Cleared Traditional

K210695 - CPM Medical Consultants Tibial Revision...

K210695 is an FDA 510(k) clearance for CPM Medical Consultants Tibial Revision..., manufactured by Cpm Medical Consultants, LLC. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K210695 · Cpm Medical Consultants, LLC · Orthopedic device
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Aug 2021
Decision
161d
Days
Class 2
Risk

K210695 is an FDA 510(k) clearance for the CPM Medical Consultants Tibial Revision Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Cpm Medical Consultants, LLC (Richardson, US). The FDA issued a Cleared decision on August 16, 2021 after a review of 161 days - an extended review cycle.

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 Cpm Medical Consultants, LLC devices

FDA 510(k) Submission Details - K210695

510(k) Number K210695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2021
Decision Date August 16, 2021
Days to Decision 161 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
39d slower than avg
Panel avg: 122d · This submission: 161d
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 813
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K210695.
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
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K211609 · Depuy Ireland UC · Aug 2021
Journey II Mid-Level Tibial Inserts
K211671 · Smith & Nephew, Inc. · Aug 2021
GMK Sphere Revision
K211664 · Medacta International S.A. · Jul 2021
Klassic Knee System
K211602 · Total Joint Orthopedics, Inc. · Jul 2021
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K211938 · Limacorporate · Jul 2021