510(k) · Cleared
ClearedIntraOp Alignment System; CONTOUR3D Bending System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · SIN Automated Intraoperative Spinal Rod Bending System
Cleared on Jun 25, 2026 as substantially equivalent to K240199 (Alphatec Spine, Inc., 2024) and 1 other predicate after a 269-day review. Its family tree reaches back 32 generations to 1984. 2 of the 1,114 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 25, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- SIN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 32 generations to K841189 (1984). 1,113 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 2 of the 1,114 devices in this family, counting this one, have a Class I recall.
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations between
- 3 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 1 generation backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- This deviceK253216 IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
Show all 32 generations
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 31 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 30 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 29 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 26 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 25 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 22 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 21 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 20 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 19 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 18 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 17 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 16 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 15 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 14 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 13 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 12 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 11 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 10 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 9 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 8 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 7 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 6 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 5 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 4 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 3 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 1 generation backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- This deviceK253216 IntraOp Alignment System; CONTOUR3D Bending 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 |
|---|---|---|---|---|---|
| −32 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −31 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −30 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −29 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −26 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −25 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −22 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −21 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −20 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −19 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −18 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −17 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −16 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −15 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −14 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −13 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −12 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −11 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −10 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −9 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −8 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −7 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −6 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −5 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −3 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −2 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −1 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| 0 (this device) | K253216 | IntraOp Alignment System; CONTOUR3D Bending 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 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 13 | 0 |
| 1993 | 7 | 0 |
| 1994 | 13 | 0 |
| 1995 | 22 | 0 |
| 1996 | 20 | 0 |
| 1997 | 19 | 0 |
| 1998 | 28 | 0 |
| 1999 | 30 | 0 |
| 2000 | 38 | 0 |
| 2001 | 55 | 0 |
| 2002 | 47 | 0 |
| 2003 | 48 | 0 |
| 2004 | 71 | 0 |
| 2005 | 67 | 0 |
| 2006 | 49 | 0 |
| 2007 | 46 | 0 |
| 2008 | 89 | 1 |
| 2009 | 62 | 0 |
| 2010 | 56 | 1 |
| 2011 | 60 | 0 |
| 2012 | 33 | 0 |
| 2013 | 37 | 0 |
| 2014 | 43 | 0 |
| 2015 | 30 | 0 |
| 2016 | 22 | 0 |
| 2017 | 20 | 0 |
| 2018 | 13 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K240199 | IntraOp Alignment SystemSummary page 6…IntraOp Alignment System Primary Predicate: Trade Name: IntraOp Alignment System 510(k) Number: K240199 510(k) Clearance Date: May 22, 2024 Common or Usual Name: Interventional Fluoroscopic X-… | 2024 |
| * | K232275 | Invictus® Spinal Fixation SystemSummary page 6…ONTOUR3D Bending System: Primary Predicate: Trade Name: Invictus Spinal Fixation System 510(k) Number: K232275 510(k) Clearance Date: September 27, 2023 Common or Usual Name: Thoracolumbosacral Pedic… | 2023 |
| † | K230195 | Neo ADVISE software | 2024 |
| † | K192938 | Invictus™ Spinal Fixation System | 2019 |
| † | K161363 | Arsenal Spinal Fixation System | 2016 |
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.
- 128 of the 1,113 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All SIN devicesSIN Automated Intraoperative Spinal Rod Bending System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIN
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIN
Too few SIN 510(k)s in any year since 2007 to give a median.
Recalls per year · SIN
No recall names SIN since 2007.
Adverse event reports per year · SIN
No MAUDE report names SIN since 2007.
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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
IntraOp Alignment System: The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery. The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing, and measuring spinal alignment assessment images at various time points during surgery, as well as planning spinal surgical procedures, including a…
Read the full statement (117 words)
IntraOp Alignment System:
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery.
The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing, and measuring spinal alignment assessment images at various time points during surgery, as well as planning spinal surgical procedures, including a user-defined, patient-specific rod plan during surgery.
The IntraOp Alignment System is intended for adults and pediatrics.
CONTOUR3D Bending System:
The CONTOUR3D Bending System is intended to intraoperatively bend compatible Alphatec spinal rods by generating and executing bending instructions in accordance with a user-defined rod plan and data imported from the IntraOp Alignment System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253216: IntraOp Alignment System; CONTOUR3D Bending System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253216
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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