Cleared Traditional

K994143 - SMITH & NEPHEW EXTERNAL FIXATION SYSTEM...

K994143 is the FDA 510(k) clearance for SMITH & NEPHEW EXTERNAL FIXATION SYSTEM... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K994143 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
72d
Days
Class 2
Risk

K994143 is an FDA 510(k) clearance for the SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (.... Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. devices

Submission Details

510(k) Number K994143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date February 18, 2000
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K994143.
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · Biomet, Inc. · Nov 2000
SYNTHES SACRAL BAR SYSTEM
K001720 · Synthes (Usa) · Aug 2000
APEX FIXATION PINS
K001886 · Howmedica Osteonics Corp. · Jul 2000
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · Depuy, Inc. · Jul 1999
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · Howmedica Corp. · Aug 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186 · Orthofix Srl · Mar 1998