510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K201364Substantially Equivalent

LINK TrabecuLink Femoral Cones

Waldemar Link GmbH & Co. KG, Norderstedt, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201364 is the FDA 510(k) clearance record for LINK TrabecuLink Femoral Cones, a class II device, cleared for Waldemar Link GmbH & Co. KG on under FDA product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). FDA records list 43 510(k) clearances for Waldemar Link GmbH & Co. KG, from to . As of , FDA records show no recalls naming K201364.

Clearance record

Decision date
Received
(56 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
Waldemar Link GmbH & Co. KG Ostsraße 4-10, Norderstedt, DE
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