Cleared Traditional

K970351 - GLOBAL TAPER SPECTRON HIP STEMS

K970351 is an FDA 510(k) clearance for GLOBAL TAPER SPECTRON HIP STEMS, manufactured by Smith & Nephew, Inc., Orthopaedic Div.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K970351 · Smith & Nephew, Inc., Orthopaedic Div. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
29d
Days
Class 2
Risk

K970351 is an FDA 510(k) clearance for the GLOBAL TAPER SPECTRON HIP STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc., Orthopaedic Div. (Memphis, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 29 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 Smith & Nephew, Inc., Orthopaedic Div. devices

FDA 510(k) Submission Details - K970351

510(k) Number K970351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1997
Decision Date February 28, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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 467
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K970351.
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K970194 · Stelkast Company · Apr 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · Corin USA · Mar 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · Johnson & Johnson Professionals, Inc. · Feb 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · Howmedica Corp. · Feb 1997
HEDROCEL ACETABULAR RESTRICTOR
K962468 · Implex Corp. · Feb 1997