Cleared Traditional

K900051 - MOORE TYPE ENDO PROSTHESIS

K900051 is an FDA 510(k) clearance for MOORE TYPE ENDO PROSTHESIS, manufactured by Lima Intl. Corp.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K900051 · Lima Intl. Corp. · Orthopedic device
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Oct 1990
Decision
273d
Days
Class 2
Risk

K900051 is an FDA 510(k) clearance for the MOORE TYPE ENDO PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Lima Intl. Corp. (E Providence, US). The FDA issued a Cleared decision on October 3, 1990 after a review of 273 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 Lima Intl. Corp. devices

FDA 510(k) Submission Details - K900051

510(k) Number K900051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1990
Decision Date October 03, 1990
Days to Decision 273 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 122d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 96
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K900051.
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM
K913632 · Kirschner Medical Corp. · Nov 1991
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · Exactech, Inc. · Feb 1991
ACUFIT TOTAL HIP
K904383 · Acu Med, Inc. · Dec 1990
LEINBACH HIP PROSTHESIS
K896257 · 3M Company · Jan 1990
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · 3M Company · Jan 1990
VS22 HIP PROSTHESIS
K896266 · 3M Company · Nov 1989