510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163593Substantially Equivalent

Additive Orthopaedics Bunion System

Additive Orthopaedics, LLC, Little Silver NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163593 is the FDA 510(k) clearance record for Additive Orthopaedics Bunion System, a class II device, cleared for Additive Orthopaedics, LLC on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 7 510(k) clearances for Additive Orthopaedics, LLC, from to . As of , FDA records show no recalls naming K163593.

Clearance record

Decision date
Received
(181 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Additive Orthopaedics, LLC 83 Amelia Cir., Little Silver NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRS

Trailing 12 months
57 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20264
October 20260