Product code KRO— Orthopedic
AVL HINGE KNEE SYSTEM
- Classification name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Total cleared
- 87
- First cleared
- Most recent
Market context for product code KRO
FDA has cleared devices under product code KRO between 1979 and 2026, filed by 40 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
Top applicants under product code KRO
Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KRO
- K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
- K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more
- K252303 — Stem Extension Line (USTAR II System)
- K251665 — Triathlon® Hinge Knee System
- K242871 — ATTUNE Revision Hinge Knee
- K240043 — EVOLUTION® Hinge Knee System +13 more
- K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
- K230563 — EVOLUTION® Hinge Knee System
- K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
- K223069 — Modular Rotating Hinge Knee Systems and Compatible Components
- K223528 — Triathlon® Hinge Knee System
- K220628 — LINK Endo-Model EVO Knee System
- K211677 — ELEOS Limb Salvage System
- K211768 — LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
- K210010 — GMK Revision & Hinge Extension - TiNbN Coating
- K192798 — Zimmer Segmental System
- K190181 — Instruments for LINK MEGASYSTEM-C Family
- K191779 — Attune Revision LPS Inserts
- K190100 — USTAR II System
- K172347 — GMK Hinge, GMK Revision
- K163311 — GMK Revision Femoral Distal Augmentation
- K161520 — ELEOS Limb Salvage System
- K152431 — LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
- K151008 — LINK® MEGASYSTEM-C®
- K151118 — Smith and Nephew Legion Hinge Knee System
- K140900 — PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
- K150028 — Zimmer Segmental System XT Components
- K143179 — The LINK® Endo-Model® Knee System
- K140898 — PATIENT SPECIFIC DISTAL FEMORAL
- K140509 — BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
- K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
- K131393 — MAK OSS FEMORAL KNEE COMPONENTS
- K130299 — GMK HINGE
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
- K121029 — METS MODULAR DISTAL FEMUR
- K120992 — METS SMILES TOTAL KNEE REPLACEMENT
- K110940 — ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
- K092138 — JTS EXTENDEABLE IMPLANT
- K101815 — ENDURO KNEE SYSTEM
- K091453 — LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
- K083779 — MAK OSS KNEE FEMORAL COMPONENTS
- K083827 — ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
- K081111 — LEGION HINGE KNEE SYSTEM
- K080330 — SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
- K072367 — REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
- K070978 — ZIMMER SEGMENTAL SYSTEM
- K062301 — DEPUY LPS PROXIMAL TIBIAL COMPONENT
- K060360 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
- K060131 — OSS-BODIES PROXIMAL TIBIAL SLEEVE
- K052685 — ORTHOPEDIC SALVAGE SYSTEM- OSS
- K051479 — RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
- K051570 — AVL HINGE KNEE SYSTEM
- K041352 — COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
- K040749 — MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
- K031804 — COMPRESS DISTAL FEMORAL REPLACEMENT
- K031480 — GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
- K023667 — RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
- K023087 — GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
- K021489 — REPIPHYSIS LIMB SALVAGE SYSTEM
- K021714 — RT-PLUS PE INSERT CLAMP
- K021260 — REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
- K020381 — EXPANDABLE KNEE
- K013385 — NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
- K013340 — RT-PLUS KNEE ADDITIONAL COMPONENTS
- K013031 — MOST OPTIONS SYSTEM
- K013035 — GUARDIAN LIMB SALVAGE SYSTEM
- K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
- K003504 — RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
- K010774 — AVL HINGE KNEE SYSTEM
- K002552 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
- K001957 — MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
- K001548 — MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
- K994207 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
- K982160 — HINGED KNEE
- K972401 — HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
- K945028 — FINN KNEE SYSTEM
- K910877 — FINN KNEE PROSTHESIS
- K910596 — DCW MODULAR DISTAL FEMORAL SYSTEM
- K896048 — S-ROM/NOILES MARK 3
- K823420 — KINEMATIC II KNEE SYSTEM
- K823115 — NATURALYTE BICARBONATE DIALYSATE 4400
- K821476 — BARD ENDO LINK INTRACONDYLAR ROTATING
- K821340 — VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
- K820995 — MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
- K811105 — SEMI-CONSTRAINT KEE JOINT HINGE PROSTH
- K810520 — INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
- K781971 — KNEE SYSTEM, QUADRAXIAL CONSTRAINED
Data sourced from openFDA. This site is unofficial and independent of the FDA.