Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopedic — Predicate Candidate Screening
17,044 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
91 daysmedian FDA review time
268 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-08-07 | 28 | 0 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 | 88 | 0 |
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 | 125 | 0 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpi | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 | 62 | 0 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 | 245 | 0 |
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 | 230 | 0 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 | 46 | 0 |
| K261408 | SABER-XA System | Elevation Spine | 2026-08-03 | 95 | 0 |
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026-07-31 | 60 | 0 |
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-07-31 | 91 | 0 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026-07-31 | 60 | 0 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACT | Globus Medical, Inc. | 2026-07-31 | 30 | 0 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-I | Stryker Endoscopy | 2026-07-30 | 20 | 0 |
| K260624 | Arthrex Radial Head Replacement System | Arthrex, Inc. | 2026-07-30 | 154 | 0 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 | 61 | 0 |
| K261430 | TruLift Expandable System | Life Spine, Inc. | 2026-07-28 | 89 | 0 |
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 | 82 | 0 |
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | 2026-07-24 | 18 | 0 |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 | 226 | 0 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET S | MANTIZ Co., Ltd. | 2026-07-24 | 170 | 0 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 | 58 | 0 |
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026-07-23 | 304 | 0 |
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | 2026-07-22 | 139 | 0 |
| K262094 | E3D™-C Interbody System | Evolution Spine | 2026-07-22 | 30 | 0 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 | 30 | 0 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 | 83 | 0 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 | 63 | 0 |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tri | Stryker Spine | 2026-07-17 | 29 | 0 |
| DEN250040 | SportSuite Vision Software | Stryker Endoscopy | 2026-07-17 | 318 | 0 |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 | 301 | 0 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed No | TriMed, Inc. | 2026-07-16 | 29 | 0 |
| K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026-07-16 | 90 | 0 |
| K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026-07-16 | 86 | 0 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tes | Kyocera Medical Technologies, Inc. | 2026-07-15 | 82 | 0 |
| K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | 2026-07-15 | 314 | 0 |
| K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 | 109 | 0 |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2. | Alphatec Spine, Inc. | 2026-07-14 | 88 | 0 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 | 56 | 0 |
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | 2026-07-10 | 102 | 0 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knot | Smith & Nephew, Inc. | 2026-07-09 | 28 | 0 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 | 86 | 0 |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026-07-08 | 198 | 0 |
| DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | 2026-07-06 | 318 | 0 |
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 | 102 | 0 |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 | 273 | 0 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific | S.M.A.I.O | 2026-07-01 | 215 | 0 |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; | SeaSpine Orthopedics Corporation | 2026-07-01 | 273 | 0 |
| K260556 | Veritas Shoulder System | Restor3D | 2026-07-01 | 132 | 0 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 | 92 | 0 |
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 | 55 | 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