510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051844Substantially Equivalent

Equator Plus Acetabular Cup System

Portland Orthopaedics Pty., Ltd., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051844 is the FDA 510(k) clearance record for EQUATOR PLUS ACETABULAR CUP SYSTEM, a class II device, cleared for Portland Orthopaedics Pty. , Ltd. on under FDA product code MAY (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish). FDA records list 6 510(k) clearances for Portland Orthopaedics Pty. , Ltd., from to . As of , FDA records show no recalls naming K051844.

Clearance record

Decision date
Received
(92 days to decision)
Product code
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Portland Orthopaedics Pty. , Ltd. P.O. Box 560, Stillwater MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAY

Trailing 12 months

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

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