Cleared Traditional

Overture Orthopaedics Patellofemoral System (K231253) - FDA 510(k) Clearance

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

K231253 · Overture Resurfacing, Inc. · Orthopedic device
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Jul 2023
Decision
67d
Days
Class 2
Risk

K231253 is an FDA 510(k) clearance for the Overture Orthopaedics Patellofemoral System. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Overture Resurfacing, Inc. (New York, US). The FDA issued a Cleared decision on July 7, 2023 after a review of 67 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Overture Resurfacing, Inc. devices

Submission Details

510(k) Number K231253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date July 07, 2023
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Cor Medical Ventures, Inc.
Benjamin Arnold

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 13
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K231253.
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
Patello-Femoral Wave (Kahuna) Arthroplasty System
K181280 · Arthrosurface, Inc. · Jun 2018
Arthrex iBalance BiCompartmental Arthroplasty System
K160461 · Arthrex, Inc. · Apr 2016
Prelude PF Patellae
K143543 · Biomet, Inc. · Jan 2015