Cleared Traditional

CORIN BIPOLAR PROSTHESIS (K925897) - FDA 510(k) Clearance

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

K925897 · Corin Orthopedic Products · Orthopedic device
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Aug 1993
Decision
263d
Days
Class 2
Risk

K925897 is an FDA 510(k) clearance for the CORIN BIPOLAR PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Corin Orthopedic Products (Washington, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 263 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 Corin Orthopedic Products devices

Submission Details

510(k) Number K925897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date August 09, 1993
Days to Decision 263 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 122d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K925897.
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · Johnson & Johnson Professionals, Inc. · Apr 1995
P.F.C. TOTAL HIP SYSTEM
K944132 · Johnson & Johnson Professionals, Inc. · Jan 1995
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · Howmedica Corp. · Mar 1994
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · Exactech, Inc. · Feb 1991
LEINBACH HIP PROSTHESIS
K896257 · 3M Company · Jan 1990
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · 3M Company · Jan 1990