510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K212941Substantially Equivalent

Porous Patella

Encore Medical, L.P. dba Djo Surgical, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212941 is the FDA 510(k) clearance record for Porous Patella, a class II device, cleared for Encore Medical, L.P. Dba Djo Surgical on under FDA product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). FDA records list one 510(k) clearance for Encore Medical, L.P. Dba Djo Surgical. As of , FDA records show one recall naming K212941.

Clearance record

Decision date
Received
(127 days to decision)
Product code
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation
21 CFR 888.3565
Device class
Class II
Review panel
Orthopedic
Applicant
Encore Medical, L.P. Dba Djo Surgical 9800 Metric Blvd., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBH

Trailing 12 months
9 clearances under product code MBH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MBH, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20262
October 20260