510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150780Substantially Equivalent

Acetabular Cup Orientation System

Materialise N.V., Leuven, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150780 is the FDA 510(k) clearance record for Acetabular Cup Orientation System, a class II device, cleared for Materialise NV on under FDA product code PLW. FDA's definition for product code PLW reads: "The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the...". FDA records list 61 510(k) clearances for Materialise NV, from to . As of , FDA records show no recalls naming K150780.

Clearance record

Decision date
Received
(216 days to decision)
Product code
PLW Acetabular Cup Orientation System
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Materialise NV Technologielaan 15, Leuven, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLW

Trailing 12 months

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

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