510(k) · Cleared
ClearedInvictus Bands System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Mar 25, 2026 as substantially equivalent to K213659 (Medicrea International SA, 2022) and 2 other predicates after a 127-day review. Its family tree reaches back 33 generations to 1984. 2 of the 1,111 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 25, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 33 generations to K841189 (1984). 1,110 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 2 of the 1,111 devices in this family, counting this one, have a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- 1 generation backK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
- This deviceK253615 Invictus Bands SystemAlphatec Spine, Inc. · 2026
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 15 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 14 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 13 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 12 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 11 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 10 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 9 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 8 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 7 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 6 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 5 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 4 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 3 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- 1 generation backK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
- This deviceK253615 Invictus Bands SystemAlphatec 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 |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −15 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −14 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −13 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −12 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −11 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −10 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −9 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −8 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −7 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −6 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −5 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −4 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −2 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| −1 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
| 0 (this device) | K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026 | — |
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 | 11 | 0 |
| 1993 | 6 | 0 |
| 1994 | 8 | 0 |
| 1995 | 19 | 0 |
| 1996 | 16 | 0 |
| 1997 | 18 | 0 |
| 1998 | 26 | 0 |
| 1999 | 26 | 0 |
| 2000 | 38 | 0 |
| 2001 | 50 | 0 |
| 2002 | 40 | 0 |
| 2003 | 47 | 0 |
| 2004 | 69 | 0 |
| 2005 | 66 | 0 |
| 2006 | 51 | 0 |
| 2007 | 47 | 0 |
| 2008 | 90 | 1 |
| 2009 | 63 | 0 |
| 2010 | 58 | 1 |
| 2011 | 61 | 0 |
| 2012 | 37 | 0 |
| 2013 | 40 | 0 |
| 2014 | 43 | 0 |
| 2015 | 37 | 0 |
| 2016 | 25 | 0 |
| 2017 | 23 | 0 |
| 2018 | 18 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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.
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 OWI device
- #1 K261374 LigaPASS™ Systemscore 17.4 · 21 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 |
|---|---|---|---|
| * | K213659 | LigaPASS™ 2.0 Ligament Augmentation SystemSummary page 5…imary Predicate Device: 510(k) Product Name Product Code Clearance Date LigaPASS™ 2.0 Ligament Augmentation K213659 OWI May 24, 2022 System… | 2022 |
| * | K232275 | Invictus® Spinal Fixation SystemSummary page 5…510(k) Product Name Product Code Clearance Date NKB, KWP, K232275 Invictus® Spinal Fixation System KWQ, OUR, September 27, 2023… | 2023 |
| * | K241519 | Invictus® Small Stature Spinal Fixation SystemSummary page 5…, September 27, 2023 PML Invictus® Small Stature Spinal Fixation NKB, KWP, K241519 June 21, 2024 System… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 121 of the 1,110 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K213659.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Invictus® Bands System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: • Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; • Spinal reconstructive surgery, incorporated into constructs…
Read the full statement (151 words)
The Invictus® Bands System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
• Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
• Spinal degenerative surgery, as an adjunct to spinal fusions;
• Use with a posterior spinal instrumentation construct when ligament augmentation is needed.
The Invictus® Bands System may also be used in conjunction with other medical implants made of commercially pure titanium, titanium alloy, or cobalt chrome whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253615: Invictus Bands System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253615
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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