Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Orthopedic · 21 CFR 888.3560
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Recent MDR events
1,136 adverse event reports on file
- MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MMMay 11, 2026InjuryMako Surgical Corp.3005985723-2026-00231
- SIGMAMay 7, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-08445
- SIGMAMay 7, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-08446
- SIGMAMay 7, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-08447
- IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMMay 7, 2026InjuryRestor3d, Inc.3014833750-2026-00009
- MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MMMay 4, 2026InjuryStryker Orthopaedics-mahwah3005985723-2026-00215
- UNKNOWN STRYKER MCK 6X10 INSERTApr 24, 2026InjuryMako Surgical Corp.3005985723-2026-00192
- MCK PATELLOFEMORAL-L-SZ 2Mar 24, 2026InjuryMako Surgical Corp.3005985723-2026-00142
- MCK TIBIAL BASEPLATE-LM/RL-SZ 6Mar 24, 2026InjuryMako Surgical Corp.3005985723-2026-00139
- SIGMA HP UNI TIB TRAY SZ2 RMLLMar 6, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-04382
Event type breakdown
Recalls
8 recall events for this product code
- Mako Surgical CorporationTerminatedJun 1, 2018
Restoris MCK Onlay Insert Extractor.
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Z-2051-2018 · View FDA record ↗ - ConforMIS, Inc.TerminatedOct 21, 2015
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral
May contain small amounts of ethylene glycol residue
Z-0142-2016 · View FDA record ↗ - ConforMIS, Inc.TerminatedOct 21, 2015
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial
May contain small amounts of ethylene glycol residue
Z-0143-2016 · View FDA record ↗ - ConforMIS, Inc.TerminatedOct 21, 2015
ConFormis iDUO G2, Right Lateral
May contain small amounts of ethylene glycol residue
Z-0148-2016 · View FDA record ↗ - Mako Surgical CorporationTerminatedMar 4, 2014
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is compos
The product may be mislabeled and could result in the incorrect implant being used.
Z-1132-2014 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedJan 11, 2012
Eius Unicompartmental Knee System
Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
Z-0606-2012 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 24, 2005
The Triathlon Posteriorly Stabilized Femoral Component.
The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.
Z-0556-05 · View FDA record ↗ - Mako Surgical CorporationTerminatedUnknown
Restoris Multicompartmental Knee (MCK) System
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Z-1031-2016 · View FDA record ↗
Registered firms
150 firms currently registered for this product code
Engineered Medical Systems, Llc
Bartlett, TN, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Blue Belt Technologies, Inc.
Pittsburgh, PA, US
Paragon Medical Device (changzhou) Co., Ltd.
Changzhou Jiangsu, CN
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Almark Tool & Manufacturing Company, Inc.
Garwood, NJ, US
Medacta International Sa
Castel San Pietro Ticino, CH
Mako Surgical Corp.
Weston, FL, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
Perryman Company
Houston, PA, US
Depuy Orthopaedics, Inc.
RAYNHAM, MA, US
Lincotek Medical Llc
Vandalia, OH, US
Smith & Nephew, Inc.
Memphis, TN, US
Turner Medical Inc.
Athens, AL, US
Conformis, Inc.
Wilmington, MA, US
Huron Tool & Cutter Grinding
Farmingdale, NY, US
Autocam Medical
Murfreesboro, TN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Oberg Medical Products Company
Sarver, PA, US
Stryker Ireland Osteonics
Cork Cork (County), IE
510(k) clearances
12 clearances for this product code
- Mako Surgical Corp.Mar 10, 2015
K150307 · RESTORIS Multicompartmental Knee System
- Mako Surgical CorporationDec 10, 2013
K133039 · RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
- Conformis, Inc.Dec 16, 2009
K093513 · IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
- Smith & Nephew, Inc.Dec 15, 2009
K093056 · SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
- Mako Surgical CorporationJun 17, 2009
K090763 · RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
- DePuy Orthopaedics, Inc.Jun 26, 2007
K070849 · DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
- DePuy Orthopaedics, Inc.Sep 11, 2006
K061648 · DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
- Smith & Nephew, Inc.Jul 6, 2006
K061569 · SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS