Cleared Traditional

K974911 - EXTERNAL FIXATOR

K974911 is an FDA 510(k) clearance for EXTERNAL FIXATOR, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K974911 · Avanta Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
75d
Days
Class 2
Risk

K974911 is an FDA 510(k) clearance for the EXTERNAL FIXATOR. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 16, 1998 after a review of 75 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 Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K974911

510(k) Number K974911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1997
Decision Date March 16, 1998
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K974911.
EXTERNAL FIXATION
K981716 · Avanta Orthopaedics, Inc. · Jul 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788 · Alphatec Mfg., Inc. · May 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186 · Orthofix Srl · Mar 1998
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · Synthes (Usa) · Mar 1997
HANSSON PIN SYSTEM
K964893 · Osteonics Corp. · Feb 1997
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · Depuy, Inc. · Dec 1996