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FDA 510(k)

ATTUNE All-Polyethylene Tibia

K-Number: K193057 · 2020-01-30

ApplicantDepuy Ireland UC
Decision Date2020-01-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE All-Polyethylene Tibia is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2020-01-30 under approval number K193057. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTUNE All-Polyethylene Tibia?

ATTUNE All-Polyethylene Tibia is a medical device that received FDA 510(k) clearance on 2020-01-30. It is manufactured by Depuy Ireland UC. The 510(k) number is K193057.

When was ATTUNE All-Polyethylene Tibia approved by the FDA?

ATTUNE All-Polyethylene Tibia received FDA 510(k) clearance on 2020-01-30, under approval number K193057.

What company makes ATTUNE All-Polyethylene Tibia?

ATTUNE All-Polyethylene Tibia is manufactured by Depuy Ireland UC.

What is the FDA product code for ATTUNE All-Polyethylene Tibia?

The FDA product code for ATTUNE All-Polyethylene Tibia is JWH.

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025)

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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.

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