Chrysalis Intelligence · Sponsors · Stryker Spine

Stryker Spine

Allendale, NJ, US · 8 510(k) clearances · 9 recalls

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Total clearances
8
2020-04-23 → 2026-07-17
Last 12 months
2
Product codes
5
Most recent
2026-07-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 2 2026-07-17
MQV Filler, Bone Void, Calcium Compound Class II Orthopedic 2 2026-04-24
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 2 2023-06-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 1 2024-11-07
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2021-03-23
Safety

Recalls (9)

Class I (serious)
0
Risk of injury / death
Total recalls
9
Currently ongoing
6
Most recent
2025-02-28
DateSeverityStatusRecall # ProductCodeReason
2025-02-28 Class II Ongoing Z-1491-2025 Monterey AL Implant Inserter; 22mm; Catalog 48019140. — Potential for the gold unlock button to separate from the inserter.
2025-02-28 Class II Ongoing Z-1490-2025 Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. — Potential for the gold unlock button to separate from the inserter.
2025-02-28 Class II Ongoing Z-1489-2025 Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. — Potential for the gold unlock button to separate from the inserter.
2025-02-28 Class II Ongoing Z-1488-2025 Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. — Potential for the gold unlock button to separate from the inserter.
2024-08-23 Class II Ongoing Z-3210-2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbod… — Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadve…
2023-11-01 Class II Ongoing Z-0610-2024 LITe Decompression Snake Arm, REF 48080230 — Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
2021-05-18 Class II Terminated Z-2101-2021 Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979 — The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-05-18 Class II Terminated Z-2100-2021 Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 — The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-03-11 Class II Terminated Z-1437-2021 Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL … — Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod,…
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-07-17 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 ODP Class II Orthopedic
2026-04-24 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 MQV Class II Orthopedic
2024-11-07 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 KWQ Class II Orthopedic
2024-08-29 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 MQV Class II Orthopedic
2023-06-08 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 NKB Class II Orthopedic
2023-02-14 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 ODP Class II Orthopedic
2021-03-23 K203205 Navigated Spine Instruments OLO Class II Neurology
2020-04-23 K200666 Stryker Xia 3 Power Adaptor NKB Class II Orthopedic
Data source: openFDA · Generated 2026-07-28 09:33 · Last ingest 2026-07-28T13:32:44.564635 · Pipeline: Chrysalis Intelligence