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 Nov 8, 2011 as substantially equivalent to K090566 (Custom Spine, Inc., 2009) and 1 other predicate after an 84-day review. Its family tree reaches back 8 generations to 1984. 1 of the 627 devices in its family, counting itself, has a Class I recall. 601 later devices descend from it.
- Decided
- Nov 8, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 25 ancestors in all. 601 later devices descend from it, 3 citing it directly. 1 of the 627 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 1 generation backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- This deviceK112359 Prow FusionNlt Spine, Ltd. · 2011
- Descendant · cites it directly · 593 of its ownK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 4 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
Showing 5 of 601 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 601 · See all- K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013 · cites it directly593descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 4 generations on400descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −1 | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | 1 |
| 0 (this device) | K112359 | Prow Fusion | Nlt Spine, Ltd. | 2011 | — |
| +1 | K130820 | Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2013 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +4 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 19 | 0 |
| 2017 | 28 | 0 |
| 2018 | 31 | 0 |
| 2019 | 44 | 0 |
| 2020 | 65 | 0 |
| 2021 | 51 | 1 |
| 2022 | 61 | 0 |
| 2023 | 76 | 0 |
| 2024 | 83 | 0 |
| 2025 | 72 | 0 |
| 2026 | 58 | 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? (2)
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 |
|---|---|---|---|
| * | K090566 | Pathway AvidSummary page 1…fusion device 21 CFR §880.3080 Product Code MAX Predicate Devices " Custom Spine Pathway AVID (K090566) * Integra Spine Vu aPOD (K080822) Intended Use I Indications for Use The Prow Fusion is intended to be used for spinal fusion.… | 2009 |
| * | K080822 | VU Apod Intervertabral Body Fusion DeviceSummary page 1…21 CFR §880.3080 Product Code MAX Predicate Devices " Custom Spine Pathway AVID (K090566) * Integra Spine Vu aPOD (K080822) Intended Use I Indications for Use The Prow Fusion is intended to be used for spinal fusion. The Prow-Fusion Intervertebral b… | 2008 |
What descends from it? (601)
See all 6013 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K130820 (Nu Vasive, Incorporated, 2013) has gone furthest, with 593 descendants of its own.
- 6 other devices also cite its predicate K090566.
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. 2011, 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 intended 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 intended 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 (eg. 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/K112359 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112359: Prow Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112359
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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