510(k) · Cleared
Recalled · Class II · 2025PILLAR SA Ti Spacer System (82-XXX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 28, 2024 as substantially equivalent to K200052 (Orthofix, Inc., 2020) and 3 other predicates after a 70-day review. Its family tree reaches back 32 generations to 1984. 1 of the 601 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- May 28, 2024
- Review
- 70 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 32 generations to K841189 (1984). 600 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 601 devices in this family, counting this one, has a Class I recall.
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations between
- 3 generations backK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
- 2 generations backK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- 1 generation backK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- This deviceK240749 PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc. · 2024
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 backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 14 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 13 generations backK160955 Tritanium® PL CageStryker · 2016
- 12 generations backK162262 Tritanium® PL CageStryker · 2016
- 11 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 10 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 9 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 6 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 5 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 4 generations backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- 3 generations backK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
- 2 generations backK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- 1 generation backK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- This deviceK240749 PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc. · 2024
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
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 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −14 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −13 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −10 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −9 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −8 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −7 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −6 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −5 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
| −4 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| −3 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022 | — |
| −2 | K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022 | — |
| −1 | K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024 | — |
| 0 (this device) | K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 22 | 0 |
| 2004 | 42 | 0 |
| 2005 | 30 | 0 |
| 2006 | 18 | 0 |
| 2007 | 22 | 0 |
| 2008 | 55 | 1 |
| 2009 | 43 | 0 |
| 2010 | 32 | 0 |
| 2011 | 49 | 0 |
| 2012 | 35 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 28 | 0 |
| 2016 | 29 | 0 |
| 2017 | 22 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code IK200052 PILLAR SA PTC Spacer System MAX IK222732… | 2020 |
| * | K222732 | WaveForm A Interbody SystemSummary page 4…Product Code IK200052 PILLAR SA PTC Spacer System MAX IK222732 WaveForm A Interbody System MAX IK082235… | 2022 |
| * | K082235 | Blackstone Pillar XL Peek SpacersSummary page 4…MAX IK222732 WaveForm A Interbody System MAX IK082235 PILLAR AL Spacer System MAX IDevice Descripti… | 2008 |
| * | K233694 | Meridian Interbody System; WaveForm A Interbody SystemSummary page 5…od of fixation, surgical approach, sterilization, materials and general design elements as the cited PILLAR SA PTC Spacer System (K200052) and Meridian Interbody System (K233694) predicate devices. In addition, Orthofix conducted the following mechanical tests as detailed in FDA Guidance "Class II Special… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2025 | Class II | Z-2555-2025 | Labeling design | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. |
| Feb 20, 2025 | Class II | Z-1432-2025 | Labeling Change Control | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. |
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 40 years and passes through 17 companies; a new generation was cleared every 8 months on median.
- 66 of the 600 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K200052.
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. 2024, 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 PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).…
Read the full statement (195 words)
The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with 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/K240749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240749: PILLAR SA Ti Spacer System (82-XXX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240749
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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