Cleared Traditional

A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM (K853709) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853709 · Downs Surgical , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
72d
Days
Class 2
Risk

K853709 is an FDA 510(k) clearance for the A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on November 15, 1985 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K853709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date November 15, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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 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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K853709.
LUHR MICRO SYSTEM
K882454 · Howmedica Corp. · Aug 1988
HOFFMANN LEG LENGTHENING PLATE SYSTEM
K870388 · Howmedica Corp. · Apr 1987
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
K860600 · 3M Company · Mar 1986
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · Synthes (Usa) · May 1984
CURVED SHERMAN BONE PLATE
K810061 · Howmedica Corp. · Jan 1981
POLYETHYLENE FILLED BONE PLATE
K801603 · Zimmer, Inc. · Oct 1980