510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K163156Substantially Equivalent

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

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

K163156 is the FDA 510(k) clearance record for SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, a class II device, cleared for Materialise NV on under FDA product code PBF (Orthopaedic Surgical Planning And Instrument Guides). FDA's definition for product code PBF reads: "As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures". FDA records list 61 510(k) clearances for Materialise NV, from to . As of , FDA records show no recalls naming K163156.

Clearance record

Decision date
Received
(69 days to decision)
Product code
PBF Orthopaedic Surgical Planning And Instrument Guides
Regulation
21 CFR 888.3030
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 PBF

Trailing 12 months
4 clearances under product code PBF in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code PBF, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260