510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994146Substantially Equivalent

Epf-Plus Cementless Press-Fit Acetabular Cup

Plus Orthopedics, Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994146 is the FDA 510(k) clearance record for EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP, a class II device, cleared for Plus Orthopedics on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 43 510(k) clearances for Plus Orthopedics, from to . As of , FDA records show no recalls naming K994146.

Clearance record

Decision date
Received
(369 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
Plus Orthopedics 200 Gregory Ln., Pleasant Hill CA
510(k) summary
Summary
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