Atlas FDA

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

Joimax GmbH — Predicate Candidate Screening

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

83 daysmedian FDA review time
335 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203014EndoLIF Delta-Cage and DoubleWedge-CageJoimax GmbH2021-09-013350
K192663Joimax Intracs SystemJoimax GmbH2020-07-303090
K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH2019-12-18830
K170358joimax Endovapor 2Joimax GmbH2017-04-21740
K161378joimax Electrosurgical InstrumentsJoimax GmbH2016-11-021680
K151143EndoLIF On-CageJoimax GmbH2015-07-09710
K051827JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPJoimax GmbH2005-08-12370

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