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

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
KROK223528
Aug 11, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Open, Classified
KROK143179
Aug 5, 2026United Orthopedic Corp.
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A P
Open, Classified
KROK190100
Jun 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2
Open, Classified
KROK242871
Jun 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Numb
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Open, Classified
KROK242871
Apr 29, 2026DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Open, Classified
KROK242871
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Open, Classified
KROK151008
Mar 10, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Open, Classified
KROK151008
Dec 9, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Open, Classified
KROK151008
May 29, 2025Onkos Surgical, Inc.
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E
Open, Classified
KROK161520
May 29, 2025Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-2015
Open, Classified
KROK161520
May 29, 2025Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-
Open, Classified
KROK161520
May 29, 2025Onkos Surgical, Inc.
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Open, Classified
KRONone listed
May 29, 2025Onkos Surgical, Inc.
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15
Open, Classified
KROK161520
May 28, 2025Onkos Surgical, Inc.
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Open, Classified
KROK161520
Feb 29, 2024United Orthopedic Corporation
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE251
Open, Classified
KROK190100
Feb 29, 2024United Orthopedic Corporation
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE2515311
Open, Classified
KROK190100
Feb 29, 2024United Orthopedic Corporation
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm,
Open, Classified
KROK190100
Jun 30, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
Open, Classified
KROK143179
Jun 30, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
Open, Classified
KROK143179
Jun 30, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Open, Classified
KROK143179
Jun 30, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Open, Classified
KROK143179
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
Open, Classified
KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
Open, Classified
KROK152431
K212742

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