Cleared Traditional

K852397 - EXTERNAL FIXATION SYSTEM(CAT. # SERIAS ...

K852397 is the FDA 510(k) clearance for EXTERNAL FIXATION SYSTEM(CAT. # SERIAS ... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K852397 · Howmedica Corp. · Orthopedic device
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Aug 1985
Decision
64d
Days
Class 2
Risk

K852397 is an FDA 510(k) clearance for the EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129). Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 64 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K852397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date August 09, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
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.

Device Classification

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 43
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K852397.
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098 · Synthes (Usa) · Apr 1990
ACE WIRE TENSION CLAMP
K894982 · Buckman Co., Inc. · Jan 1990
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · Kirschner Medical Corp. · Jul 1988
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343 · Zimmer, Inc. · Sep 1984
RICHARDS FIXATOR SYSTEM
K841334 · Richards Medical Co., Inc. · May 1984
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · Johnson & Johnson Professionals, Inc. · Oct 1983