510(k) · Cleared
ClearedProw Fusion
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 Oct 16, 2013 as substantially equivalent to K112359 (Nlt Spine, Ltd., 2011) after a 257-day review. Its family tree reaches back 9 generations to 1984. 8 later devices descend from it.
- Decided
- Oct 16, 2013
- Review
- 257 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K841189 (1984). 26 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 2 generations backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- 1 generation backK112359 Prow FusionNlt Spine, Ltd. · 2011
- This deviceK130254 Prow FusionNlt Spine, Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK142023 Luna Interbody SystemBenvenue Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK162431 Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK183560 Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc. · 2019
- Descendant · 4 generations on · 1 of its ownK193172 Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK151654 Prow FusionNlt Spine, Ltd. · 2015
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 2 generations backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- 1 generation backK112359 Prow FusionNlt Spine, Ltd. · 2011
- This deviceK130254 Prow FusionNlt Spine, Ltd. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142023Luna Interbody SystemBenvenue Medical, Inc. · 2014 · cites it directly5descendants
- K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. · 2016 · 2 generations on3descendants
- K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc. · 2019 · 3 generations on2descendants
- K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. · 2020 · 4 generations on1descendant
- K151654Prow FusionNlt Spine, Ltd. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −2 | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | 1 |
| −1 | K112359 | Prow Fusion | Nlt Spine, Ltd. | 2011 | — |
| 0 (this device) | K130254 | Prow Fusion | Nlt Spine, Ltd. | 2013 | — |
| +1 | K142023 | Luna Interbody System | Benvenue Medical, Inc. | 2014 | — |
| +2 | K162431 | Luna 3D Interbody Fusion System | Benvenue Medical, Inc. | 2016 | — |
| +3 | K183560 | Luna 3D GEN2 Interbody Fusion System | Benvenue Medical, Inc. | 2019 | — |
| +4 | K193172 | Luna XD Ti Interbody Fusion System | Benvenue Medical, Inc. | 2020 | — |
| +1 | K151654 | Prow Fusion | Nlt Spine, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K112359 | Prow FusionSummary page 1…fusion device 21 CFR §880.3080 Product Code MAX Predicate Devices NLT Prow Fusion (K1 12359) Intended Use I Indications for Use The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusio… | 2011 |
What descends from it? (8)
3 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 29 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K142023 (Benvenue Medical, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K112359.
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. 2013, 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 Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may…
Read the full statement (161 words)
The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device.
The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130254: Prow Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130254
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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