Cleared Traditional

K981716 - EXTERNAL FIXATION

K981716 is an FDA 510(k) clearance for EXTERNAL FIXATION, 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 63-day FDA review.

K981716 · Avanta Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
63d
Days
Class 2
Risk

K981716 is an FDA 510(k) clearance for the EXTERNAL FIXATION. 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 July 17, 1998 after a review of 63 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.

FDA 510(k) Submission Details - K981716

510(k) Number K981716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date July 17, 1998
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 90
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K981716.
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
K983757 · Syntec Scientific Corp. · Dec 1998
THREADED FIXATION PIN
K982931 · Sgarlato Laboratories, Inc. · Oct 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · Howmedica Corp. · Aug 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
EXTERNAL FIXATOR
K974911 · Avanta Orthopaedics, Inc. · Mar 1998
K981716 · EXTERNAL FIXATION
Download PDF FDA Summary Avanta Orthopaedics, …