510(k) · Cleared
ClearedProw Fusion-L
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 Sep 15, 2016 as substantially equivalent to K133717 (Life Spine, 2014) and 9 other predicates after a 269-day review. Its family tree reaches back 17 generations to 1984. 1 of the 225 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 15, 2016
- Review
- 269 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 17 generations to K841189 (1984). 224 ancestors in all. No later device cites it as a predicate yet. 1 of the 225 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK153665 Prow Fusion-LNlt Spine, Ltd. · 2016
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 4 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK153665 Prow Fusion-LNlt Spine, Ltd. · 2016
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −4 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −2 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −1 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| 0 (this device) | K153665 | Prow Fusion-L | Nlt Spine, Ltd. | 2016 | — |
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 | 12 | 0 |
| 2003 | 16 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 7 | 0 |
| 2007 | 14 | 0 |
| 2008 | 29 | 1 |
| 2009 | 21 | 0 |
| 2010 | 16 | 0 |
| 2011 | 14 | 0 |
| 2012 | 10 | 0 |
| 2013 | 12 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 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? (10)
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 |
|---|---|---|---|
| * | K133717 | Longbow Spacer SystemSummary page 4…device Classification Name: Intervertebral body fusion device 21 CFR §880.3080 Product Code MAX Predicate Device Primary predicate: Life Spine, Longbow Spacer System (K133717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Me… | 2014 |
| * | K112359 | Prow FusionSummary page 4…evice 21 CFR §880.3080 Product Code MAX Predicate Device Primary predicate: Life Spine, Longbow Spacer System (K133717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, AR… | 2011 |
| * | K130254 | Prow FusionSummary page 4…CFR §880.3080 Product Code MAX Predicate Device Primary predicate: Life Spine, Longbow Spacer System (K133717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spin… | 2013 |
| * | K151654 | Prow FusionSummary page 4…3080 Product Code MAX Predicate Device Primary predicate: Life Spine, Longbow Spacer System (K133717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System… | 2015 |
| * | K153786 | Prow Fusion-V Cleared while this submission was under review Summary page 4…edicate Device Primary predicate: Life Spine, Longbow Spacer System (K133717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Calib… | 2016 |
| * | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Summary page 4…redicate: Life Spine, Longbow Spacer System (K133717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Caliber (K123231);TranS1 Later… | 2015 |
| * | K132897 | Clydesdale Spinal SystemSummary page 4…3717) Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Caliber (K123231);TranS1 Lateral Intervertebral Fusion Device (K100210) Inten… | 2013 |
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 4…PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Caliber (K123231);TranS1 Lateral Intervertebral Fusion Device (K100210) Intended Use / Indications for Use The PROW F… | 2015 |
| * | K123231 | Caliber SpacersSummary page 4…54, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Caliber (K123231);TranS1 Lateral Intervertebral Fusion Device (K100210) Intended Use / Indications for Use The PROW FUSION-L is intended for spi… | 2013 |
| * | K100210 | TRANS1 Lateral Intervertebral Fusion Device, TSummary page 4…K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Caliber (K123231);TranS1 Lateral Intervertebral Fusion Device (K100210) Intended Use / Indications for Use The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients wi… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 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 12 companies; a new generation was cleared every 11 months on median.
- 23 of the 224 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K133717.
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 PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. 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…
Read the full statement (138 words)
The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. 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). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device. The device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153665: Prow Fusion-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153665
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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