FDA.reportPublic FDA data

MAXX ORTHOPEDICS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073118783007311878MAXX ORTHOPEDICS INC.1N2026-01-012460 General Armistead Ave Suite 100 Norristown PA US 19403

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
999561907520723K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO2026-01-15
999561032965555K253144Freedom® Total Knee System – Titan PCK ComponentsJWH2025-10-22
999561281039107K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH2025-10-31
999561430872797K251717Freedom® Total Knee System – Titanium Tibial Base PlateJWH2025-06-26
999561277837874K250382Freedom Total Knee System (All-poly Tibial Plate)JWH2025-03-13
999561416682296K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY2025-08-25
999561952947452K243277Freedom® Medial Congruent LinerJWH2024-11-19
999561023051659K241597Freedom® Total Knee System - Porous Tibial Base PlateMBH2025-02-13
999561172226383K240863Freedom® Total Knee SystemJWH2024-07-02
999561337854113K212870TLC Unicompartmental Knee SystemHSX2022-06-16
999561825663806K200912Freedom(R) - TiNbN Coated KneeJWH2020-11-18
999561032144581K192989Libertas E-XLPE Modular LinerOQI2020-10-29
999562050752327K192148Freedom Primary PCKJWH2019-09-05
999561818459898K183684Libertas – Taper Uncemented Femoral StemLZO2019-08-23
999561610193931K183365Libertas Acetabular Hooded LinerLZO2019-02-22
999561915811749K182574Freedom Ultra-Congruent CR Tibial LinerJWH2019-01-22
999561765670559K180973Libertas Hip Replacement SystemJDI2018-09-28
999561158210043K16308140-42mm BiPolar Head and 22mm Femoral HeadKWY2018-01-29
999561428142622K150680Freedom Cementless Femoral ComponentMBH2015-06-26
999561740796243K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CELPH2014-07-22
999561990069878K131481FREEDOM PCK COMPONENTSJWH2014-02-21
999562004325201K111785FREEDOM(R) STEMMED TIBIAL COMPONENTSJWH2012-06-29
999561778970320K091280FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENTJWH2009-09-25
999561015455182K090411FREEDOM METAL BACKED TIBIAL COMPONENTJWH2009-04-07
999561422224168K082019FREEDOM TOTAL KNEE SYSTEMJWH2009-02-06
999561571941795K072704UNICOMPARTMENTAL KNEEHRY2008-02-19
999561030995176
999561105507578
999561573047935
999561663940798
999561761399113
999561836317575
999561869882910
999562057418839
999561010197356
999561022010374
999561127942191
999561174817195
999561181068712
999561252035698
999561379468965
999561391280753
999561426034869
999561498425221
999561852176665

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH202025-10-22
LZO52026-01-15
MBH42025-10-31
KWY22025-08-25
JDI22018-09-28
HRY22008-02-19
HSX12022-06-16
OQI12020-10-29
LPH12014-07-22

PMN#