Cleared Traditional

K171269 - X-PSI Knee System

K171269 is an FDA 510(k) clearance for X-PSI Knee System, manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K171269 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
241d
Days
Class 2
Risk

K171269 is an FDA 510(k) clearance for the X-PSI Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on December 28, 2017 after a review of 241 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 Orthosoft Inc. (d/b/a) Zimmer CAS devices

FDA 510(k) Submission Details - K171269

510(k) Number K171269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2017
Decision Date December 28, 2017
Days to Decision 241 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 122d · This submission: 241d
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 801
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K171269.
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
K173875 · Stelkast, Inc. · Jan 2018
Unity Total Knee System
K173884 · Corin U.S.A. Limited · Jan 2018
Smith & Nephew Patient Matched Cutting Blocks
K172336 · Smith & Nephew, Inc. · Jan 2018
JOURNEY II XR Knee Instruments
K173331 · Smith & Nephew, Inc. · Nov 2017
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
K172326 · Stryker Orthopaedics · Oct 2017
MyKnee PPS-Pin Positioners
K170106 · Medacta International S.A. · Oct 2017