Cleared Traditional

K000827 - UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED (FDA 510(k) Clearance)

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

K000827 · Walter Abendschein, M.D. · Orthopedic device
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Jun 2000
Decision
101d
Days
Class 2
Risk

K000827 is an FDA 510(k) clearance for the UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Walter Abendschein, M.D. (Chevy Chase, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 101 days - within the typical 510(k) review window.

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 Walter Abendschein, M.D. devices

Submission Details

510(k) Number K000827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date June 23, 2000
Days to Decision 101 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
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 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 K000827.
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