Cleared Traditional

K925348 - IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM

K925348 is an FDA 510(k) clearance for IMPLEX H-110 AND H-120 CEMENTED HIP STE..., manufactured by Implex Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K925348 · Implex Corp. · Orthopedic device
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May 1993
Decision
202d
Days
Class 2
Risk

K925348 is an FDA 510(k) clearance for the IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 202 days - an extended review 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: 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 Implex Corp. devices

FDA 510(k) Submission Details - K925348

510(k) Number K925348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date May 12, 1993
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 122d · This submission: 202d
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 514
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K925348.
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
STABILITY HIP FEMORAL COMPONENT
K915594 · Depuy, Inc. · Apr 1993
RMHS MONOLITHIC FEMORAL COMPONENT
K923275 · Smith & Nephew Richards, Inc. · Apr 1993
PERFECTA TOTAL HIP SYSTEM
K922847 · Orthomet, Inc. · Apr 1993