MOTOTM Partial Knee & MOTO PFJ Systems Extension
K-Number: K213071 · 2021-11-16
ApplicantMedacta International S.A.
Decision Date2021-11-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MOTOTM Partial Knee & MOTO PFJ Systems Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-11-16 under approval number K213071. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MOTOTM Partial Knee & MOTO PFJ Systems Extension?
MOTOTM Partial Knee & MOTO PFJ Systems Extension is a medical device that received FDA 510(k) clearance on 2021-11-16. It is manufactured by Medacta International S.A.. The 510(k) number is K213071.
When was MOTOTM Partial Knee & MOTO PFJ Systems Extension approved by the FDA?
MOTOTM Partial Knee & MOTO PFJ Systems Extension received FDA 510(k) clearance on 2021-11-16, under approval number K213071.
What company makes MOTOTM Partial Knee & MOTO PFJ Systems Extension?
MOTOTM Partial Knee & MOTO PFJ Systems Extension is manufactured by Medacta International S.A..
What is the FDA product code for MOTOTM Partial Knee & MOTO PFJ Systems Extension?
The FDA product code for MOTOTM Partial Knee & MOTO PFJ Systems Extension is HSX.
Other Devices by Medacta International S.A.
Related Devices (Code: HSX)
K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc.
K161592Persona Partial Knee SystemBiomet, Inc.
K160738ZUK Select Knee SystemSmith & Nephew, Inc.
K172650Materialise PKA Guide SystemMaterialise NV
K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.
K161741GMK UNIMedacta International S.A.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.