510(k) · Cleared
ClearedCalibrate LTX Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 18, 2022 as substantially equivalent to K211805 (Alphatec Spine, Inc., 2021) and 4 other predicates after a 95-day review. Its family tree reaches back 28 generations to 1984. 1 of the 588 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Nov 18, 2022
- Review
- 95 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 28 generations to K841189 (1984). 579 ancestors in all, the oldest K792352 (1979). 8 later devices descend from it, 1 citing it directly. 1 of the 588 devices in this family, counting this one, has a Class I recall.
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations between
- 3 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- 1 generation backK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- This deviceK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK242147 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261020 Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK251575 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF…Alphatec Spine · 2025
Show all 28 generations
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 26 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 25 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 22 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 21 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 18 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 17 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 16 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 15 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 14 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 13 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 12 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 11 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 10 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 8 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 7 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 6 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 3 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- 1 generation backK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- This deviceK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · cites it directly7descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 2 generations on4descendants
- K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc. · 2024 · 2 generations on1descendant
- K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026 · 3 generations on0descendants
- K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −27 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −26 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −25 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −22 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −21 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −18 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −17 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −16 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −15 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −14 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −13 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −12 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −11 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −10 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −8 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −6 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −3 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −2 | K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020 | — |
| −1 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
| 0 (this device) | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
| +1 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +2 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +3 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | — |
| +3 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone… | Alphatec Spine | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 12 | 0 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 22 | 0 |
| 2004 | 43 | 0 |
| 2005 | 31 | 0 |
| 2006 | 21 | 0 |
| 2007 | 22 | 0 |
| 2008 | 54 | 1 |
| 2009 | 42 | 0 |
| 2010 | 30 | 0 |
| 2011 | 38 | 0 |
| 2012 | 26 | 0 |
| 2013 | 31 | 0 |
| 2014 | 29 | 0 |
| 2015 | 24 | 0 |
| 2016 | 15 | 0 |
| 2017 | 17 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
1 device in this family has 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Summary page 4…Trade Name Manufacturer Primary Predicate Device MAX, PHM, IdentiTi and Transcend Interbody K211805 Alphatec Spine OVD, ODP… | 2021 |
| * | K211873 | PSX Interbody SystemSummary page 4…Alphatec Spine OVD, ODP Systems Additional Predicate Devices K211873 MAX PSX Interbody System Alphatec Spine K161379 OVD, MAX… | 2021 |
| * | K161379 | ELSA SpacersSummary page 4…Systems Additional Predicate Devices K211873 MAX PSX Interbody System Alphatec Spine K161379 OVD, MAX Globus Medical K191005 MAX… | 2016 |
| * | K191005 | ProLift® Expandable SystemSummary page 4…PSX Interbody System Alphatec Spine K161379 OVD, MAX Globus Medical K191005 MAX Prolift Expandable System Life Spine MAX, PHM, Id… | 2019 |
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 4…1005 MAX Prolift Expandable System Life Spine MAX, PHM, IdentiTi Porous Ti Interbody K183705 Alphatec Spine OVD, ODP… | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223611 | Calibrate LTX Interbody System | 2023 | 7 |
Has anything in its family been recalled? (1 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 63 of the 579 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223611 (Alphatec Spine, Inc., 2023) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K211805.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: L1-L2 to L5-S1, for the…
Read the full statement (177 words)
The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.
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/K222455 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222455: Calibrate LTX Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222455
Report an extraction error
Are you the manufacturer?
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