510(k) · Cleared
ClearedPRADO™ Lumbar Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bethesda Medical Devices · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 5, 2025 as substantially equivalent to K141443 (Infront Medical, LLC, 2014) and 2 other predicates after a 29-day review. Its family tree reaches back 33 generations to 1984. 2 of the 1,290 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 5, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 33 generations to K841189 (1984). 1,289 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 2 of the 1,290 devices in this family, counting this one, have a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 2 generations backK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- 1 generation backK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
- This deviceK252113 PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices · 2025
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 15 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 14 generations backK160955 Tritanium® PL CageStryker · 2016
- 13 generations backK162262 Tritanium® PL CageStryker · 2016
- 12 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 11 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 10 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 7 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 6 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 5 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 4 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 3 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 2 generations backK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- 1 generation backK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
- This deviceK252113 PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −15 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −14 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −11 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −10 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −9 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −8 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −7 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −6 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −5 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −4 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| −2 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
| −1 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
| 0 (this device) | K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 4 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 12 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 23 | 0 |
| 1996 | 25 | 0 |
| 1997 | 24 | 0 |
| 1998 | 38 | 0 |
| 1999 | 25 | 0 |
| 2000 | 40 | 0 |
| 2001 | 49 | 0 |
| 2002 | 48 | 0 |
| 2003 | 56 | 0 |
| 2004 | 77 | 0 |
| 2005 | 62 | 0 |
| 2006 | 45 | 0 |
| 2007 | 47 | 0 |
| 2008 | 90 | 1 |
| 2009 | 64 | 0 |
| 2010 | 58 | 1 |
| 2011 | 74 | 0 |
| 2012 | 50 | 0 |
| 2013 | 53 | 0 |
| 2014 | 56 | 0 |
| 2015 | 49 | 0 |
| 2016 | 38 | 0 |
| 2017 | 39 | 0 |
| 2018 | 19 | 0 |
| 2019 | 15 | 0 |
| 2020 | 16 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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.
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 |
|---|---|---|---|
| * | K141443 | Infront Lumbar Interbody Fusion SystemSummary page 5…on Name: Intervertebral Body Fusion Device (21 CFR 888.3080 Class II, Product Code MAX) D. Primary Predicate Device: K141443 (InFront Lumbar Interbody Fusion System) Additional Predicate: K241375 (Transcend PEEK Interbody System)… | 2014 |
| * | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Summary page 5…Product Code MAX) D. Primary Predicate Device: K141443 (InFront Lumbar Interbody Fusion System) Additional Predicate: K241375 (Transcend PEEK Interbody System) K170395 (Talos Intervertebral Body Fusion Devices) E. Devic… | 2025 |
| * | K170395 | Talos® Lumbar (HA) PEEK IBF DevicesSummary page 5…e: K141443 (InFront Lumbar Interbody Fusion System) Additional Predicate: K241375 (Transcend PEEK Interbody System) K170395 (Talos Intervertebral Body Fusion Devices) E. Device Description: PRADO™ Lumbar Interbody Fusion System consists of a series of… | 2017 |
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 41 years and passes through 19 companies; a new generation was cleared every 8 months on median.
- 135 of the 1,289 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K141443.
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. 2025, 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 PRADO™ Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These…
Read the full statement (178 words)
The PRADO™ Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis and/or stenosis at the involved level(s). Additionally, the Prado™ Lumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion.
Additionally, the use of hyperlordotic devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252113: PRADO™ Lumbar Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252113
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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