Atlas FDA

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

Zimmer GmbH — Predicate Candidate Screening

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

83 daysmedian FDA review time
180 days90th percentile
43clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K211047CoCr HeadZimmer GmbH2023-01-106420
K200814Affixus(R) Natural Nail(R) System Humeral NailZimmer GmbH2020-04-28290
K200112Zimmer Hip Joint ReplacementZimmer GmbH2020-04-10842
K193099Anatomical Shoulder SystemZimmer GmbH2020-01-29830
K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic ZweymullZimmer GmbH2019-12-26550
K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH2019-12-06370
K192236Fitmore Hip StemZimmer GmbH2019-11-05780
K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2019-10-11460
K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic FeZimmer GmbH2019-10-01270
K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH2019-09-13290
K192021NCB Polyaxial Locking Plate SystemZimmer GmbH2019-08-22240
K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SZimmer GmbH2019-08-06350
K181827Affixus Natural Nail System Humeral NailZimmer GmbH2018-12-141580
K171858Sidus Stem-Free ShoulderZimmer GmbH2017-12-181800
K170711ASHCOM Shoulder System, Anatomical Shoulder System and AnatoZimmer GmbH2017-06-01850
K170072Fitmore® Hip StemZimmer GmbH2017-02-07290
K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH2016-11-011410
K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SysZimmer GmbH2016-07-08720
K160085Anatomical Shoulder System, Anatomical Shoulder Domelock SysZimmer GmbH2016-03-08530
K142403Anatomical Shoulder System/Anatomical Shoulder Domelock SystZimmer GmbH2014-11-24890
K131884AVENIR CEMENTED HIP STEMZimmer GmbH2013-08-22580
K130899BIOLOX DELTA CERAMIC FEMORAL HEADSZimmer GmbH2013-05-01300
K123392AVENIR MULLER STEMZimmer GmbH2013-03-041221
K120715ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - AZimmer GmbH2012-08-101550
K120772NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BZimmer GmbH2012-06-12900
K113556WAGNER CONE PROSTHESIS SYSTEMZimmer GmbH2012-02-17781
K113718NCB STRAIGHT NARROW SHAFT PLATESZimmer GmbH2012-01-27390
K110836CLS BREVIUS STEM WITH KINECTIV TECHNOLOGYZimmer GmbH2011-10-071960
K103404ANA0TOMICAL SHOULDER TM COMBINED SYSTEMZimmer GmbH2011-03-151161
K091003ZIMMER MMC CUPZimmer GmbH2009-11-242300
K091973METASUL TAPER LINERS, METASUL FEMORAL HEADSZimmer GmbH2009-11-171392
K091566ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILSZimmer GmbH2009-10-281532
K081759NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES,Zimmer GmbH2008-10-161181
K073567BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIESZimmer GmbH2008-03-13841
K071723ZIMMER POROLOCK MIS STEMZimmer GmbH2008-03-072561
K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbH2007-04-26853
K062029ANATOMICAL SHOULDER FRACTURE SYSTEMZimmer GmbH2006-10-311053
K061211NCB PLATING SYSTEM, PROXIMAL TIBIA PLATESZimmer GmbH2006-06-14443
K053536DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEZimmer GmbH2006-03-168713
K053274ANATOMICAL SHOULDER INVERSE/REVERSEZimmer GmbH2006-01-25633
K051623ANATOMICAL SHOULDER KEELED GLENOIDZimmer GmbH2005-07-19291
K043270SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 0Zimmer GmbH2005-01-31662
K042695NCB PLATING SYSTEMZimmer GmbH2004-10-29291

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