Atlas FDA

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

Implantcast GmbH · Predicate Candidate Screening

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

254 daysmedian FDA review time
530 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252451EPORE® XO cup systemImplantcast GmbH2026-04-242630
K260037implantcast Packaging System UpdateImplantcast GmbH2026-03-30830
K252401implaFit® short stemsImplantcast GmbH2026-03-122240
K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH2025-03-102510
K240391MUTARS® femoral stem cemented 160 mm and 200 mmImplantcast GmbH2024-10-242590
K234044ACS® LD FB Knee SystemImplantcast GmbH2024-09-062600
K240834EcoFit® short stem cementless cpTiImplantcast GmbH2024-06-03690
K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH2024-02-162540
K232371Actinia® hip stemsImplantcast GmbH2023-10-19720
K223103BethaLoc® stem cementless HAImplantcast GmbH2023-06-202630
K222482AGILON XO Shoulder SystemImplantcast GmbH2022-09-28420
K210678implaFit® hip stemsImplantcast GmbH2022-08-175300
K203420EcoFit® Hip SystemImplantcast GmbH2021-02-03760
K203341ACS LD Uni FB Knee SystemImplantcast GmbH2021-01-08570
K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH2020-11-125330
K200045MUTARS Cemented Femoral StemsImplantcast GmbH2020-10-162820
K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH2019-08-28760
K181778MUTARS Proximal Femur Replacement SystemImplantcast GmbH2019-03-252650
K180263EcoFit Vit E Acetabular SystemImplantcast GmbH2018-07-201710
K163577Ecofit® Hip SystemImplantcast GmbH2017-09-252791

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