Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Corp. — Predicate Candidate Screening
124 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
231 days90th percentile
124clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230045 | HipCheck | Stryker Corp. | 2023-09-29 | 266 | 0 |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | 2019-07-12 | 63 | 0 |
| K182359 | HipCheck | Stryker Corp. | 2018-12-13 | 105 | 0 |
| K143399 | Stryker Footed Attachments and Cutting Accessories | Stryker Corp. | 2015-05-08 | 161 | 1 |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachmen | Stryker Corp. | 2015-04-23 | 155 | 6 |
| K150449 | LITe Plate System | Stryker Corp. | 2015-03-20 | 28 | 0 |
| K142381 | Xia 3 Spinal System | Stryker Corp. | 2014-10-21 | 56 | 0 |
| K133671 | ICONIX ALL SUTURE ANCHORS | Stryker Corp. | 2014-02-28 | 91 | 0 |
| K122113 | MEMORY METAL STAPLES, EASYCLIP | Stryker Corp. | 2013-03-12 | 238 | 0 |
| K122053 | SHAPEMATCH CUTTING GUIDE | Stryker Corp. | 2012-10-24 | 103 | 1 |
| K122284 | HOFFMANN 3 | Stryker Corp. | 2012-10-24 | 86 | 0 |
| K121252 | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | Stryker Corp. | 2012-07-25 | 91 | 0 |
| K120824 | 3.9MM REELX STT SUTURE ANCHOR SYSTEM | Stryker Corp. | 2012-07-18 | 121 | 0 |
| K121342 | XIA 4.5 SPINAL SYSTEM | Stryker Corp. | 2012-06-22 | 49 | 0 |
| K113327 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | Stryker Corp. | 2012-03-29 | 140 | 2 |
| K120434 | POWER ADAPTOR INSTRUMENT ACCESSORY | Stryker Corp. | 2012-03-08 | 24 | 0 |
| K111786 | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | Stryker Corp. | 2012-01-26 | 216 | 0 |
| K112926 | AXSOS LOCKING PLATE SYSTEM | Stryker Corp. | 2011-12-19 | 77 | 0 |
| K111848 | EXETER X3 RIMFIT ACETABULAR CUP | Stryker Corp. | 2011-10-05 | 98 | 0 |
| K110807 | ABG II MONOLITHIC HIP STEM | Stryker Corp. | 2011-05-25 | 63 | 0 |
| K110533 | STRYKER PATIENT SPECIFIC CUTTING GUIDE | Stryker Corp. | 2011-05-19 | 84 | 1 |
| K110476 | AXSOS (TM) LOCKING PLATE SYSTEM | Stryker Corp. | 2011-03-18 | 28 | 0 |
| K103479 | NOVEL TAPERED HIP STEM | Stryker Corp. | 2011-03-10 | 104 | 0 |
| K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 49 | Stryker Corp. | 2011-01-14 | 106 | 0 |
| K093206 | ORTHOMAP 3D 1.1 MODULE | Stryker Corp. | 2010-08-04 | 295 | 0 |
| K093864 | AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX | Stryker Corp. | 2010-03-11 | 84 | 0 |
| K093704 | AVS PL PEEK SPACERS | Stryker Corp. | 2009-12-23 | 22 | 0 |
| K091606 | VERTAPLEX HV (SINGLE PACK AND DUAL PACK) | Stryker Corp. | 2009-10-23 | 142 | 0 |
| K090816 | STRYKER SPINE AVS PL PEEK SPACERS | Stryker Corp. | 2009-04-24 | 30 | 0 |
| K090166 | AVS ANTERIOR LARGE PEEK SPACERS | Stryker Corp. | 2009-04-22 | 90 | 0 |
| K083020 | STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING | Stryker Corp. | 2009-03-26 | 168 | 0 |
| K083562 | STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM | Stryker Corp. | 2009-03-25 | 113 | 0 |
| K083661 | AVS TL PEEK SPACERS | Stryker Corp. | 2009-02-27 | 79 | 0 |
| K082813 | STRYKER LED LIGHTSOURCE | Stryker Corp. | 2008-12-19 | 86 | 1 |
| K080052 | STRYKER ESSX WITH NAVIGATION MOUNT | Stryker Corp. | 2008-10-02 | 268 | 0 |
| K082014 | STRYKER SPINE AVS PL PEEK SPACERS | Stryker Corp. | 2008-07-28 | 13 | 0 |
| K080450 | STRYKER POWER TOOL NAVIGATOR ATTACHMENT | Stryker Corp. | 2008-07-17 | 149 | 0 |
| K080758 | AVS PL PEEK SPACERS, MODELS 48351 AND 48353 | Stryker Corp. | 2008-03-27 | 9 | 0 |
| K072271 | STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE | Stryker Corp. | 2007-12-18 | 125 | 0 |
| K072118 | STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT | Stryker Corp. | 2007-12-07 | 128 | 0 |
| K073151 | MANTIS SPINAL SYSTEM | Stryker Corp. | 2007-12-06 | 28 | 0 |
| K063480 | STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 | Stryker Corp. | 2007-05-22 | 186 | 0 |
| K070368 | TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL | Stryker Corp. | 2007-05-04 | 85 | 0 |
| K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV | Stryker Corp. | 2006-09-28 | 115 | 0 |
| K061225 | STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS | Stryker Corp. | 2006-09-14 | 135 | 0 |
| K060061 | STRYKER INJECTABLE CEMENT | Stryker Corp. | 2006-03-01 | 51 | 0 |
| K042405 | PAINPUMP1; PAINPUMP2 | Stryker Corp. | 2004-10-14 | 41 | 70 |
| K041754 | STRYKER MAESTRO SYSTEM | Stryker Corp. | 2004-09-07 | 70 | 0 |
| K032945 | SIMPLEX X | Stryker Corp. | 2004-05-25 | 246 | 1 |
| K040764 | STRYKER T4 HYTREL ZIPPER TOGA | Stryker Corp. | 2004-04-27 | 33 | 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