Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Materialise NV — Predicate Candidate Screening

61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time

259 days90th percentile

61clearances 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
K251964	Mimics Thoracic Planner	Materialise NV	2026-03-12	259	0
K253308	Materialise Personalized Guides and Models for Craniomaxillo	Materialise NV	2026-01-07	100	0
K253793	Materialise TKA Guide System	Materialise NV	2026-01-06	39	0
K251554	Materialise TKA Guide System	Materialise NV	2025-07-14	54	0
K243637	Materialise Personalized Guides and Models for Craniomaxillo	Materialise NV	2025-02-21	88	0
K242813	Materialise Shoulder System™, Materialise Shoulder Guide and	Materialise NV	2024-10-18	30	0
K223427	Mimics Enlight CMF	Materialise NV	2024-05-31	564	0
K241143	Materialise Shoulder System™, Materialise Shoulder Guide and	Materialise NV	2024-05-22	27	0
K233217	Mimics Cardiac Planner	Materialise NV	2024-02-12	137	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
K230315	Materialise Shoulder System™ Materialise Shoulder Guide and	Materialise NV	2023-03-06	28	0
K220452	Materialise Shoulder SystemTM Materialise Shoulder Guide and	Materialise NV	2022-08-17	181	0
K221337	Materialise TKA Guide System	Materialise NV	2022-07-05	57	1
K213684	SurgiCase Viewer	Materialise NV	2022-06-15	205	0
K212569	Materialise Shoulder System™, Materialise Shoulder Guide and	Materialise NV	2022-01-12	149	0
K202207	Materialise PKA Guide System	Materialise NV	2020-10-02	57	0
K193560	Materialise Shoulder Guide and Models, Materialise SurgiCase	Materialise NV	2020-03-20	88	0
K190286	Materialise Glenoid Positioning System	Materialise NV	2019-07-08	147	0
K190874	Materialise Mimics Enlight	Materialise NV	2019-06-05	62	0
K183105	Mimics Medical	Materialise NV	2019-03-27	139	0
K173039	TruMatch CMF Titanium 3D Printed Implant	Materialise NV	2018-07-10	285	0
K173970	Materialise PKA Guide System	Materialise NV	2018-07-06	189	0
K173619	Mimics inPrint	Materialise NV	2018-03-21	119	0
K173445	Materialise TKA Guide System	Materialise NV	2018-02-02	88	1
K172650	Materialise PKA Guide System	Materialise NV	2017-11-20	76	0
K172054	Materialise Glenoid Positioning System	Materialise NV	2017-11-03	120	0
K170272	TruMatch CMF Titanium 3D Printed Implant System	Materialise NV	2017-08-08	190	0
K170893	Materialise Glenoid Positioning System	Materialise NV	2017-06-19	84	0
K170419	SurgiCase Viewer	Materialise NV	2017-05-11	87	0
K163156	SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides	Materialise NV	2017-01-18	69	0
K162273	Materialise TKA Guide System	Materialise NV	2016-11-07	87	0
K153602	Materialise Glenoid Positioning System	Materialise NV	2016-04-26	131	0
K150780	Acetabular Cup Orientation System	Materialise NV	2015-10-27	216	0
K150928	Materialise TKA Guide System, Materialise TKA Planner, Mater	Materialise NV	2015-08-10	126	0
K140027	ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER	Materialise NV	2014-05-22	136	0
K132290	SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE	Materialise NV	2014-04-10	261	0
K140257	SIGNATURE PLANNER, SIGNATURE GUIDES	Materialise NV	2014-04-02	58	0
K133162	ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT S	Materialise NV	2014-02-25	131	0
K131559	MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTE	Materialise NV	2013-09-27	120	0
K121640	ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM	Materialise NV	2012-12-05	184	1
K112389	SURGICASE CONNECT, SURGICASE GUIDE	Materialise NV	2012-07-20	337	0
K111863	SIGNATURE PLANNER,SIGNATURE GUIDES	Materialise NV	2012-06-15	351	0
K113599	SURGICASE CONNECT	Materialise NV	2012-04-27	144	0
K113829	ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPE	Materialise NV	2012-04-02	97	0
K111558	SURGICASE GUIDE	Materialise NV	2012-03-27	298	0
K112301	ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER	Materialise NV	2012-01-06	149	0
K111492	ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMME	Materialise NV	2011-10-13	135	2
K111641	SURGICASE ORTHOGNATHIC SOFTWARE WIZARD	Materialise NV	2011-09-26	105	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