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FDA 510(k)

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

K-Number: K232414 · 2023-09-08

ApplicantTotal Joint Othopedics, Inc.
Decision Date2023-09-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K232414. 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 Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K232414.

When did Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post receive FDA 510(k) clearance?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post received FDA 510(k) clearance on 2023-09-08, under 510(k) number K232414.

Who is the listed applicant for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

The FDA 510(k) record lists Total Joint Othopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

The FDA product code for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is JWH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07544264Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial ComponentRECRUITING

Other records listing Total Joint Othopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243991Klassic Knee System - Revision Tibial BaseplateK230537Klassic Knee Revision SystemK213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthK191399BIOLOX CONTOURA Ceramic Femoral HeadK171962Klassic HD® Hip SystemK161073Klassic HD Hip System

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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