Porous Patella— 510(k) K212941

Name: FDA 510(k) clearance K212941
Creator: U.S. Food and Drug Administration
Published: 2022-01-20

Substantially Equivalent

Encore Medical, L.P. Dba Djo Surgical

FDA 510(k) clearance K212941 for Porous Patella, Substantially Equivalent on 2022-01-20. Applicant: Encore Medical, L.P. Dba Djo Surgical. Device class: 2.

Clearance details

Applicant: Encore Medical, L.P. Dba Djo Surgical
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2021-09-15
Decision date: 2022-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBH

view all

K261462 — LANDMARK Total Knee System2026-09-08
K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K212941

K-number listed on FDA's recall record

Z-1384-2023 — EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108Class II·Ongoing·Encore Medical, LP·20230228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212941.

Data sourced from openFDA. This site is unofficial and independent of the FDA.