510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111437Substantially Equivalent

Synthes Ria System (Expanded Indications)

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111437 is the FDA 510(k) clearance record for SYNTHES RIA SYSTEM (EXPANDED INDICATIONS), a class I device, cleared for Synthes (USA) Products, LLC on under FDA product code HTO (Reamer). FDA records list 479 510(k) clearances for Synthes (USA) Products, LLC, from to . As of , FDA records show 19 recalls naming K111437.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HTO Reamer
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Synthes (USA) Products, LLC 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTO

Trailing 12 months

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

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