# Stryker Spine

- Location (FDA's records): Allendale, NJ
- FDA decisions: 76 (1996–2026): 75 510(k) clearances and 1 original PMA approval
- Product codes: NKB (22), MQP (8), MNI (7), KWP (7), MAX (6), ODP (6), KWQ (6), MNH (4), MQV (2), GXZ (1), PLR (1), FST (1)
- 510(k) review time since 2016: median 90 days, against 96 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 364 (135 its own); citations of its devices by later devices: 413 (135 its own)
- Recalls linked to its devices: 49 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 52 (https://510kreport.com/company/howmedica-osteonics)
- Stryker Corp.: 40 (https://510kreport.com/company/stryker)
- K2m, Inc.: 31 (https://510kreport.com/company/k2m)
- Medtronic Sofamor Danek: 17 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes Spine: 8 (https://510kreport.com/company/synthes-spine)
- Depuy Motech: 7 (https://510kreport.com/company/depuy-motech)
- Osteonics Corp.: 7 (https://510kreport.com/company/osteonics)
- Depuy Spine, Inc.: 7 (https://510kreport.com/company/depuy-spine)

## Firms that cite its devices most
- Stryker Corp.: 58 (https://510kreport.com/company/stryker)
- Spinevision S.A.: 12 (https://510kreport.com/company/spinevision)
- Kalitec Direct, LLC: 10 (https://510kreport.com/company/kalitec-direct)
- Spinecraft, LLC: 9 (https://510kreport.com/company/spinecraft)
- L&K BIOMED Co., Ltd.: 7 (https://510kreport.com/company/l-k-biomed)
- Spineart: 6 (https://510kreport.com/company/spineart)
- Corentec Co., Ltd.: 6 (https://510kreport.com/company/corentec)
- Biomet Spine: 5 (https://510kreport.com/company/biomet-spine)

## Its most-cited devices
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation (1996), cited by 38
- K071373: Stryker Spine Xia Iii Spinal System (2007), cited by 24
- K113666: Xia 3 Spinal System (2012), cited by 21
- K060361: Xia Spinal System, Xia 4.5 Spinal System (2006), cited by 19
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX (2008), cited by 18
- K102606: Avs Anchor-C Cervical Cage System (2011), cited by 17

## Recent decisions
- 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 (Jul 17, 2026)
- K261008: Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute (Apr 24, 2026)
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (Nov 7, 2024)
- K242280: Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips (Aug 29, 2024)
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (Jun 8, 2023)
- 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 (Feb 14, 2023)
- K203205: Navigated Spine Instruments (Mar 23, 2021)
- K200666: Stryker Xia 3 Power Adaptor (Apr 23, 2020)

Source page: https://510kreport.com/company/stryker-spine