510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223421Substantially Equivalent

MedCAD AccuPlan Orthopedics System

MedCAD, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223421 is the FDA 510(k) clearance record for MedCAD AccuPlan Orthopedics System, a class II device, cleared for Medcad 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 9 510(k) clearances for Medcad, from to . As of , FDA records show no recalls naming K223421.

Clearance record

Decision date
Received
(314 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
Medcad 501 S 2nd Ave., Dallas TX
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