510(k) · Cleared
ClearedZSFab Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zsfab, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 14, 2022 as substantially equivalent to K172009 (K2m, Inc., 2017) and 2 other predicates after a 109-day review. Its family tree reaches back 22 generations to 1984. 1 of the 337 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 14, 2022
- Review
- 109 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K841189 (1984). 332 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 2 citing it directly. 1 of the 337 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 1 generation backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- This deviceK221858 ZSFab Lumbar Interbody SystemZsfab, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK242734 ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024
- Descendant · cites it directly · 1 of its ownK252610 ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260549 ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc. · 2026
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 1 generation backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- This deviceK221858 ZSFab Lumbar Interbody SystemZsfab, Inc. · 2022
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 4 of 4 · See all- K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024 · cites it directly3descendants
- K252610ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025 · cites it directly1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 2 generations on0descendants
- K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −2 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −1 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| 0 (this device) | K221858 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2022 | — |
| +1 | K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | 2024 | — |
| +1 | K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025 | — |
| +2 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
| +2 | K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 17 | 0 |
| 2004 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 16 | 0 |
| 2008 | 46 | 1 |
| 2009 | 28 | 0 |
| 2010 | 22 | 0 |
| 2011 | 28 | 0 |
| 2012 | 18 | 0 |
| 2013 | 17 | 0 |
| 2014 | 20 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K172009 | Cascadia Interbody SystemSummary page 4…ystem implants are manufactured from Ti- 6Al-4V ELI titanium alloy (ASTM F3001). Primary Predicate: Cascadia™ Interbody System (K2M Inc. – K172009) Additional Predicates: ZSFab Cervical Interbody System (ZSFab Inc. – K202488), Medtronic ARTiC-L™ 3D… | 2017 |
| * | K202488 | ZSFab Cervical Interbody SystemSummary page 4…anium alloy (ASTM F3001). Primary Predicate: Cascadia™ Interbody System (K2M Inc. – K172009) Additional Predicates: ZSFab Cervical Interbody System (ZSFab Inc. – K202488), Medtronic ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology (Medtronic Sof… | 2021 |
| * | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Summary page 4…Fab Inc. – K202488), Medtronic ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology (Medtronic Sofamor Danek USA, Inc – K190959) K221858 - Page 2 of 2 Performan… | 2019 |
What descends from it? (4)
2 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 38 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 37 of the 332 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242734 (Zsfab, 2024) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K172009.
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 ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is…
Read the full statement (157 words)
The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.
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/K221858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221858: ZSFab Lumbar 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/K221858
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