Panels › Orthopedic › Product code HRY · Class 2
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Regulation 888.3530
0510(k)s in 12 months (91 all time)
0recalls in 12 months (68 all time)
68recalls that name a 510(k)
Top companies in HRY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2024 | MicroPort Orthopedics Inc. EVOLUTION MP Femoral CS/CR Non-Porous
Non-porous MicroPort total knee replacement implants are for cemented use only. Open, Classified |
HRY | K093552 K102380 |
| Jan 26, 2023 | Biomet, Inc. Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component
Item Number: 154341 Open, Classified |
HRY | K133940 |
| Nov 22, 2022 | MicroPort Orthopedics Inc. EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base Terminated |
HRY | K093552 K102380 |
| Nov 22, 2022 | MicroPort Orthopedics Inc. EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base Terminated |
HRY | K093552 K102380 |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX.
NOTE: Information reflects Exactech recall e Open, Classified |
HRY | K040889 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System Tray Sysem knee implant devices as follows:
Tray Number/Set Name/Set Number
NM1090R Navigation Set ST0560;
NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM;
NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM;
NO182Z AS UNIVATION XF FEMUR CEMENTED Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM;
NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM;
NO158Z AS UNIVATION XF TIBIA CEMENTED Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM;
NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM;
NL496 UNIVATION F MENISCAL COMP.T3 Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM;
NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM;
NL490 UNIVATION F MENISCAL COMP.T3 R Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM;
NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM;
NL484 UNIVATION F MENISCAL COMP.T3 RM/ Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM;
NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM;
NL478 UNIVATION F MENISCAL COMP.T3 RM/ Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;
NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM;
NL472 UNIVATION F MENISCAL COMP.T3 RM Terminated |
HRY | K081293 K131167 |
| Dec 17, 2020 | Biomet, Inc. Oxford Fixed Lateral, Item numbers 154330, 154370, 154373
154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement. Terminated |
HRY | K133940 |
| Apr 17, 2020 | Biomet, Inc. Knee Products:
US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8
US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Terminated |
HRY | K042093 |
| Apr 17, 2020 | Biomet, Inc. Knee Products:
154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3
154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4
154339 Oxford Terminated |
HRY | K133940 |
| Mar 20, 2018 | DePuy Orthopaedics, Inc. (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; Terminated |
HRY | K061648 |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Sports Med
Repicci II Tibial Components
Product Usage:
Partial knee replacement Terminated |
HRY | K971938 K980665 |
| Jan 6, 2017 | Zimmer Biomet, Inc. Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum seale Terminated |
HRY | K133940 |
| Jun 15, 2015 | Biomet, Inc. Vanguard M Unicondylar Tibial Trial
For use during knee joint replacement. Terminated |
HRY | K042093 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II Unicompartmental Knee System:
UNI ALL-POLY TIB SZ 1-7mm
UNI ALL-POLY TIB SZ 1-9mm Terminated |
HRY | K033810 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II - Unicompartmental Knee Prosthesis:
CONG TIB INS SZ1/2 9MM UN
CONG TIB INS SZ1/2 11MM U
CONG TIB INS SZ1/2 13MM U
CONG TIB INS SZ3/4 9MM UN
CONG TIB INS SZ3/4 11MM U
CONG TIB INS SZ3/4 Terminated |
HRY | K955778 |
| Jan 3, 2014 | Materialise USA LLC REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE
SIGNATURE
M PKA GDE/MDL SET SML-MP
DD.....R-FEB55RKA-T JA-A01 05551
PKA POST CUT SML-PKA MICROPLASTY
CUSTOM-MADE DEVICE
non-sterile
The Terminated |
HRY | K110415 |
| Jul 11, 2013 | Biomet, Inc. REF 154239 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154238 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154237 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154236 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154235Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154232 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154231Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154230 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154229 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154228 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154225Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154224 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154223 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154222 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154221 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154218 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154217 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154216 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154215 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154214 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154211 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154210 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size 6ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee r Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154209 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154208 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154207 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154204 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
| Jul 11, 2013 | Biomet, Inc. REF 154203 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | K122277 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.