510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051826Substantially Equivalent

Betacone Hip Prosthesis System

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

K051826 is the FDA 510(k) clearance record for BETACONE HIP PROSTHESIS SYSTEM, a class II device, cleared for Waldemar Link GmbH & Co. KG on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 43 510(k) clearances for Waldemar Link GmbH & Co. KG, from to . As of , FDA records show no recalls naming K051826.

Clearance record

Decision date
Received
(136 days to decision)
Product code
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Waldemar Link GmbH & Co. KG 1835 Market St. 28th Floor, Philadelphia PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LWJ

Trailing 12 months

FDA records hold no clearances under product code LWJ in the trailing twelve months.

FDA records show no clearances under product code LWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260