Stryker Spine
FDA Regulatory Profile
Stryker Spine appears in FDA public data with 29 recalls — including 1 Class I (most serious) —, 75 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1488-2025, Class II) was initiated on February 28, 2025. Its most recent 510(k) clearance was granted on July 17, 2026.
Summary
- Total Recalls
- 29 (1 Class I)
- 510(k) Clearances
- 75
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1488-2025 | Class II | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. | February 28, 2025 |
| Z-1489-2025 | Class II | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. | February 28, 2025 |
| Z-1490-2025 | Class II | Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. | February 28, 2025 |
| Z-1491-2025 | Class II | Monterey AL Implant Inserter; 22mm; Catalog 48019140. | February 28, 2025 |
| Z-3210-2024 | Class II | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anteri | August 23, 2024 |
| Z-0610-2024 | Class II | LITe Decompression Snake Arm, REF 48080230 | November 1, 2023 |
| Z-2101-2021 | Class II | Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979 | May 18, 2021 |
| Z-2100-2021 | Class II | Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 | May 18, 2021 |
| Z-1437-2021 | Class II | Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inser | March 11, 2021 |
| Z-0092-2019 | Class II | AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacer | August 13, 2018 |
| Z-0828-2016 | Class II | Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker S | December 18, 2015 |
| Z-0852-2016 | Class II | AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses h | December 16, 2015 |
| Z-0270-2016 | Class II | Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional suppo | September 25, 2015 |
| Z-0222-2016 | Class II | Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Referen | September 8, 2015 |
| Z-0803-2015 | Class II | Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Use | October 6, 2014 |
| Z-2627-2014 | Class II | Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria produc | July 7, 2014 |
| Z-2626-2014 | Class II | Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. | July 7, 2014 |
| Z-1086-2014 | Class II | Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the N | December 18, 2013 |
| Z-0375-2014 | Class II | Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manuf | September 24, 2013 |
| Z-1976-2013 | Class I | Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows fo | May 30, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; | July 17, 2026 |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Sub | April 24, 2026 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal S | November 7, 2024 |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Sub | August 29, 2024 |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, | June 8, 2023 |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tr | February 14, 2023 |
| K203205 | Navigated Spine Instruments | March 23, 2021 |
| K200666 | Stryker Xia 3 Power Adaptor | April 23, 2020 |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar C | July 25, 2019 |
| K183071 | VLIFT-s Vertebral Body Replacement System | January 10, 2019 |
| K181014 | Tritanium PL Cage | July 18, 2018 |
| K171496 | Tritanium C Anterior Cervical Cage | September 6, 2017 |
| K161407 | Ascential IBD PEEKc Spacer | July 15, 2016 |
| K152532 | AERO -C Cervical Cage System | December 18, 2015 |
| K133188 | MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND | December 17, 2013 |
| K132968 | UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) | November 18, 2013 |
| K122845 | ES2 SPINAL SYSTEM MODEL 48280XXXX | December 7, 2012 |
| K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | November 1, 2012 |
| K120869 | ANCHOR-L LUMBAR CAGE | October 25, 2012 |
| K113666 | XIA 3 SPINAL SYSTEM | August 28, 2012 |