Cleared Traditional

K221048 - Episealer Patellofemoral System (FDA 510(k) Clearance)

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

K221048 · Episurf Medical, Inc. · Orthopedic device
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Dec 2022
Decision
259d
Days
Class 2
Risk

K221048 is an FDA 510(k) clearance for the Episealer Patellofemoral System. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Episurf Medical, Inc. (New York, US). The FDA issued a Cleared decision on December 23, 2022 after a review of 259 days - an extended review 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: 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 Episurf Medical, Inc. devices

Submission Details

510(k) Number K221048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2022
Decision Date December 23, 2022
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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

Mcra, LLC
Hollace Saas Rhodes

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