Chrysalis Intelligence · Sponsors · Stryker Instruments

Stryker Instruments

Portage, MI, US · 19 510(k) clearances · 1 recalls

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Total clearances
19
2021-06-25 → 2026-06-17
Last 12 months
5
Product codes
13
Most recent
2026-06-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 3 2025-09-09
PBZ Image Processing Device For Estimation Of External Blood Loss Class II General Hospital 2 2026-03-16
OLO Orthopedic Stereotaxic Instrument Class II Neurology 2 2025-09-25
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 2 2024-04-29
NDN Cement, Bone, Vertebroplasty Class II Orthopedic 2 2022-12-20
EOB Nasopharyngoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 1 2026-06-17
GWG — — — 1 2026-05-08
GXI — — — 1 2025-05-15
LFL Instrument, Ultrasonic Surgical Unclassified Unknown 1 2025-03-24
HBE — — — 1 2025-03-11
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2025-01-16
FYA Gown, Surgical Class II General, Plastic Surgery 1 2024-10-16
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered Class II General, Plastic Surgery 1 2022-12-09
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2022-06-24
DateSeverityStatusRecall # ProductCodeReason
2022-06-24 Class II Ongoing Z-1478-2022 Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures. — There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgic…
Filings

All 510(k) clearances (19)

Date K-number Device Code Class Specialty
2026-06-17 K261544 Hydro Irrigation System EOB Class II Ear, Nose, Throat
2026-05-08 K253679 Hydro Irrigation System GWG — —
2026-03-16 K252282 SurgiCount+ System PBZ Class II General Hospital
2025-09-25 K251971 RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer OLO Class II Neurology
2025-09-09 K250483 PhotonBlade 3; PhotonBlade 3 Smoke Evacuation GEI Class II General, Plastic Surgery
2025-05-15 K250213 OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) GXI — —
2025-04-15 K250327 OptaBlate Radiofrequency (RF) Generator System GEI Class II General, Plastic Surgery
2025-03-24 K243930 Sonopet iQ Ultrasonic Aspirator System (5500-050-000) LFL Unclassified Unknown
2025-03-21 K243958 Consolidated Operating Room Equipment (CORE) 2 Console OLO Class II Neurology
2025-03-11 K250374 iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R HBE — —
2025-01-16 K242834 System 9 Sterile Battery Container KCT Class II General Hospital
2024-10-21 K242266 PhotonBlade 3; PhotonBlade 3 Smoke Evacuation GEI Class II General, Plastic Surgery
2024-10-16 K241272 Stryker Steri-Shield 8 Surgical Hoods and Togas FYA Class II General, Plastic Surgery
2024-04-29 K240526 POWEReam Xia/Serrato NKB Class II Orthopedic
2024-01-11 K232250 SurgiCount+ System PBZ Class II General Hospital
2023-12-26 K233300 POWEReam 1/4 Drive NKB Class II Orthopedic
2022-12-20 K223294 SpineJack® Expansion Kit NDN Class II Orthopedic
2022-12-09 K222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) JCX Class II General, Plastic Surgery
2021-06-25 K211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement NDN Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence