Cleared Traditional

K971987 - SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR

K971987 is an FDA 510(k) clearance for SYNTHES (USA) [SYNTHES] MINI EXTERNAL F..., manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K971987 · Synthes (Usa) · Dental device
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Jun 1997
Decision
26d
Days
Class 2
Risk

K971987 is an FDA 510(k) clearance for the SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K971987

510(k) Number K971987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date June 24, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K971987.
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
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GUERRERO - BELL DISTRACTOR
K972166 · Howmedica Leibinger, Inc. · Aug 1997
IMTEC/TITANIUM MESH
K970841 · Imtec Corp. · Apr 1997
LEE PLATE
K970911 · Howmedica Leibinger, Inc. · Apr 1997
INTRAORAL MANDIBULAR DISTRACTION DEVICE
K970256 · Medicon EG · Mar 1997