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

Fusion Orthopedics, LLC — Predicate Candidate Screening

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

162 daysmedian FDA review time
266 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210159IntraLock SystemFusion Orthopedics, LLC2021-07-231830
K193377TopLock Anchor SystemFusion Orthopedics, LLC2020-11-253560
K202959PolyLock Plating SystemFusion Orthopedics, LLC2020-11-24550
K192323PolyLock Small Bone Plating SystemFusion Orthopedics, LLC2019-11-18830
K190136Fusion Silastic SystemFusion Orthopedics, LLC2019-10-212650
K182342IntraLock Lapidus SystemFusion Orthopedics, LLC2019-05-212660
K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC2018-11-23580
K181815DynaBridgeFusion Orthopedics, LLC2018-10-15980
K170624TalarLift STSFusion Orthopedics, LLC2017-08-111620
K170038FuzeFix Screw SystemFusion Orthopedics, LLC2017-08-072140
K161449HammerTech Fixation SystemFusion Orthopedics, LLC2016-10-111390

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