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

Plus Orthopedics AG — Predicate Candidate Screening

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

120 daysmedian FDA review time
143 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070928CERAMIC BALL HEADS, 28, 32 AND 36 MMPlus Orthopedics AG2007-08-011200
K070731PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEMPlus Orthopedics AG2007-07-311380
K070278POLARCUP DUAL MOBILITY SYSTEMPlus Orthopedics AG2007-04-16770
K063578PROMOS MODULAR SHOULDER SYSTEMPlus Orthopedics AG2007-03-02924
K061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEMPlus Orthopedics AG2006-10-061430

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