Cleared Traditional

MOORE HIP PROSTHESIS, PMMA COATED (K811416) - FDA 510(k) Clearance

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

K811416 · Zimmer, Inc. · Orthopedic device
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Aug 1981
Decision
85d
Days
Class 2
Risk

K811416 is an FDA 510(k) clearance for the MOORE HIP PROSTHESIS, PMMA COATED. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Zimmer, Inc. devices

Submission Details

510(k) Number K811416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1981
Decision Date August 12, 1981
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 49
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K811416.
MODIFIED HPS HIP PROSTHESIS
K833599 · Depuy, Inc. · Mar 1984
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · Howmedica Corp. · Mar 1983
METAL KNEE & HIP PROSTHESIS
K823051 · Zimmer, Inc. · Dec 1982
COLLARLESS TAPERED STEM HIP PROSTH. DEV
K811738 · Biomet, Inc. · Jul 1981
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K803191 · Osteonics Corp. · Jan 1981
UHR UNIVERSAL6HIP REPLACEMENT
K800207 · Osteonics Corp. · Feb 1980