ClearanceBrief
510(k) K111437 ยท HTO Reamer

SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)

ApplicantSynthes (USA) Products, LLC, West Chester PA, US
DecisionSubstantially Equivalent, Aug 10, 2011
ReceivedMay 24, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K111437

DateFirm and productCodeLinked 510(k)
Mar 1, 2024Synthes (USA) Products LLC
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullar
Open, Classified		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
Terminated		 HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
Terminated		 HTONone listed
Jul 16, 2015Synthes, Inc.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to
Terminated		 HTONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.