Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QHE — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
236 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260802 | Materialise Shoulder System™, Materialise Shoulder Guide and | Materialise NV | 2026-06-09 | 90 | 0 |
| K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-06-04 | 28 | 0 |
| K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 | 22 | 0 |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026-01-12 | 236 | 0 |
| K243509 | Archer PSI System | 3D-Side | 2025-05-12 | 181 | 0 |
| K241470 | CORE Shoulder System | LinkBio Corp. | 2025-02-20 | 272 | 1 |
| K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025-01-21 | 29 | 0 |
| K242813 | Materialise Shoulder System™, Materialise Shoulder Guide and | Materialise NV | 2024-10-18 | 30 | 0 |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024-10-02 | 163 | 0 |
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024-08-05 | 231 | 0 |
| K241143 | Materialise Shoulder System™, Materialise Shoulder Guide and | Materialise NV | 2024-05-22 | 27 | 0 |
| K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 | 123 | 0 |
| K233408 | Materialise Shoulder System™, Materialise Shoulder Guide and | Materialise NV | 2023-11-09 | 34 | 0 |
| K231112 | Materialise Shoulder System™, Materialise Shoulder Guide and | Materialise NV | 2023-09-12 | 146 | 0 |
| K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-06-22 | 83 | 0 |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-03-08 | 244 | 0 |
| K230315 | Materialise Shoulder System™ Materialise Shoulder Guide and | Materialise NV | 2023-03-06 | 28 | 0 |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022-12-20 | 133 | 0 |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and | Materialise NV | 2022-08-17 | 181 | 0 |
| K212569 | Materialise Shoulder System™, Materialise Shoulder Guide and | Materialise NV | 2022-01-12 | 149 | 0 |
| K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021-10-12 | 60 | 0 |
| K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2021-02-03 | 184 | 0 |
| K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020-12-28 | 123 | 0 |
| K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020-06-05 | 88 | 0 |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase | Materialise NV | 2020-03-20 | 88 | 0 |
| K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-30 | 28 | 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