510(k) · Cleared
Recalled · Class II · 2025Monterey AL Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Aug 10, 2020 as substantially equivalent to K151481 (K2m, Inc., 2015) and 13 other predicates after a 60-day review. Its family tree reaches back 23 generations to 1984. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 10, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 4
- Predicates
- 14
Its longest line of descent runs back 23 generations to K841189 (1984). 422 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 2 generations backK183249 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL…Stryker Spine · 2019
- 1 generation backK200613 Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation · 2020
- This deviceK201585 Monterey AL Interbody SystemStryker Corporation · 2020
- Descendant · cites it directly · 1 of its ownK250072 CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · 2 generations on · 0 of its ownK262061 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium®…Stryker Spine · 2026
- Descendant · 2 generations on · 0 of its ownK252982 CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK160955 Tritanium® PL CageStryker · 2016
- 3 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 2 generations backK183249 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL…Stryker Spine · 2019
- 1 generation backK200613 Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation · 2020
- This deviceK201585 Monterey AL Interbody SystemStryker Corporation · 2020
Most influential descendants
Showing 4 of 4 · See all- K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025 · cites it directly1descendant
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · cites it directly1descendant
- K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine · 2026 · 2 generations on0descendants
- K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −3 | K181014 | Tritanium PL Cage | Stryker Spine | 2018 | — |
| −2 | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable… | Stryker Spine | 2019 | — |
| −1 | K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Stryker Corporation | 2020 | — |
| 0 (this device) | K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 | — |
| +1 | K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025 | — |
| +1 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +2 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved… | Stryker Spine | 2026 | — |
| +2 | K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 41 | 0 |
| 2005 | 27 | 0 |
| 2006 | 15 | 0 |
| 2007 | 19 | 0 |
| 2008 | 45 | 0 |
| 2009 | 35 | 0 |
| 2010 | 28 | 0 |
| 2011 | 31 | 0 |
| 2012 | 22 | 0 |
| 2013 | 24 | 0 |
| 2014 | 20 | 0 |
| 2015 | 16 | 0 |
| 2016 | 10 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (14)
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 |
|---|---|---|---|
| * | K151481 | Sahara Stabilization SystemSummary page 5…888.3080) Product Code: OVD, MAX Predicate Devices: Primary Predicate: ▪ K2M SAHARA Stabilization System (K151481) Additional Predicates: ▪ Stryker AVS Anchor-L Lumbar Cage System (K14316… | 2015 |
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 5…▪ K2M SAHARA Stabilization System (K151481) Additional Predicates: ▪ Stryker AVS Anchor-L Lumbar Cage System (K143163, K120869) ▪ Centinel Spine STALIF TT (K073109) ▪ Stryker Tritanium® PL… | 2015 |
| * | K120869 | Anchor-L Lumbar CageSummary page 5…SAHARA Stabilization System (K151481) Additional Predicates: ▪ Stryker AVS Anchor-L Lumbar Cage System (K143163, K120869) ▪ Centinel Spine STALIF TT (K073109) ▪ Stryker Tritanium® PL Posterior… | 2012 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 5…Additional Predicates: ▪ Stryker AVS Anchor-L Lumbar Cage System (K143163, K120869) ▪ Centinel Spine STALIF TT (K073109) ▪ Stryker Tritanium® PL Posterior Lumbar Cage (K181014, K160955,… | 2008 |
| * | K181014 | Tritanium PL CageSummary page 5…e System (K143163, K120869) ▪ Centinel Spine STALIF TT (K073109) ▪ Stryker Tritanium® PL Posterior Lumbar Cage (K181014, K160955, K152304) ▪ Stryker Tritanium® TL Posterior Curved Lumbar… | 2018 |
| * | K160955 | Tritanium® PL CageSummary page 5…(K143163, K120869) ▪ Centinel Spine STALIF TT (K073109) ▪ Stryker Tritanium® PL Posterior Lumbar Cage (K181014, K160955, K152304) ▪ Stryker Tritanium® TL Posterior Curved Lumbar Cage (K1… | 2016 |
| * | K152304 | Tritanium PL CageSummary page 5…▪ Centinel Spine STALIF TT (K073109) ▪ Stryker Tritanium® PL Posterior Lumbar Cage (K181014, K160955, K152304) ▪ Stryker Tritanium® TL Posterior Curved Lumbar Cage (K173476) ▪ Stryk… | 2015 |
| * | K173476 | Tritanium® TL Curved Posterior Lumbar CageSummary page 5…PL Posterior Lumbar Cage (K181014, K160955, K152304) ▪ Stryker Tritanium® TL Posterior Curved Lumbar Cage (K173476) ▪ Stryker Tritanium® X PL Expandable Posterior Lumbar Cage; Trita… | 2018 |
| * | K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar CageSummary page 5…▪ Stryker Tritanium® X PL Expandable Posterior Lumbar Cage; Tritanium® X TL Expandable Curved Posterior Lumbar Cage (K200613, K183249) ▪ Globus Independence® Spacers (K170157)… | 2020 |
| * | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Summary page 5…L Expandable Posterior Lumbar Cage; Tritanium® X TL Expandable Curved Posterior Lumbar Cage (K200613, K183249) ▪ Globus Independence® Spacers (K170157) ▪ Synthes SYNFIX Evolution Se… | 2019 |
| * | K170157 | INDEPENDENCE® SpacersSummary page 5…Tritanium® X TL Expandable Curved Posterior Lumbar Cage (K200613, K183249) ▪ Globus Independence® Spacers (K170157) ▪ Synthes SYNFIX Evolution Secured Spacer System (K150673) ▪ 4WEB Ante… | 2017 |
| * | K150673 | SYNFIX Evolution Secured Spacer SystemSummary page 5…K183249) ▪ Globus Independence® Spacers (K170157) ▪ Synthes SYNFIX Evolution Secured Spacer System (K150673) ▪ 4WEB Anterior Spine Truss System – Stand Alone (ASTS-SA) (K200002) ▪… | 2015 |
| * | K200002 | Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceSummary page 5…▪ Synthes SYNFIX Evolution Secured Spacer System (K150673) ▪ 4WEB Anterior Spine Truss System – Stand Alone (ASTS-SA) (K200002) ▪ Stryker Tritanium® C Anterior Cervical Cage (K171496) Device Description: The purpose of th… | 2020 |
| * | K171496 | Tritanium C Anterior Cervical CageSummary page 5…▪ 4WEB Anterior Spine Truss System – Stand Alone (ASTS-SA) (K200002) ▪ Stryker Tritanium® C Anterior Cervical Cage (K171496) Device Description: The purpose of this Traditional 510(k) submission is to introduce the Monter… | 2017 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2025 | Class II | Z-1491-2025 | Device Design | Potential for the gold unlock button to separate from the inserter. |
| Feb 28, 2025 | Class II | Z-1490-2025 | Device Design | Potential for the gold unlock button to separate from the inserter. |
| Feb 28, 2025 | Class II | Z-1489-2025 | Device Design | Potential for the gold unlock button to separate from the inserter. |
| Feb 28, 2025 | Class II | Z-1488-2025 | Device Design | Potential for the gold unlock button to separate from the inserter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 44 of the 422 ancestors have a recall of any class.
- Of its descendants, K250072 (Avalign Technologies, Inc., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
Monterey™ AL Interbody System – Stand-Alone The Stryker Spine Monterey™ AL Interbody System – Stand-Alone (AL Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as back pain of discogenic origin with…
Read the full statement (413 words)
Monterey™ AL Interbody System – Stand-Alone
The Stryker Spine Monterey™ AL Interbody System – Stand-Alone (AL Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.
The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation).
Monterey™ AL Interbody System – Spacer
The Stryker Spine Monterey™ AL Interbody System – Spacer (AL Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.
The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201585: Monterey AL Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201585
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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