ClearanceBrief
Panels › Orthopedic › Product code KRO · Class 2

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Regulation 888.3510

2510(k)s in 12 months (87 all time)
28recalls in 12 months (124 all time)
121recalls that name a 510(k)
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Top companies in KRO

Company510(k)sRecalls
Biomet, Inc.912
Waldemar Link GmbH & Co. KG (Mfg Site)019
LinkBio Corp.116
Zimmer Biomet, Inc.016
Depuy(Ireland)111
Stanmore Implants Worldwide , Ltd.57
Zimmer, Inc.66
Onkos Surgical29
DePuy Orthopaedics, Inc.28
Howmedica Osteonics Corp.91
DateFirm and productCodeLinked 510(k)
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
Open, Classified		 KROK152431
K212742
Mar 17, 2023DePuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Open, Classified		 KROK191779
Mar 17, 2023DePuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Open, Classified		 KROK191779
Mar 17, 2023DePuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Open, Classified		 KROK191779
Mar 17, 2023DePuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Open, Classified		 KROK191779
Aug 27, 2021Uoc Usa Inc
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Terminated		 KROK190100
Oct 10, 2018Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Terminated		 KROK002757
Feb 1, 2018Smith & Nephew, Inc.
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arth
Terminated		 KROK081111
Aug 1, 2017Zimmer Biomet, Inc.
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item
Terminated		 KROK070978
Jul 4, 2017Stanmore Implants Worldwide Ltd.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Terminated		 KROK092138
K133152 +1
Jun 12, 2017Medacta Usa Inc
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Terminated		 KROK130299
Jun 5, 2017Zimmer Biomet, Inc.
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Terminated		 KROK020381
Jun 5, 2017Zimmer Biomet, Inc.
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
Terminated		 KROK020381
May 23, 2017Onkos Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
Terminated		 KROK161520
May 23, 2017Onkos Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Terminated		 KROK161520
May 23, 2017Onkos Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Terminated		 KROK161520
Apr 25, 2017Zimmer Biomet, Inc.
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Terminated		 KRONone listed
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 KROK070978
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 18x250mm bwd, Sterile,
Terminated		 KROK070978
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated		 KROK965098
Mar 20, 2017Zimmer Biomet, Inc.
Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 KROK070978
Jan 28, 2017Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Terminated		 KROK083827
Dec 19, 2016Stanmore Implants Worldwide Ltd.
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a com
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The p
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, di
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the
Terminated		 KROK120992
Aug 17, 2016Stanmore Implants Worldwide Ltd.
METS SMILES Total Knee Replacement
Terminated		 KROK120992
May 26, 2016Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, o
Terminated		 KROK081111
May 26, 2016Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or
Terminated		 KROK081111
May 26, 2016Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis,
Terminated		 KROK081111
May 26, 2016Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis,
Terminated		 KROK081111
May 26, 2016Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis,
Terminated		 KROK081111
May 26, 2016Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis,
Terminated		 KROK081111
Nov 14, 2015Medacta Usa
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Terminated		 KROK130299
Mar 20, 2014Zimmer, Inc.
MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM
Terminated		 KROK013031
Mar 13, 2014DePuy Orthopaedics, Inc.
REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there i
Terminated		 KROK896048
Mar 13, 2014DePuy Orthopaedics, Inc.
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there i
Terminated		 KROK896048

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