Cleared Traditional

K000827 - UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

K000827 is an FDA 510(k) clearance for UNICOMPARTMENTAL PATELLOFEMORAL PROSTHE..., manufactured by Walter Abendschein, M.D.. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K000827

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.

KRR Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K000827.
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
K002356 · Sulzer Orthopedics, Inc. · Oct 2000
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
K001374 · Biomet Manufacturing, Inc. · Jul 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · Biomet, Inc. · Jul 2000
PATELLOFEMORAL JOINT PROSTHESIS
K962190 · Intermedics Orthopedics · Oct 1996