Cleared Traditional

Knee+ (K220104) - FDA 510(k) Clearance

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

K220104 · Pixee Medical · Orthopedic device
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Sep 2022
Decision
232d
Days
Class 2
Risk

K220104 is an FDA 510(k) clearance for the Knee+. Classified as Orthopedic Augmented Reality (product code SBF), Class II - Special Controls.

Submitted by Pixee Medical (Besançon, FR). The FDA issued a Cleared decision on September 1, 2022 after a review of 232 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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.

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Submission Details

510(k) Number K220104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2022
Decision Date September 01, 2022
Days to Decision 232 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
110d slower than avg
Panel avg: 122d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SBF Orthopedic Augmented Reality
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As “augmented Reality” Stereoscopic Images To Intraoperatively Augment The User’s Field Of View.
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 - SBF Orthopedic Augmented Reality

All 41
Devices cleared under the same product code (SBF) and FDA review panel - the closest regulatory comparables to K220104.
Caduceus S
K220554 · Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Dec 2022
xvision Spine System
K220905 · Augmedics, Ltd. · Nov 2022
SpineAR SNAP
K213034 · Surgical Theater, Inc. · Sep 2022
OptiVu ROSA MxR
K220733 · Orthosoft Inc. (d/b/a) Zimmer CAS · Jul 2022
NextAR™ TKA Platform My Knee PPS
K213751 · Medacta International S.A. · Mar 2022
ARAI Surgical Navigation System
K211254 · Surgalign Spine Technologies · Jan 2022