ClearanceBrief
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)
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Top companies in MBH

Company510(k)sRecalls
Zimmer, Inc.1919
Howmedica Osteonics Corp.920
Microport Orthopedics, Inc.812
DePuy Orthopaedics, Inc.215
Smith & Nephew, Inc.124
Zimmer Biomet112
Biomet, Inc.74
Wrightmedicaltechnologyinc80
Zimmer Trabecular Metal Technology35
Biomet Manufacturing Corp60
DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified		 MBHK033972
Jun 24, 2026Zimmer, Inc.
Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Tra
Open, Classified		 MBHK181947
K191625 +1
Jun 17, 2026Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Open, Classified		 MBHK123486
Jun 17, 2026Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Open, Classified		 MBHK123486
Dec 18, 2024MicroPort Orthopedics Inc.
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
Open, Classified		 MBHK093552
K102380 +1
Apr 22, 2024Biomet, Inc.
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed
Open, Classified		 MBHK050222
Mar 29, 2024DePuy Orthopaedics, Inc.
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Open, Classified		 MBHK202194
K213781 +1
Mar 6, 2024Howmedica Osteonics Corp.
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Open, Classified		 MBHK172634
Mar 6, 2024Howmedica Osteonics Corp.
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Open, Classified		 MBHK172634
Mar 6, 2024Howmedica Osteonics Corp.
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Open, Classified		 MBHK172634
Mar 6, 2024Howmedica Osteonics Corp.
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Open, Classified		 MBHK172634
Mar 6, 2024Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 7 9 MM
Open, Classified		 MBHK172634
Mar 6, 2024Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 6 11 MM
Open, Classified		 MBHK172634
Mar 6, 2024Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 6 10 MM
Open, Classified		 MBHK173849
Mar 6, 2024Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 3 10 MM
Open, Classified		 MBHK173849
Dec 7, 2023Encore Medical, LP
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of
Open, Classified		 MBHK171991
Nov 7, 2023Encore Medical, LP
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Open, Classified		 MBHK171991
May 30, 2023Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Open, Classified		 MBHK172634
May 30, 2023Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Open, Classified		 MBHK173849
Apr 12, 2023Encore Medical, LP
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Open, Classified		 MBHK212941
Feb 10, 2021Howmedica Osteonics Corp.
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Terminated		 MBHK123486
K141056
Oct 7, 2020Encore Medical, LP
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of
Open, Classified		 MBHK171991
Sep 4, 2020Biomet, Inc.
Biomet Regenerex Primary Taper Cap Item Number 141269
Terminated		 MBHK080361
Apr 17, 2020Biomet, Inc.
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Terminated		 MBHK083782
Dec 16, 2019Smith & Nephew, Inc.
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic man
Open, Classified		 MBHK121393
Aug 19, 2019Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Ar
Terminated		 MBHK141056
K190991
Aug 19, 2019Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Prim
Terminated		 MBHK141056
K190991
Aug 19, 2019Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Ar
Terminated		 MBHK141056
K190991
Aug 19, 2019Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Art
Terminated		 MBHK141056
K190991
Sep 18, 2018Smith & Nephew, Inc.
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the d
Terminated		 MBHK121393
May 4, 2018Smith & Nephew, Inc.
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Terminated		 MBHK121393
Apr 9, 2018Smith & Nephew, Inc.
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthr
Terminated		 MBHK121393
Jan 30, 2018Howmedica Osteonics Corp.
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and r
Terminated		 MBHK141056
Jan 12, 2018Howmedica Osteonics Corp.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Terminated		 MBHK141056
Nov 29, 2017Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR
Terminated		 MBHK070214
K071107
Nov 29, 2017Zimmer Biomet, Inc.
NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibia
Terminated		 MBHK072619
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
Terminated		 MBHK023211
K031061 +1
Nov 29, 2017Zimmer Biomet, Inc.
LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients with s
Terminated		 MBHK031061
K933785
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP
Terminated		 MBHK041100
Nov 29, 2017Zimmer Biomet, Inc.
CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HAT
Terminated		 MBHK041100
Nov 29, 2017Zimmer Biomet, Inc.
CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
Terminated		 MBHK031061
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 MBHK960658
Oct 3, 2017Zimmer Biomet, Inc.
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Terminated		 MBHK113550
Apr 25, 2017Zimmer Biomet, Inc.
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any
Terminated		 MBHK083782
Sep 13, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for th
Terminated		 MBHK033972
Sep 8, 2016MicroPort Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, ST
Terminated		 MBHK061223
Sep 8, 2016MicroPort Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERI
Terminated		 MBHK061223
Sep 8, 2016MicroPort Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, ST
Terminated		 MBHK061223
Sep 8, 2016MicroPort Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERI
Terminated		 MBHK061223
Sep 8, 2016MicroPort Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, ST
Terminated		 MBHK061223

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