# K201585: Monterey AL Interbody System - Pathway: 510(k) (Traditional) - Applicant: Stryker Corporation - Decided: Aug 10, 2020 after 60 days - Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar) - Device class: 2 - Regulation: 21 CFR 888.3080 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 23 generations back to K841189 (1984). 422 ancestors in all. 4 later devices descend from it; 2 cite it directly. 0 of 427 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K151481: Sahara Stabilization System, K2m, Inc. (2015) Summary page 5. - K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 5. - K120869: Anchor-L Lumbar Cage, Stryker Spine (2012) Summary page 5. - K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 5. - K181014: Tritanium PL Cage, Stryker Spine (2018) Summary page 5. - K160955: Tritanium® PL Cage, Stryker (2016) Summary page 5. - K152304: Tritanium PL Cage, Stryker (2015) Summary page 5. - K173476: Tritanium® TL Curved Posterior Lumbar Cage, Stryker (2018) Summary page 5. - K200613: Tritanium® X TL Expandable Curved Posterior Lumbar Cage, Stryker Corporation (2020) Summary page 5. - K183249: Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine (2019) Summary page 5. - K170157: INDEPENDENCE® Spacers, Globus Medical, Inc. (2017) Summary page 5. - K150673: SYNFIX Evolution Secured Spacer System, Synthes (USA) Products, LLC (2015) Summary page 5. - K200002: Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device, 4Web, Inc. (2020) Summary page 5. - K171496: Tritanium C Anterior Cervical Cage, Stryker Spine (2017) Summary page 5. ## Most influential descendants - K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (2025), 1 descendant of its own - K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own - K262061: Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (2026), 0 descendants of its own - K252982: CONDUIT™ ZERO-P™ VA Secured Spacer System (2026), 0 descendants of its own ## Recalls of this device - Feb 28, 2025 · Class II · Z-1491-2025: Potential for the gold unlock button to separate from the inserter. - Feb 28, 2025 · Class II · Z-1490-2025: Potential for the gold unlock button to separate from the inserter. - Feb 28, 2025 · Class II · Z-1489-2025: Potential for the gold unlock button to separate from the inserter. - Feb 28, 2025 · Class II · Z-1488-2025: Potential for the gold unlock button to separate from the inserter. ## Indications for use 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. Source page: https://510kreport.com/device/K201585 Methodology: https://510kreport.com/methodology