Cleared Traditional

K953653 - LUBINUS SP II HIP SYSTEM

K953653 is an FDA 510(k) clearance for LUBINUS SP II HIP SYSTEM, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 95-day FDA review.

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

FDA 510(k) Submission Details - K953653

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
Combination Product No
PCCP Authorized No
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.

JDG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 44
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K953653.
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
K001984 · Stelkast Company · Sep 2000
THE TAPER-FIT TOTAL HIP SYSTEM
K992234 · Corin USA · Nov 1999
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · Exactech, Inc. · Aug 1996
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · Howmedica Corp. · Aug 1995
ORTHOMET TITANIUM HYBRID FEMORAL STEM
K945783 · Orthomet, Inc. · May 1995
PROFORM CEMENTED FEMORAL COMPONENT
K951083 · Stelkast Company · May 1995