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FDA 510(k)

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

K-Number: K243571 · 2025-07-31

ApplicantZimmer Biomet
Decision Date2025-07-31
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is a medical device manufactured by Zimmer Biomet. It received FDA 510(k) clearance on 2025-07-31 under approval number K243571. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Zimmer Biomet. The 510(k) number is K243571.

When was Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners approved by the FDA?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners received FDA 510(k) clearance on 2025-07-31, under approval number K243571.

What company makes Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is manufactured by Zimmer Biomet.

What is the FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

The FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is JDI.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05591859 Restoration Anatomic Acetabular Shell Revision Study WITHDRAWN NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING

Other Devices by Zimmer Biomet

K243293Zimmer® Persona® Personalized Knee System K251834Persona Partial Knee K251620A.L.P.S. Proximal Humerus Plating System K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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