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FDA 510(k)

Porous Patella

K-Number: K212941 · 2022-01-20

ApplicantEncore Medical, L.P. Dba Djo Surgical
Decision Date2022-01-20
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Porous Patella is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical, L.P. Dba Djo Surgical. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212941. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Porous Patella?

Porous Patella is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Encore Medical, L.P. Dba Djo Surgical. The 510(k) number is K212941.

When did Porous Patella receive FDA 510(k) clearance?

Porous Patella received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212941.

Who is the listed applicant for Porous Patella?

The FDA 510(k) record lists Encore Medical, L.P. Dba Djo Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Porous Patella?

The FDA product code for Porous Patella is MBH.

Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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