Cleared Traditional

K173970 - Materialise PKA Guide System

K173970 is an FDA 510(k) clearance for Materialise PKA Guide System, manufactured by Materialise NV. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K173970 · Materialise NV · Orthopedic device
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Jul 2018
Decision
189d
Days
Class 2
Risk

K173970 is an FDA 510(k) clearance for the Materialise PKA Guide System. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on July 6, 2018 after a review of 189 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 Materialise NV devices

FDA 510(k) Submission Details - K173970

510(k) Number K173970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2017
Decision Date July 06, 2018
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 111
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K173970.
Journey II Unicompartmental Knee System
K190085 · Smith & Nephew, Inc. · Feb 2019
MOTO Partial Knee System
K183029 · Medacta International S.A. · Jan 2019
Bodycad Unicompartmental Knee System
K181302 · Bodycad Laboratories, Inc. · Jan 2019
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
K180612 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Jun 2018
Materialise PKA Guide System
K172650 · Materialise NV · Nov 2017
Tahoe Uni Knee System
K170344 · Consensus Orthopedics, Inc. · Oct 2017