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

Medartis AG · Predicate Candidate Screening

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

90 daysmedian FDA review time
162 days90th percentile
42clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05880
K260934TITAN Nail; APTUS K-Wire SystemMedartis AG2026-04-17280
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026-03-16980
K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG2025-03-071050
K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG2024-06-201070
K232105APTUS Foot System 2.8-3.5Medartis AG2024-04-192800
K234062APTUS Hand Scaphoid PlatesMedartis AG2024-03-21900
K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Medartis AG2023-11-03980
K232144Sterile Products of the APTUS SystemMedartis AG2023-08-18300
K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG2023-06-02580
K223853Medartis APTUS® Ulna PlatesMedartis AG2023-03-30970
K202589APTUS Cannulated Compression Screws, APTUS headed CannulatedMedartis AG2020-11-06591
K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG2020-03-26900
K193639APTUS® Foot 2.8-3.5 SystemMedartis AG2020-03-26900
K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG2020-02-16580
K192984APTUS Clavicle SystemMedartis AG2020-01-24910
K192297APTUS Wrist Arthrodesis PlatesMedartis AG2019-11-08770
K191848APTUS Wrist Spanning Plates 2.5Medartis AG2019-09-30820
K191636APTUS Foot SystemMedartis AG2019-08-16580
K181009APTUS CMC-I Fusion Plate SystemMedartis AG2018-08-241290
K181425APTUS® Proximal Humerus SystemMedartis AG2018-08-05660
K172170APTUS(R) Wrist 2.5 SystemMedartis AG2017-09-08520
K161861APTUS® Coronoid 2.0Medartis AG2017-02-092180
K142906APTUS Wrist 2.5 SystemMedartis AG2015-06-092460
K142581APTUS Foot SystemMedartis AG2015-04-092060
K141232APTUS ULNA SHORTENING 2.5Medartis AG2014-06-23411
K133460APTUS CANNULATED COMPRESSION SCREWSMedartis AG2013-12-18360
K120108APTUS PROXIMAL HUMERUS SYSTEMMedartis AG2012-04-271050
K112169APTUS WRIST ARTHRODESIS PLATESMedartis AG2012-01-061620
K112560APTUS(R) DISTAL HUMERUS SYSTEMMedartis AG2011-12-151040
K110908APTUS FOOT 3.5 SYSTEMMedartis AG2011-06-28890
K110658APTUS CANNULATED COMPRESSION SCREWSMedartis AG2011-06-02870
K103332APTUS ULNA PLATESMedartis AG2011-01-24730
K102537APTUS 1.5 TRILOCKMedartis AG2010-12-10980
K092038APTUS K-WIRE SYSTEMMedartis AG2009-09-23790
K091479APTUS FOOT SYSTEMMedartis AG2009-07-13552
K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEMedartis AG2009-07-01850
K090053APTUS 2.0 RADIAL HEAD SYSTEMMedartis AG2009-04-231050
K071612MODUS TRILOCK 2.0/2.3/2.5Medartis AG2007-09-11900
K992683MODUS 2.5 MANDIBULAR TRAUMA SETMedartis AG1999-11-241060
K992682MODUS 2.5 MANDIBULAR RECONSTRUCTION SETMedartis AG1999-11-241060
K992106MODUS SYSTEM SELF-DRILLING SCREWSMedartis AG1999-09-17870

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