Atlas FDA

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

Heraeus Medical GmbH — Predicate Candidate Screening

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

87 daysmedian FDA review time
177 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241674OSTEOPAL® VHeraeus Medical GmbH2024-12-051770
K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH2024-02-15570
K222570COPAL knee mouldsHeraeus Medical GmbH2023-02-041650
K220492COPAL exchange G hip spacerHeraeus Medical GmbH2022-03-23290
K213812PALACOS MV proHeraeus Medical GmbH2022-02-02571
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH2021-07-091303
K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALAHeraeus Medical GmbH2020-11-23870
K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH2019-11-011980
K190766PALACOS fast R+GHeraeus Medical GmbH2019-05-31670
K182260PALACOS MVHeraeus Medical GmbH2018-09-17270
K153737OSTEOPAL plusHeraeus Medical GmbH2016-04-221160
K150119PALACOS R proHeraeus Medical GmbH2015-06-171480
K142157PALACOS R+G PROHeraeus Medical GmbH2014-09-05300

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