510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013527Substantially Equivalent

Modification to Synthes (USA) Reamer Irrigator Aspirator (Ria) System

Synthes (USA) Products LLC, Paoli PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K013527 is the FDA 510(k) clearance record for MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM, a class I device, cleared for Synthes (Usa) 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 18 recalls naming K013527.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HTO Reamer
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary
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