Cleared Traditional

K990596 - DISTAL RADIUS FRACTURE FIXATION PLATE S...

K990596 is an FDA 510(k) clearance for DISTAL RADIUS FRACTURE FIXATION PLATE S..., manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K990596 · Avanta Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1999
Decision
64d
Days
Class 2
Risk

K990596 is an FDA 510(k) clearance for the DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 29, 1999 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K990596

510(k) Number K990596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1999
Decision Date April 29, 1999
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1045
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K990596.
LORENZ SMALL FRAGMENT SYSTEM
K992961 · Walter Lorenz Surgical, Inc. · Nov 1999
KMI WRIST FUSION SYSTEM
K991873 · Kinetikos Medical, Inc. · Aug 1999
LACTOSORB HAND SYSTEM
K991763 · Biomet, Inc. · Jul 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481 · Biodynamic Technologies, Inc. · Mar 1999
KMI WRIST FUSION SYSTEM
K990094 · Kinetikos Medical, Inc. · Feb 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · Synthes (Usa) · Jan 1999