Atlas FDA

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

Synthes USA · Predicate Candidate Screening

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

77 daysmedian FDA review time
211 days90th percentile
411clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEMSynthes USA2015-03-302940
K131984SYNTHES SYNSONIC ULNA NAILSynthes (Usa)2014-03-312760
K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTSynthes USA2012-07-06350
K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMSynthes USA2012-06-18890
K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROSynthes USA2012-05-08610
K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMSynthes USA2012-03-21720
K120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)Synthes USA2012-02-08280
K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSSynthes (Usa)2011-12-051741
K111540SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEMSynthes (Usa)2011-08-08670
K110789SYNTHES STERNAL ZIPFIX SYSTEMSynthes (Usa)2011-07-281283
K1105923.7MM/5.0MM DYNAMIC LOCKING SCREWSynthes USA2011-07-251452
K1101252.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEMSynthes USA2011-04-21930
K1103544.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEMSynthes USA2011-03-04252
K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEMSynthes (Usa)2011-03-021452
K1032432.4MM VA-LCP INTERCARPAL FUSION SYSTEMSynthes (Usa)2011-01-21811
K102656SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEMSynthes (Usa)2010-12-20960
K093299SYNTHES ORTHODONTIC BONE ANCHOR SYSTEMSynthes (Usa)2010-12-164210
K1026942.4MM VA-LCP DORSAL DISTAL RADIUS PLATESSynthes (Usa)2010-12-09802
K100776SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSynthes (Usa)2010-08-031380
K100634SYNTHES MATRIX SYSTEMSynthes (Usa)2010-07-011180
K092190SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITHSynthes (Usa)2010-05-112941
K092812SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLSynthes (Usa)2010-05-112390
K093361SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)2010-04-141680
K100676SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALLSynthes (Usa)2010-04-08290
K093928SYNTHES 3.5MM QUADRILATERAL SURFACE PLATESSynthes (Usa)2010-03-29970
K093668SYNTHES MATRIX MIS RODSSynthes (Usa)2010-03-091020
K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONALSynthes (Usa)2010-03-033561
K093464RAPIDSORB PLUS SCREW SYSTEMSynthes (Usa)2010-01-25800
K092909SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS Synthes (Usa)2010-01-111110
K092929SYNTHES MATRIX SYSTEMSynthes (Usa)2009-12-29971
K091644SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATESSynthes (Usa)2009-12-232020
K091233SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATESSynthes (Usa)2009-12-112280
K092556SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RASynthes (Usa)2009-11-17891
K092609SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING CSynthes (Usa)2009-11-17840
K090605CLAMPFIXSynthes (Usa)2009-11-062450
K092247SYNTHES LOCKING HAND PLATESSynthes (Usa)2009-09-25590
K092646SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREWSynthes (Usa)2009-09-25280
K091144SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATESSynthes (Usa)2009-08-251270
K090949SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWSSynthes (Usa)2009-07-311190
K091689SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MMSynthes (Usa)2009-07-10300
K090241SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)Synthes (Usa)2009-06-171350
K082649SYNTHES 90 DEGREE SCREWDRIVERSynthes (Usa)2009-04-302300
K090047SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEMSynthes (Usa)2009-04-01840
K083388SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEMSynthes (Usa)2009-03-121151
K083694SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PSynthes (Usa)2009-03-06842
K083573SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATESSynthes (Usa)2009-03-04910
K083439SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEMSynthes (Usa)2009-02-05770
K083025SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEMSynthes (Usa)2009-01-14960
K083213SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESSynthes (Usa)2008-12-30600
K082625SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATESynthes (Usa)2008-12-17991

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