510(k) · Cleared
Recalled · Class II · 2016Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 31, 2016 as substantially equivalent to K113285 (Ldr Spine USA, Inc., 2012) and 6 other predicates after a 115-day review. Its family tree reaches back 18 generations to 1984. 1 of the 356 devices in its family, counting itself, has a Class I recall. 189 later devices descend from it. It has been recalled once.
- Decided
- Mar 31, 2016
- Review
- 115 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 18 generations to K841189 (1984). 166 ancestors in all. 189 later devices descend from it, 5 citing it directly. 1 of the 356 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- This deviceK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016
- Descendant · cites it directly · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 2 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- Descendant · 3 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 5 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 5 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 4 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- This deviceK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 189 · See all- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · cites it directly161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 2 generations on116descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 3 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 4 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 5 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −5 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −2 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −1 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| 0 (this device) | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | — |
| +1 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +2 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| +3 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +4 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +5 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 21 | 0 |
| 2005 | 15 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 24 | 1 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 23 | 0 |
| 2024 | 37 | 0 |
| 2025 | 36 | 0 |
| 2026 | 31 | 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 |
|---|---|---|---|
| * | K113285 | LDR Spine Usa Avenue L Interbody FusionSummary page 10…the subject 510(k) was to expand the indications to include use with allograft in the lumbar spine. Predicate Devices: Primary Predicate: Avenue® L Lateral Lumbar Cage (K113285) Avenue® T TLIF Cage (K142645) ROI-A® ALIF Cage System (K110327) ROI-T® Implant System (K082262) Additional Predicates: Orthofix… | 2012 |
| * | K142645 | Avenue T TLIF CageSummary page 10…nd the indications to include use with allograft in the lumbar spine. Predicate Devices: Primary Predicate: Avenue® L Lateral Lumbar Cage (K113285) Avenue® T TLIF Cage (K142645) ROI-A® ALIF Cage System (K110327) ROI-T® Implant System (K082262) Additional Predicates: Orthofix FORZA® Spacer System (K152475… | 2015 |
| * | K110327 | LDR Spine Roi-a Interbody Fusion SystemSummary page 10…with allograft in the lumbar spine. Predicate Devices: Primary Predicate: Avenue® L Lateral Lumbar Cage (K113285) Avenue® T TLIF Cage (K142645) ROI-A® ALIF Cage System (K110327) ROI-T® Implant System (K082262) Additional Predicates: Orthofix FORZA® Spacer System (K152475) Centinel Spine STALIF TT™, STALI… | 2011 |
| * | K082262 | LDR Spine Roi Interbody Fusion SystemSummary page 10…ne. Predicate Devices: Primary Predicate: Avenue® L Lateral Lumbar Cage (K113285) Avenue® T TLIF Cage (K142645) ROI-A® ALIF Cage System (K110327) ROI-T® Implant System (K082262) Additional Predicates: Orthofix FORZA® Spacer System (K152475) Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MID… | 2009 |
| * | K152475 | FORZA PTC Spacer System Cleared while this submission was under review Summary page 10…bar Cage (K113285) Avenue® T TLIF Cage (K142645) ROI-A® ALIF Cage System (K110327) ROI-T® Implant System (K082262) Additional Predicates: Orthofix FORZA® Spacer System (K152475) Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ (K150643). Comparison of Technological Characterist… | 2016 |
| * | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiSummary page 10…-T® Implant System (K082262) Additional Predicates: Orthofix FORZA® Spacer System (K152475) Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ (K150643). Comparison of Technological Characteristics The predicate Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF… | 2015 |
| * | K090507 | Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant SystemSummary page 10…ogical Characteristics The predicate Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System and ROI-T Implant System (K113285, K142645, K110327, K090507, and K082262), Orthofix FORZA® Spacer System (K152475) and Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE I… | 2009 |
What descends from it? (189)
See all 1895 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine… | 2016 | 161 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental… | 2021 | 35 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | 2022 | 12 |
| K161173 | Avenue® T TLIF Cage | 2016 | 3 |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2016 | Class II | Z-0045-2017 | Device Design | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 22 of the 166 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K162103 (Choicespine, LP, 2016) has gone furthest, with 161 descendants of its own.
- 4 other devices also cite its predicate K113285.
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. 2016, 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 Avenue® L Lateral Lumbar Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed…
Read the full statement (563 words)
The Avenue® L Lateral Lumbar Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Avenue® T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
When used as a vertebral body replacement device, the ROI-T® Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.
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/K153495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153495
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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