Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew, Inc. — Predicate Candidate Screening
532 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
214 days90th percentile
532clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knot | Smith & Nephew, Inc. | 2026-07-09 | 28 | 0 |
| DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | 2026-07-06 | 318 | 0 |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 | 109 | 0 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 | 89 | 0 |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2025-10-03 | 88 | 0 |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (co | Smith & Nephew, Inc. | 2025-06-25 | 28 | 0 |
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025-06-12 | 202 | 0 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 | 27 | 0 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 | 30 | 0 |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2024-12-09 | 41 | 0 |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024-11-20 | 250 | 0 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024-10-30 | 51 | 0 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Aceta | Smith & Nephew, Inc. | 2024-10-21 | 214 | 0 |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024-10-07 | 59 | 0 |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nai | Smith & Nephew, Inc. | 2024-09-20 | 255 | 0 |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | 2024-08-22 | 62 | 0 |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2024-06-27 | 140 | 0 |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAI | Smith & Nephew, Inc. | 2024-06-20 | 30 | 0 |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024-03-18 | 62 | 0 |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | 2024-03-13 | 90 | 0 |
| K233396 | Cannulated Screw System | Smith & Nephew, Inc. | 2023-12-21 | 79 | 0 |
| K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023-10-27 | 56 | 0 |
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX Wi | Smith & Nephew, Inc. | 2023-08-09 | 89 | 0 |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); H | Smith & Nephew, Inc. | 2023-08-04 | 29 | 0 |
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023-07-19 | 62 | 1 |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | 2023-06-14 | 86 | 0 |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-07 | 98 | 0 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni K | Smith & Nephew, Inc. | 2023-05-04 | 56 | 1 |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Smith & Nephew, Inc. | 2023-03-30 | 30 | 0 |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB | Smith & Nephew, Inc. | 2023-02-17 | 143 | 0 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 | 286 | 0 |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022-12-08 | 66 | 0 |
| K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | 2022-11-14 | 592 | 4 |
| K222653 | JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | Smith+Nephew, Inc. | 2022-10-28 | 57 | 0 |
| K213123 | EVOS Wrist Spanning Plate | Smith & Nephew, Inc. | 2022-10-18 | 386 | 0 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-L | Smith & Nephew, Inc. | 2022-09-29 | 367 | 0 |
| K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | 2022-08-25 | 65 | 0 |
| K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022-08-18 | 139 | 0 |
| K221939 | Cemented Round Patella with JRNY Pegs | Smith & Nephew, Inc. | 2022-07-26 | 25 | 0 |
| K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022-07-01 | 437 | 1 |
| K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | 2022-04-26 | 29 | 0 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder Sy | Smith & Nephew, Inc. | 2022-03-11 | 93 | 0 |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022-02-11 | 60 | 0 |
| K211330 | R3 Large Head Liners | Smith & Nephew, Inc. | 2022-01-19 | 261 | 0 |
| K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021-10-01 | 161 | 0 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 | 125 | 0 |
| K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | 2021-08-17 | 77 | 0 |
| K210953 | SMART Taylor Spatial Frame | Smith & Nephew, Inc. | 2021-07-29 | 121 | 0 |
| K203175 | POLARSTEM Cemented Femoral Stem | Smith & Nephew, Inc. | 2021-07-22 | 269 | 0 |
| K211548 | POLARSTEM Calcar Reamer Guide | Smith & Nephew, Inc. | 2021-07-19 | 61 | 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