510(k) · Cleared
ClearedTera Lumbar Interbody Fusion System (Various PNs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuity Surgical Devices, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 2, 2025 as substantially equivalent to K221535 (Acuity Surgical Devices, LLC, 2022) and 2 other predicates after a 33-day review. Its family tree reaches back 25 generations to 1984. 1 of the 413 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 2, 2025
- Review
- 33 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 25 generations to K841189 (1984). 411 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 413 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- 2 generations backK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
- 1 generation backK221535 Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC · 2022
- This deviceK251335 Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC · 2025
- Descendant · cites it directly · 0 of its ownK254130 C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc. · 2018 · Recalled
- 3 generations backK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- 2 generations backK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
- 1 generation backK221535 Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC · 2022
- This deviceK251335 Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC · 2025
Class I recalls in this family
- K073202 Ardis Spacer8 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. | 2018 | 1 |
| −3 | K183064 | TxTi IBF System | Innovasis, Inc. | 2019 | 1 |
| −2 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 | 1 |
| −1 | K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | 2022 | — |
| 0 (this device) | K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | — |
| +1 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 19 | 0 |
| 2004 | 28 | 0 |
| 2005 | 21 | 0 |
| 2006 | 16 | 0 |
| 2007 | 18 | 0 |
| 2008 | 49 | 1 |
| 2009 | 34 | 0 |
| 2010 | 26 | 0 |
| 2011 | 31 | 0 |
| 2012 | 22 | 0 |
| 2013 | 26 | 0 |
| 2014 | 21 | 0 |
| 2015 | 14 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K221535 | Align Lumbar Interbody Fusion SystemSummary page 5…Trade Name Manufacturer Primary Predicate Device Align Lumbar Interbody Acuity Surgical Devices K221535 MAX Fusion Device LLC Additional Predicate Devices… | 2022 |
| * | K243386 | Ventris Intervertebral Body Fusion DeviceSummary page 5…Fusion Device LLC Additional Predicate Devices Acuity Surgical Devices K243386 OVD Ventris LLC… | 2025 |
| * | K222561 | AlignSummary page 5…tris LLC Acuity Surgical Devices K222561 OVD Align HA LLC Device Descriptio… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254130 | C.A. Medical Interbody Fusion System | 2026 | 0 |
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 · 8 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 43 of the 411 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K254130 (C.A. Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221535.
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 Tera Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. The Tera Lumbar Interbody Fusion System is intended for use at either one level or two contiguous levels…
Read the full statement (135 words)
The Tera Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion.
The Tera Lumbar Interbody Fusion System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 Tera Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251335: Tera Lumbar Interbody Fusion System (Various PNs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251335
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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