Cleared Traditional

K955171 - NEXLOCK FEMORAL STEM

K955171 is an FDA 510(k) clearance for NEXLOCK FEMORAL STEM, manufactured by Nexmed, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K955171 · Nexmed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
88d
Days
Class 2
Risk

K955171 is an FDA 510(k) clearance for the NEXLOCK FEMORAL STEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Nexmed, Inc. (Palm Desert, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 88 days - a notably fast clearance cycle.

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: 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 Nexmed, Inc. devices

FDA 510(k) Submission Details - K955171

510(k) Number K955171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 09, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 47
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K955171.
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
LUBINUS SP II HIP SYSTEM
K953653 · Turnkey Intergration USA, Inc. · Nov 1995
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · Howmedica Corp. · Aug 1995
ORTHOMET TITANIUM HYBRID FEMORAL STEM
K945783 · Orthomet, Inc. · May 1995