Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Mako Surgical Corporation · Predicate Candidate Screening

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

114 daysmedian FDA review time
372 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142530Partial Knee Application (PKA)Mako Surgical Corporation2015-09-163720
K150410RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corporation2015-03-20300
K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMMako Surgical Corporation2014-11-131141
K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMMako Surgical Corporation2013-12-10750
K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation2012-06-06616
K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation2012-03-011844
K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation2009-06-17864
K082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEMMako Surgical Corporation2008-11-281192

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