Cleared Traditional

K121235 - LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM

K121235 is an FDA 510(k) clearance for LEIBINGER ADVANCE INTERNAL MIDFACE DIST..., manufactured by Stryker. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 625-day FDA review.

K121235 · Stryker · Dental device
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Jan 2014
Decision
625d
Days
Class 2
Risk

K121235 is an FDA 510(k) clearance for the LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 625 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Stryker devices

FDA 510(k) Submission Details - K121235

510(k) Number K121235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2012
Decision Date January 09, 2014
Days to Decision 625 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
498d slower than avg
Panel avg: 127d · This submission: 625d
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 228
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K121235.
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