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)
Top companies in KRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica 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 |
KRO | K223528 |
| Aug 11, 2026 | Waldemar 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 |
KRO | K143179 |
| Aug 5, 2026 | United 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 |
KRO | K190100 |
| Jun 29, 2026 | DEPUY (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 |
KRO | K242871 |
| Jun 29, 2026 | DEPUY (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 |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. Open, Classified |
KRO | K242871 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/16; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/12; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/11; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/15; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/11; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8521/09; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-8030/12; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-2836/11; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-2835/12; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model SL Connection Component incl. PE-Plateau;
Item Number: 16-2840/07; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model SL Connection Component incl. PE-Plateau;
Item Number: 16-2840/02; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model Replacement Plateau;
Item Number: 15-0027/15; Open, Classified |
KRO | K151008 |
| Mar 10, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo-Model SL Connection Component incl. PE-Plateau;
Item Number: 16-2840/05; Open, Classified |
KRO | K151008 |
| Dec 9, 2025 | Waldemar 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 |
KRO | K151008 |
| May 29, 2025 | Onkos 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 |
KRO | K161520 |
| May 29, 2025 | Onkos 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 |
KRO | K161520 |
| May 29, 2025 | Onkos 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 |
KRO | K161520 |
| May 29, 2025 | Onkos 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 |
KRO | None listed |
| May 29, 2025 | Onkos 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 |
KRO | K161520 |
| May 28, 2025 | Onkos Surgical, Inc. ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E.
Component of ELEOS Limb Salvage System Open, Classified |
KRO | K161520 |
| Feb 29, 2024 | United 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 |
KRO | K190100 |
| Feb 29, 2024 | United 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 |
KRO | K190100 |
| Feb 29, 2024 | United 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 |
KRO | K190100 |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left Open, Classified |
KRO | K143179 |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right Open, Classified |
KRO | K143179 |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left Open, Classified |
KRO | K143179 |
| Jun 30, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right Open, Classified |
KRO | K143179 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2230/15 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2230/14 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2230/13 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2230/12 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2230/11 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2230/10 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2230/08 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2230/07 Open, Classified |
KRO | K152431 K212742 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2230/06 Open, Classified |
KRO | K152431 K212742 |
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