Cleared Traditional

K925895 - ETEX HIP REPLACEMENT SYSTEM

K925895 is an FDA 510(k) clearance for ETEX HIP REPLACEMENT SYSTEM, manufactured by Etex Co.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K925895 · Etex Co. · Orthopedic device
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Feb 1993
Decision
85d
Days
Class 2
Risk

K925895 is an FDA 510(k) clearance for the ETEX HIP REPLACEMENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Etex Co. (Cambridge, US). The FDA issued a Cleared decision on February 9, 1993 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: 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 Etex Co. devices

FDA 510(k) Submission Details - K925895

510(k) Number K925895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date February 09, 1993
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 517
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K925895.
UNIFIT FEMORAL STEM
K922871 · Osteo Technology, Inc. · Feb 1993
THE UNIVERSAL BONE CEMENT RESISTOR
K924323 · Biodynamic Technologies, Inc. · Feb 1993
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
K922733 · Orthomet, Inc. · Feb 1993
DEPUY HIP PROSTHESIS
K914078 · Depuy, Inc. · Jan 1993
LSF ANATOMIC CEMENTED HIP
K922645 · Osteo Technology, Inc. · Jan 1993
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K920739 · Joint Medical Products Corp. · Nov 1992