510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110354Substantially Equivalent

4.5Mm Va-Lcp Curved Condylar Plate System

Synthes (USA) Products LLC, West Chester PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110354 is the FDA 510(k) clearance record for 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM, a class II device, cleared for Synthes USA on under FDA product code JDP (Condylar Plate Fixation Implant). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 2 recalls naming K110354.

Clearance record

Decision date
Received
(25 days to decision)
Product code
JDP Condylar Plate Fixation Implant
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes USA 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDP

Trailing 12 months

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

FDA records show no clearances under product code JDP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDP, 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