Cleared Traditional

K231975 - PNK Total Knee System

K231975 is an FDA 510(k) clearance for PNK Total Knee System, manufactured by Tjc Life Co., Ltd.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K231975 · Tjc Life Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
141d
Days
Class 2
Risk

K231975 is an FDA 510(k) clearance for the PNK Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Tjc Life Co., Ltd. (Yeongdengpo-Gu, KR). The FDA issued a Cleared decision on November 21, 2023 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tjc Life Co., Ltd. devices

FDA 510(k) Submission Details - K231975

510(k) Number K231975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date November 21, 2023
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K231975.
KeYi Total Knee System
K230120 · Beijing Keyi Medical Device Technology Co., Ltd. · Apr 2024
XN Knee Prosthesis System
K232175 · Beijing Chunlizhengda Medical Instruments Co., Ltd. · Apr 2024
AMF TT Cones
K234011 · Lima Corporate S.P.A. · Jan 2024
TRAX® CR Total Knee System
K230078 · Amplitude · Nov 2023
EVOLUTION® Cement Keel
K231947 · Microport Orthopedics, Inc. · Oct 2023
Balanced Knee® System TriMax PS Plus Tibial Insert
K233093 · Ortho Development Corporation · Oct 2023