Cleared Special

K181280 - Patello-Femoral Wave (Kahuna) Arthroplasty System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181280 · Arthrosurface, Inc. · Orthopedic device
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Jun 2018
Decision
30d
Days
Class 2
Risk

K181280 is an FDA 510(k) clearance for the Patello-Femoral Wave (Kahuna) Arthroplasty System. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrosurface, Inc. devices

Submission Details

510(k) Number K181280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2018
Decision Date June 14, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 26
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K181280.
Overture Orthopaedics Patellofemoral System
K231253 · Overture Resurfacing, Inc. · Jul 2023
Episealer Patellofemoral System
K221048 · Episurf Medical, Inc. · Dec 2022
Avon Patello-femoral Joint Prosthesis
K211303 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jun 2021
MOTO PFJ System
K200122 · Medacta International S.A. · Apr 2020