510(k) clearances

Freedom Partial Knee System

Maxx Orthopedics, Inc. · Orthopedic

K261609Substantially EquivalentTraditionalHSX
Open FDA's page for this record
Third party flag
N
City
Norristown
Advisory committee description
Orthopedic
Address 1
2460 General Armistead Ave. #100
Statement or summary
Summary
Product code
HSX
Zip code
19403
Applicant
Maxx Orthopedics, Inc.
Decision date
2026-08-04
Decision code
SESE
Country code
US
Device name
Freedom Partial Knee System
Advisory committee
OR
Contact
Asawari Hare
K number
K261609
State
PA
Date received
2026-05-14
Review advisory committee
OR
Postal code
19403
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Medical specialty description
Orthopedic
Regulation number
888.3520
Device class
2
Registration number
2249615, 3007311878, 3013176080, 3017410889, 3000264985, 3001239363, 3010097171, 3020155054, 1834331, 3010220595, 1223434, 3007539489, 3005061536, 3012523063, 3009241418, 3016851379, 9616680, 3009555447, 1833920, 3010287685, 3008110533, 1048735, 3003639920, 1450662, 2133928, 3016438694, 1722511, 3002808022, 1825034, 9614209, 9610726, 3009887475, 3006783837, 1000517406, 9681465, 1828464, 3012319330, 3015207155, 3009555440, 1424263 +118 more
FEI number
1000118610, 3007311878, 3013176080, 3000264985, 3001239363, 3010097171, 3020155054, 3010220595, 3002807172, 3007539489, 3005061536, 3003292403, 3012523063, 3009241418, 3016851379, 3002459190, 3009555447, 3002807113, 1000120613, 3010287685, 3008110533, 1048735, 3003639920, 1450662, 1000221916, 3002287318, 3016438694, 3002808022, 1825034, 3005985723, 3009887475, 3003110073, 1000517406, 1000115656, 1828464, 3012319330, 3015207155, 3009555440, 3035366890, 1219602 +118 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.