510(k) · Cleared
ClearedProw Fusion-V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nlt Spine, Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 11, 2016 as substantially equivalent to K123231 (Globus Medical, Inc., 2013) and 3 other predicates after a 193-day review. Its family tree reaches back 15 generations to 1984. 6 later devices descend from it.
- Decided
- Jul 11, 2016
- Review
- 193 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 133 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- This deviceK153786 Prow Fusion-VNlt Spine, Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK193418 SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 3 of its ownK212540 Explorer TO SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 3 generations on · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
- Descendant · 4 generations on · 0 of its ownK251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable…Expanding Innovations, Inc. · 2025
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- This deviceK153786 Prow Fusion-VNlt Spine, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation · 2020 · cites it directly4descendants
- K212540Explorer TO SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on3descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · 3 generations on2descendants
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 4 generations on0descendants
- K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| 0 (this device) | K153786 | Prow Fusion-V | Nlt Spine, Ltd. | 2016 | — |
| +1 | K193418 | SeaSpine Skipjack System | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K212540 | Explorer TO System | SeaSpine Orthopedics Corporation | 2021 | — |
| +3 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +4 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
| +4 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral… | Expanding Innovations, Inc. | 2025 | — |
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 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 20 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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.
Planning a device in MAX? 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 |
|---|---|---|---|
| * | K123231 | Caliber SpacersSummary page 4…ication: 21 CFR §880.3080 Product Code: MAX Class: II Primary Predicate Device: Globus Medical, CALIBER Spacer (K123231) Additional Predicate devices: SpineSource, Inc. L-Varlock Lumbar Cage (K080537); NuVasive CoRoent System (K141665) Globus Medi… | 2013 |
| * | K080537 | L-VarlockSummary page 4…II Primary Predicate Device: Globus Medical, CALIBER Spacer (K123231) Additional Predicate devices: SpineSource, Inc. L-Varlock Lumbar Cage (K080537); NuVasive CoRoent System (K141665) Globus Medical, RISE Spacer (K113447) Intended Use / Indications for Use… | 2008 |
| * | K141665 | NuVasive CoRoent SystemSummary page 4…y Predicate Device: Globus Medical, CALIBER Spacer (K123231) Additional Predicate devices: SpineSource, Inc. L-Varlock Lumbar Cage (K080537); NuVasive CoRoent System (K141665) Globus Medical, RISE Spacer (K113447) Intended Use / Indications for Use… | 2015 |
| * | K113447 | Rise SpacerSummary page 4…ALIBER Spacer (K123231) Additional Predicate devices: SpineSource, Inc. L-Varlock Lumbar Cage (K080537); NuVasive CoRoent System (K141665) Globus Medical, RISE Spacer (K113447) Intended Use / Indications for Use… | 2012 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 12 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 133 ancestors have a recall of any class.
- Of its descendants, K193418 (SeaSpine Orthopedics Corporation, 2020) has gone furthest, with 4 descendants of its own.
- 23 other devices also cite its predicate K123231.
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?
PROW FUSION-V is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153786: Prow Fusion-V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153786
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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