Cleared Traditional

K944561 - MICRO OSTEOSYNTHESIS SYSTEM (1.0)

K944561 is an FDA 510(k) clearance for MICRO OSTEOSYNTHESIS SYSTEM (1.0), manufactured by KLS-Martin L.P.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K944561 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
32d
Days
Class 2
Risk

K944561 is an FDA 510(k) clearance for the MICRO OSTEOSYNTHESIS SYSTEM (1.0). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Washington, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 32 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.

FDA 510(k) Submission Details - K944561

510(k) Number K944561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1994
Decision Date October 18, 1994
Days to Decision 32 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
96d faster than avg
Panel avg: 128d · This submission: 32d
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 293
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K944561.
KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM
K950045 · Karl Leibinger GmbH U. Co. KG · Mar 1995
THE TITANIUM FIXATION SYSTEM
K943071 · Biomedics · Jan 1995
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K944560 · KLS-Martin L.P. · Oct 1994
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
K944565 · KLS-Martin L.P. · Oct 1994
MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM
K943345 · Patton, Boggs & Blow · Oct 1994
MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM
K943346 · Patton, Boggs & Blow · Oct 1994
K944561 · MICRO OSTEOSYNTHESIS SYSTEM (1.0)
Download PDF FDA Summary KLS-Martin L.P.