Panels › Orthopedic › Product code MBH · Class 2
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation 888.3565
9510(k)s in 12 months (146 all time)
4recalls in 12 months (103 all time)
103recalls that name a 510(k)
Top companies in MBH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Jun 23, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile,
Used to complement or replace the standard instruments used during the implantation of hip, knee, t Terminated |
MBH | K123486 |
| Jun 7, 2016 | Zimmer Biomet, Inc. Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants. Terminated |
MBH | K121771 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. TM MONO TIB STR GRN SZ 5 - 00588606510
TM MONO TIB STR GRN SZ 5 12MM - 00588606512
TM MONO TIB STR GRN SZ 5 14MM - 00588606514
TM MONO TIB STR GRN SZ 5 17MM - 00588606517
TM MONO TIB STR GRN SZ 6 10 Terminated |
MBH | K031462 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. TM LPS TIB SZ 3 C/D, 10MM - 00588605310
TM LPS TIB SZ 3 C/D, 12MM - 00588605312
TM LPS TIB SZ 3 C/D, 14MM - 00588605314
TM LPS TIB SZ 3 C/D, 17MM - 00588605317
TM LPS TIB SZ 4 C/D, 10MM - 00588605 Terminated |
MBH | K031462 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. TM CR TIB SZ 3 C-H, 10MM- 00588604310
TM CR TIB SZ 3 C-H, 12 mm - 00588604312
TM CR TIB SZ 3 C-H, 14MM - 00588604314
TM CR TIB SZ 3 C-H, 17MM - 00588604317
TM CR TIB SZ 4 C-H 10 MM - 00588604410
Terminated |
MBH | K031462 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. POROUS PATELLA 32MM X 10MM - 00587806532
POROUS PATELLA 35MM X 10MM- 00587806535
POROUS PATELLA 38MM X 10MM - 00587806538
POROUS PATELLA 41MM X 10MM - 00587806541 Terminated |
MBH | K031462 |
| Mar 25, 2016 | Biomet, Inc. Vanguard XP Knee System Porous Femoral Component
various sizes and orientation a total knee replacement system.
prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous,
coated, Terminated |
MBH | K141407 |
| Feb 22, 2016 | Zimmer Biomet, Inc. CR Flex GSF Porous Femoral
LPS Flex GSF Porous Femoral
LPS Flex Porous Femoral
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
various sizes Terminated |
MBH | K072619 |
| Aug 14, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR
REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism. Terminated |
MBH | K141056 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV FB CR TB TRL SZ3 - 10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV FB CR ARTICULATION SURFACE SZ1
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV RP PS TB TRL SZ10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacemen Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total kne Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | K140881 |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | K140881 |
| Mar 26, 2015 | Zimmer Trabecular Metal Technology, Inc. NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only.
Product Usage:
Intended for use where severe degeneration, trauma, or other pathology of the knee j Terminated |
MBH | K040487 |
| Mar 16, 2015 | Stryker Howmedica Osteonics Corp. Triathlon Distal Capture Assembly
Catalog No: 6541-1-723
The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resect Terminated |
MBH | K123486 |
| Mar 12, 2015 | Zimmer, Inc. Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
For use in either posterior crucia Terminated |
MBH | K121771 |
| Apr 12, 2013 | Stryker Howmedica Osteonics Corp. ShapeMatch Cutting Guides
Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty co Terminated |
MBH | K110533 K122053 |
| Feb 15, 2013 | DePuy Orthopaedics, Inc. LPS Diaphyseal Sleeves
Product Usage:
The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bo Terminated |
MBH | K071417 |
| Feb 15, 2013 | DePuy Orthopaedics, Inc. LPS Diaphyseal Sleeves
Product Usage:
The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bo Terminated |
MBH | K071417 |
| Feb 15, 2013 | DePuy Orthopaedics, Inc. LPS Diaphyseal Sleeves
Product Usage:
The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bo Terminated |
MBH | K071417 |
| Feb 15, 2013 | DePuy Orthopaedics, Inc. LPS Diaphyseal Sleeves
Product Usage:
The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bo Terminated |
MBH | K071417 |
| Jul 27, 2012 | Zimmer Inc. Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana
The instrument is attached to the femora Terminated |
MBH | K031061 |
| Jul 27, 2012 | Zimmer Inc. Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile
Zimmer, Warsaw Indiana
The instrument is attached to the femoral implant or provisional to Terminated |
MBH | K031061 |
| May 10, 2011 | Zimmer Inc. NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR , NONSTERILE, REF 00-5901-026-40, Zimmer UK, Ltd., Zimmer Warsaw, IN.
Intended use: The Terminated |
MBH | K031061 |
| May 10, 2011 | Zimmer Inc. NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN.
Intended use: The instrument is attached to the femoral Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA OSTEOTOMY GUIDE, REF 00-5903-010-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA CLAMP, REF 00-5903-020-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to the femora Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION FEMORAL VALGUS ALIGNMENT GUIDE, REF 00-5901-067-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attac Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL RESECTION GUIDE, REF 00-5901-063-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attac Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY MODULAR SPIKE ARM POST, REF 00-5901-074-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument i Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY PROXIMAL TELESCOPING ROD, REF 00-5901-072-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY DISTAL
TELESCOPING TUBE, REF 00-5901-071-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION MODULAR T-HANDLE, REF 00-5901-061-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to the fem Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION QUICK-CONNECT HANDLE, REF 00-5901-034-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to the Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA PEG DRILL GUIDE HANDLE, REF 00-5903-060-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attac Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER Boom, REF 00-5901-040-10, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is att Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER, REF 00-5901-040-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached Terminated |
MBH | K031061 |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION, FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, REF 00-5901-026-00, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is atta Terminated |
MBH | K031061 |
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