HSHClass IIImplant
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
Orthopedic · 21 CFR 888.3590
MDR events8,110All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances5All time
Recent MDR events
8,110 adverse event reports on file
- GOLD TRIAL PIECEAug 17, 2022MalfunctionZimmer, Inc.MW5111549
- IFORMANov 2, 2018InjuryConformis, Inc.3004153240-2018-00243
- COLLECT.NO.QAS KNEE IMPLANTS VEGAJan 5, 2018MalfunctionAesculap Implant Systems9610612-2018-00005
- COLLECT.NO.QAS KNEE IMPLANTS VEGAJan 5, 2018MalfunctionAesculap Implant Systems9610612-2018-00006
- NATURAL KNEE ARTICULAR SURFACEApr 6, 2017InjuryZimmer, Inc.0001822565-2017-02114
- UNKNOWN SCORPIO PS INSERT SIZE 7 8MMFeb 3, 2017InjuryStryker Orthopaedics-mahwah0002249697-2017-00460
- UNKNOWN DEPUY LCS CLASSIC TIBIAL TRAYJan 3, 2017InjuryDepuy Orthopaedics, Inc. 18189101818910-2017-10085
- UNKNOWN DEPUY SZ 3 MBT TIBIAL TRAYNov 23, 2015InjuryDepuy Orthopaedics, Inc.1818910-2015-35729
- UNKNOWN DEPUY 3 MBT TRAYNov 23, 2015InjuryDepuy Orthopaedics, Inc.1818910-2015-35760
- UNKNOWN DEPUY SZ 2X12.5 TIBIAL INSERTNov 16, 2015InjuryDepuy Orthopaedics, Inc.1818910-2015-35091
Event type breakdown
Injury6,535
Malfunction1,076
Other439
Unspecified53
Death7
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Advanced Bio-Surfaces, Inc.Jan 28, 2008
K073233 · ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
- Advanced Bio-Surfaces, Inc.Feb 6, 2006
K053094 · ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
- Imaging Therapeutics, Inc.Dec 31, 2003
K033242 · KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
- Osteoimplant Technology, Inc.Nov 20, 2002
K022779 · OTI UNICONDULAR INTERPOSITIONAL SPACER
- Sulzer Orthopedics, Inc.Jan 4, 2001
K003269 · UNICONDYLAR INTERPOSITIONAL SPACER