Cleared Traditional

K992490 - B2C HIP SYSTEM

K992490 is an FDA 510(k) clearance for B2C HIP SYSTEM, manufactured by Lepine Groupe Spa.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K992490 · Lepine Groupe Spa. · Orthopedic device
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Aug 1999
Decision
24d
Days
Class 2
Risk

K992490 is an FDA 510(k) clearance for the B2C HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Lepine Groupe Spa. (Sarasota, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 24 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 Lepine Groupe Spa. devices

FDA 510(k) Submission Details - K992490

510(k) Number K992490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date August 19, 1999
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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
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