Cleared Traditional

K953653 - LUBINUS SP II HIP SYSTEM (FDA 510(k) Clearance)

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

K953653 · Turnkey Intergration USA, Inc. · Orthopedic device
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Nov 1995
Decision
95d
Days
Class 2
Risk

K953653 is an FDA 510(k) clearance for the LUBINUS SP II HIP SYSTEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 6, 1995 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Turnkey Intergration USA, Inc. devices

Submission Details

510(k) Number K953653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1995
Decision Date November 06, 1995
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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.