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510(k) K111437

SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) by Synthes (USA) Products, LLC — Product Code HTO

K111437 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)". The FDA issued a decision of Substantially Equivalent on August 10, 2011. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2011
Date Received
May 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (September 18, 2020)
  • K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (September 10, 2020)
  • K201578 — DePuy Synthes Variable Angle Locking Patella Plating System (September 9, 2020)
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Other clearances for product code HTO

  • K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (March 16, 2005)
  • K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (December 21, 2001)
  • K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (June 12, 2000)
  • K954915 — FLEXIBLE INTRAMEDULLARY REAMER (December 28, 1995)
  • K903248 — COMBINATION REAMER (July 30, 1990)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K870845 — WARSAW ORTHOPEDIC POINTED REAMER (March 11, 1987)
  • K862933 — ABC-1000 SMALL JOINT REAMERS (August 18, 1986)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K811081 — MEDULLARY CANAL SCRAPERS (April 29, 1981)

FDA data resources