Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PBF — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
224 daysmedian FDA review time
446 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252064 | MedCAD® AccuStride™ System | Medcad | 2026-03-27 | 269 | 0 |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 2025-12-05 | 270 | 0 |
| K242603 | MyPAO SA guides | Medacta International S.A. | 2025-11-19 | 446 | 0 |
| K251709 | MedCAD® AccuStride™ System | Medcad | 2025-11-04 | 154 | 0 |
| K250394 | Fine TTO™ | Bodycad Laboratories, Inc. | 2025-10-21 | 251 | 0 |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-10-01 | 202 | 0 |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025-06-25 | 90 | 0 |
| K241811 | MedCAD® AccuStride™ System | Medcad | 2025-03-13 | 265 | 0 |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-02-13 | 56 | 0 |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024-11-07 | 269 | 0 |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024-03-18 | 62 | 0 |
| K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024-02-09 | 31 | 0 |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023-10-25 | 509 | 0 |
| K223421 | MedCAD AccuPlan Orthopedics System | Medcad | 2023-09-20 | 314 | 0 |
| K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023-06-02 | 28 | 0 |
| K220706 | MyPAO Guides | Medacta International S.A. | 2023-05-30 | 446 | 0 |
| K221943 | EmbedMed | 3D Lifeprints UK , Ltd. | 2023-02-01 | 211 | 0 |
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) S | Centermed, Inc. | 2022-08-04 | 435 | 0 |
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | 2022-06-28 | 442 | 0 |
| K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022-06-09 | 90 | 0 |
| K212237 | 3D-Cut | 3D-Side S.A. | 2021-11-29 | 133 | 0 |
| K211244 | VSP® Orthopedics System | 3D Systems | 2021-11-10 | 198 | 0 |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2020-03-11 | 139 | 0 |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | 2019-08-21 | 224 | 0 |
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017-01-18 | 69 | 0 |
| K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE | Materialise NV | 2014-04-10 | 261 | 0 |
| K112389 | SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | 2012-07-20 | 337 | 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