| ProPlan CMF | SD900.362 | FDA UDI | Class I | Active |
| Lima PSI | KNM-LM01-01-01 | FDA UDI | Class II | Unknown |
| Mimics Automatic Algorithms | CMF CBCT | FDA UDI | Class II | Active |
| Zimmer Biomet Patient Specific Instruments | KNC-ZB02-00-02 | FDA UDI | Class II | Active |
| Lima PSI | SHC-LM02-01-01 | FDA UDI | Class II | Unknown |
| ProPlan CMF | SD900.367 | FDA UDI | Class I | Active |
| ProPlan CMF | SD900.331 | FDA UDI | Class I | Active |
| ProPlan CMF | SD900.339 | FDA UDI | Class I | Active |
| Mimics Flow | Mimics Flow | FDA UDI | Class I | Active |
| ProPlan CMF | SD900.105 | FDA UDI | Class I | Active |
| ProPlan CMF | SD900.109 | FDA UDI | Class II | Active |
| Zimmer Biomet Patient Specific Instruments | KNM-ZB02-00-01 | FDA UDI | Class II | Active |
| Zimmer Biomet Patient Specific Instruments | KNM-ZB06-00-01 | FDA UDI | Class II | Active |
| ProPlan CMF | SD900.009 | FDA UDI | Class II | Unknown |
| Materialise Personalized Solutions | O-01-0-306000-0011-010 | FDA UDI | Class II | Active |
| ProPlan CMF | SD900.202 | FDA UDI | Class I | Active |
| Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla | K133162 | FDA 510(k) | Class II | Active |
| Materialise TKA Guide System | K253793 | FDA 510(k) | Class II | Active |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | K233408 | FDA 510(k) | Class II | Active |
| Zimmer Patient Specific Instruments/ System/Planner | K140027 | FDA 510(k) | Class II | Active |
| TruMatch CMF Titanium 3D Printed Implant System | K170272 | FDA 510(k) | Class II | Active |
| Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35) | K091263 | FDA 510(k) | Class II | Active |
| Materialise Glenoid Positioning System | K153602 | FDA 510(k) | Class II | Active |
| Materialise Mimics Enlight | K190874 | FDA 510(k) | Class II | Active |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | K253308 | FDA 510(k) | Class II | Active |
| Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | K132290 | FDA 510(k) | Class II | Active |
| Surgicase Connect, Surgicase Guide | K112389 | FDA 510(k) | Class II | Active |
| SurgiCase Viewer | K170419 | FDA 510(k) | Class II | Active |
| Mimics Enlight CMF | K223427 | FDA 510(k) | Class II | Active |
| Materialise PKA Guide System | K172650 | FDA 510(k) | Class II | Active |
| Surgicase Guide | K111558 | FDA 510(k) | Class II | Active |
| Materialise Glenoid Positioning System | K172054 | FDA 510(k) | Class II | Active |
| Zimmer Patient Specific Instruments System, Version 2.0 | K093533 | FDA 510(k) | Class II | Active |
| Surgicase | K073449 | FDA 510(k) | Class II | Active |
| Match Point System(tm), Surgicase Connect, Match Point System(tm) Guides | K131559 | FDA 510(k) | Class II | Active |
| Mimics inPrint | K173619 | FDA 510(k) | Class II | Active |
| Materialise PKA Guide System | K202207 | FDA 510(k) | Class II | Active |
| Signature Planner; Signature Guides | K102795 | FDA 510(k) | Class II | Active |
| Acetabular Cup Orientation System | K150780 | FDA 510(k) | Class II | Active |
| Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | K150928 | FDA 510(k) | Class II | Active |
| Materialise TKA Guide System | K162273 | FDA 510(k) | Class II | Active |
| Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | K193560 | FDA 510(k) | Class II | Active |
| Mimics Medical | K183105 | FDA 510(k) | Class II | Active |
| Mimics | K073468 | FDA 510(k) | Class II | Active |
| SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | K163156 | FDA 510(k) | Class II | Active |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | K243637 | FDA 510(k) | Class II | Active |
| Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | K230315 | FDA 510(k) | Class II | Active |
| Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments | K111492 | FDA 510(k) | Class II | Active |
| Surgicase Orthognathic Software Wizard | K111641 | FDA 510(k) | Class II | Active |
| Signature Planner / Signature Guides | K110415 | FDA 510(k) | Class II | Active |