Cleared Traditional

K853709 - A RANGE OF INSTRUMENTS & PLATES FOR MAN...

K853709 is an FDA 510(k) clearance for A RANGE OF INSTRUMENTS & PLATES FOR MAN..., manufactured by Downs Surgical , Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K853709 · Downs Surgical , Ltd. · Orthopedic device
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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

FDA 510(k) Submission Details - K853709

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
Combination Product No
PCCP Authorized No
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.

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 946
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K853709.
KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM
K864924 · Kirschner Medical Corp. · Mar 1987
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
K860600 · 3M Company · Mar 1986
ACE MULTIPLE PIN PLATE
K860591 · Buckman Co., Inc. · Mar 1986
LETOURNEL ACETABULAR PLATE
K850401 · Pfizer, Inc. · Apr 1985
MEC BROAD BONE PLATE
K850442 · Pfizer, Inc. · Apr 1985
MEC BUTRESS PLATE
K850444 · Pfizer, Inc. · Apr 1985