Cleared Traditional

K925866 - CENATOR TOTAL HIP SYSTEM

K925866 is an FDA 510(k) clearance for CENATOR TOTAL HIP SYSTEM, manufactured by Corin Orthopedic Products. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K925866 · Corin Orthopedic Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
308d
Days
Class 2
Risk

K925866 is an FDA 510(k) clearance for the CENATOR TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Corin Orthopedic Products (Washington, US). The FDA issued a Cleared decision on September 23, 1993 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K925866

510(k) Number K925866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date September 23, 1993
Days to Decision 308 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
186d slower than avg
Panel avg: 122d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 524
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K925866.
HOWMEDICA REVISION HIP SYSTEM
K930460 · Howmedica Corp. · Feb 1994
PERFECTA TOTAL HIP SYSTEM
K923243 · Orthomet, Inc. · Jan 1994
APR FEMORAL HIP COMPONENT
K930812 · Intermedics Orthopedics · Nov 1993
RMHS POROUS DISTAL SLEEVE
K930108 · Smith & Nephew Richards, Inc. · Sep 1993
EXACTECH FEMORAL STEM
K925201 · Exactech, Inc. · Jun 1993
H-110 ACETABULAR CUP SYSTEM
K926323 · Implex Corp. · May 1993