FDA 510(k)

PNK Total Knee System

K-Number: K231975 · 2023-11-21

Decision Date2023-11-21

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PNK Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Tjc Life Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K231975. 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 PNK Total Knee System?

PNK Total Knee System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Tjc Life Co., Ltd.. The 510(k) number is K231975.

When did PNK Total Knee System receive FDA 510(k) clearance?

PNK Total Knee System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K231975.

Who is the listed applicant for PNK Total Knee System?

The FDA 510(k) record lists Tjc Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNK Total Knee System?

The FDA product code for PNK Total Knee System is JWH.

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 UC K261032NovoKnee (SteriKnee)NovoSource K253793Materialise TKA Guide SystemMaterialise NV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.