 69 | 0 |
| 2005 | 63 | 0 |
| 2006 | 48 | 0 |
| 2007 | 45 | 0 |
| 2008 | 87 | 1 |
| 2009 | 60 | 0 |
| 2010 | 54 | 1 |
| 2011 | 54 | 0 |
| 2012 | 29 | 0 |
| 2013 | 33 | 0 |
| 2014 | 37 | 0 |
| 2015 | 26 | 0 |
| 2016 | 19 | 0 |
| 2017 | 16 | 0 |
| 2018 | 12 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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.
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 PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K103433 | F20Summary page 4…EGALLY MARKETED PREDICATE DEVICES 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K103433 NDN F20 Teknimed Additional Predicate Devices K214006… | 2011 |
| * | K214006 | Invictus® Spinal Fixation SystemSummary page 4…er Primary Predicate Device K103433 NDN F20 Teknimed Additional Predicate Devices K214006 NKB, KWP Invictus® Spinal Fixation System Alphatec Spine K200596 PML, NKB G21 Cement, VAD… | 2022 |
| * | K200596 | G21 Cement, VADER® Pedicle SystemSummary page 4…Teknimed Additional Predicate Devices K214006 NKB, KWP Invictus® Spinal Fixation System Alphatec Spine K200596 PML, NKB G21 Cement, VADER Pedicle System Icotec AG NKB, KWP, VIPER PRIME™ Screws,… | 2020 |
| * | K173095 | VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Summary page 4…NKB, KWP, VIPER PRIME™ Screws, VIPER DePuy Synthes KWQ PRIME™ Screws with Fenestrations, K173095 EXPEDIUM® Verse Screws with Fenestrations === Page 5 =… | 2017 |
| * | K212692 | Mariner Pedicle Screw SystemSummary page 5…t, Invictus Spinal Fixation System 510(k) Product Code Trade Name Manufacturer NKB, KWQ, K212692 Mariner Pedicle Screw System SeaSpine KWP K180498 PML, N… | 2021 |
| * | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone CementSummary page 5…Manufacturer NKB, KWQ, K212692 Mariner Pedicle Screw System SeaSpine KWP K180498 PML, NKB, High V+ Bone Cement, NuVasive® NuVasive KWP Reline® Fenestrate… | 2018 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 38 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 116 of the 1,004 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K232275 (Alphatec Spine, Inc., 2023) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K103433.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Invictus 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…
Read the full statement (272 words)
The Invictus 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 pedicle screw fixation in pediatric patients, the Invictus 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 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 Spinal Fixation System is intended to be used with autograft and/or allograft.
Invictus Core and Invictus 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 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 Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221926: Invictus® Bone Cement, Invictus 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/K221926
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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