Cleared Traditional

KeYi Total Knee System (K230120) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230120 · Beijing Keyi Medical Device Technology Co., Ltd. · Orthopedic device
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Apr 2024
Decision
458d
Days
Class 2
Risk

K230120 is an FDA 510(k) clearance for the KeYi Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Beijing Keyi Medical Device Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 19, 2024 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Beijing Keyi Medical Device Technology Co., Ltd. devices

Submission Details

510(k) Number K230120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date April 19, 2024
Days to Decision 458 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
336d slower than avg
Panel avg: 122d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 542
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K230120.
Unity Knee PS-C Tibial Insert
K240875 · Corin U.S.A. Limited · Jun 2024
ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
K240669 · Globus Medical, Inc. · Jun 2024
EMPOWR Revision Symmetric Knee Cones
K240324 · Encore Medical, L.P Dba Enovis · 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
PNK Total Knee System
K231975 · Tjc Life Co., Ltd. · Nov 2023