Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Instruments — Predicate Candidate Screening
74 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
185 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261544 | Hydro Irrigation System | Stryker Instruments | 2026-06-17 | 40 | 0 |
| K253679 | Hydro Irrigation System | Stryker Instruments | 2026-05-08 | 168 | 0 |
| K252282 | SurgiCount+ System | Stryker Instruments | 2026-03-16 | 237 | 0 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cabl | Stryker Instruments | 2025-09-25 | 91 | 0 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2025-09-09 | 202 | 0 |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe | Stryker Instruments | 2025-05-15 | 111 | 0 |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | Stryker Instruments | 2025-04-15 | 69 | 0 |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments | 2025-03-24 | 94 | 0 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | 2025-03-21 | 88 | 0 |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); | Stryker Instruments | 2025-03-11 | 29 | 0 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 | 119 | 0 |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2024-10-21 | 81 | 0 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 | 163 | 0 |
| K240526 | POWEReam Xia/Serrato | Stryker Instruments | 2024-04-29 | 66 | 0 |
| K232250 | SurgiCount+ System | Stryker Instruments | 2024-01-11 | 167 | 0 |
| K233300 | POWEReam 1/4 Drive | Stryker Instruments | 2023-12-26 | 88 | 0 |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022-12-20 | 55 | 0 |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750 | Stryker Instruments | 2022-12-09 | 108 | 0 |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, V | Stryker Instruments | 2021-06-25 | 60 | 0 |
| K172367 | Stryker Integrated Bipolar Cord and Tubing Sets | Stryker Instruments | 2017-08-22 | 18 | 0 |
| K063005 | STRYKER T6 HOODS AND TOGAS | Stryker Instruments | 2007-03-23 | 172 | 0 |
| K062640 | STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-0 | Stryker Instruments | 2006-12-14 | 99 | 19 |
| K061725 | STRYKER ARIA PNEUMATIC SYSTEM | Stryker Instruments | 2006-10-26 | 129 | 0 |
| K061660 | STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE | Stryker Instruments | 2006-10-10 | 119 | 0 |
| K061835 | STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSAB | Stryker Instruments | 2006-09-08 | 71 | 0 |
| K043442 | STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE | Stryker Instruments | 2005-05-31 | 168 | 0 |
| K050753 | STRYKER DISCMONITOR | Stryker Instruments | 2005-05-18 | 56 | 0 |
| K043466 | PAINPUMP2 | Stryker Instruments | 2005-05-10 | 146 | 72 |
| K050615 | STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007- | Stryker Instruments | 2005-04-21 | 43 | 0 |
| K050535 | STRYKER MMF SCREW | Stryker Instruments | 2005-03-17 | 15 | 0 |
| K043334 | BONE SOURCE HAC RAPID SETTING CEMENT | Stryker Instruments | 2005-02-09 | 68 | 0 |
| K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-04-01 | 48 | 8 |
| K032406 | STRYKER RF ELECTRODES AND CANNULAE | Stryker Instruments | 2004-04-01 | 241 | 3 |
| K040300 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) | Stryker Instruments | 2004-03-03 | 23 | 8 |
| K032303 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-01-16 | 175 | 65 |
| K032473 | DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE | Stryker Instruments | 2003-11-07 | 87 | 3 |
| K032366 | BONESOURCE HAC FAST SETTING CEMENT | Stryker Instruments | 2003-10-30 | 90 | 0 |
| K031659 | UNIVERSAL NEURO SYSTEM | Stryker Instruments | 2003-09-10 | 105 | 0 |
| K032117 | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | Stryker Instruments | 2003-08-08 | 30 | 0 |
| K031249 | MODIFICATION TO STRYKER PAINPUMP | Stryker Instruments | 2003-07-21 | 94 | 0 |
| K030661 | STRYKER PAINPUMP2 | Stryker Instruments | 2003-05-30 | 88 | 3 |
| K030885 | MODIFICATION TO STRYKER PAINPUMP2 | Stryker Instruments | 2003-04-18 | 28 | 0 |
| K030378 | STRYKER LEIBINGER CRANIAL FIXATION SYSTEM | Stryker Instruments | 2003-03-20 | 43 | 0 |
| K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE | Stryker Instruments | 2003-01-22 | 184 | 10 |
| K022185 | UNIVERSAL CMF SYSTEM | Stryker Instruments | 2002-12-17 | 167 | 0 |
| K021440 | BONESOURCE HAC | Stryker Instruments | 2002-08-02 | 88 | 0 |
| K022162 | STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; S | Stryker Instruments | 2002-08-01 | 29 | 0 |
| K014263 | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM | Stryker Instruments | 2002-03-08 | 71 | 1 |
| K012991 | NEPTUNE WASTE MANAGEMENT STSTEM | Stryker Instruments | 2001-11-29 | 84 | 6 |
| K003543 | STRYKER PAINPUMP PCA | Stryker Instruments | 2001-06-05 | 200 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda