Atlas FDA

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

Consensus Orthopedics, Inc. — Predicate Candidate Screening

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

114 daysmedian FDA review time
280 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.2017-10-052440
K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.2017-08-092680
K160515PS2 Knee SystemConsensus Orthopedics, Inc.2016-12-192990
K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.2015-03-04650
K133919CONSENSUS VITALITE TIBIAL INSERTConsensus Orthopedics, Inc.2014-07-142030
K141043CS2 MULTI-HOLE ACETABULAR SHELLConsensus Orthopedics, Inc.2014-05-19260
K130652VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTConsensus Orthopedics, Inc.2013-12-172800
K122512CS2 HIP SYSTEMConsensus Orthopedics, Inc.2012-11-05800
K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.2012-10-122270
K121935TAPERSET HIP SMALL STEMSConsensus Orthopedics, Inc.2012-09-10700
K121263TAPER SET HIP SYSTEM RDP STEMConsensus Orthopedics, Inc.2012-05-22260
K110950CONSENSUS KNEE SYSTEMConsensus Orthopedics, Inc.2011-06-27840
K110542CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEADConsensus Orthopedics, Inc.2011-04-01360
K102927CONSENSUS KNEE SYSTEMConsensus Orthopedics, Inc.2011-01-261140
K102399CONSENSUS TAPERSET HIP SYSTEMConsensus Orthopedics, Inc.2010-12-021000
K100933CONSENSUS CS2 PLUS ACETABULAR INSERTConsensus Orthopedics, Inc.2010-10-061840
K100542CONSENSUS REVISION KNEE SYSTEMConsensus Orthopedics, Inc.2010-06-241190

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