510(k) · Cleared
ClearedPSX 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 Aug 10, 2021 as substantially equivalent to K183705 (Alphatec Spine, Inc., 2019) and 6 other predicates after a 54-day review. Its family tree reaches back 26 generations to 1984. 1 of the 546 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Aug 10, 2021
- Review
- 54 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 26 generations to K841189 (1984). 534 ancestors in all, the oldest K792352 (1979). 11 later devices descend from it, 2 citing it directly. 1 of the 546 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · cites it directly · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 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 · 3 generations on · 1 of its ownK242147 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc. · 2024
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 11 · See all- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · cites it directly8descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · cites it directly7descendants
- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 2 generations on4descendants
- K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −1 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| 0 (this device) | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +1 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
| +1 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +3 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | 2024 | — |
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 | 53 | 1 |
| 2009 | 40 | 0 |
| 2010 | 28 | 0 |
| 2011 | 35 | 0 |
| 2012 | 24 | 0 |
| 2013 | 30 | 0 |
| 2014 | 26 | 0 |
| 2015 | 19 | 0 |
| 2016 | 13 | 0 |
| 2017 | 9 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 4…LY MARKETED PREDICATE DEVICES 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K183705 MAX IndentiTi Porous Interbody System Alphatec Spine Additional Predicate Devices K… | 2019 |
| * | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Summary page 4…Primary Predicate Device K183705 MAX IndentiTi Porous Interbody System Alphatec Spine Additional Predicate Devices K171848 MAX Globus Rise Spacers Globus Medical K112648 MAX As… | 2017 |
| * | K112648 | Asfora Bullet CageSummary page 4…tem Alphatec Spine Additional Predicate Devices K171848 MAX Globus Rise Spacers Globus Medical K112648 MAX Asfora Bullet Cage System Medical Designs K… | 2012 |
| * | K193203 | MOJAVE Expandable Interbody SystemSummary page 4…K112648 MAX Asfora Bullet Cage System Medical Designs K2M Mojave Expandable K193203 MAX K2M Int… | 2020 |
| * | K160959 | Xsert Lumbar Expandable Interbody SystemSummary page 4…K2M Interbody System Xsert Expandable Interbody K160959 MAX X-Spine Systems… | 2016 |
| * | K090782 | Novel Alif Spinal Spacer SystemSummary page 4…K160959 MAX X-Spine Systems System K090782 MAX, MQP Novel ALIF Spinal Spacer System Alphatec Spine MAX, OVD, K1… | 2009 |
| * | K191311 | ATEC Lateral Interbody SystemSummary page 4…System K090782 MAX, MQP Novel ALIF Spinal Spacer System Alphatec Spine MAX, OVD, K191311 ATEC Lateral Interbody System Alphatec Spine PHM IV. DEVICE… | 2019 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 57 of the 534 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222455 (Alphatec Spine, Inc., 2022) has gone furthest, with 8 descendants of its own.
- 15 other devices also cite its predicate K183705.
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. 2021, 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 PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (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 PSX Interbody System is…
Read the full statement (118 words)
The PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (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 PSX 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 lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211873: PSX Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211873
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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