Cleared Traditional

K944565 - KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1...

K944565 is the FDA 510(k) clearance for KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1... by KLS-Martin L.P.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K944565 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
32d
Days
Class 2
Risk

K944565 is an FDA 510(k) clearance for the KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM). 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.

View all KLS-Martin L.P. devices

Submission Details

510(k) Number K944565 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
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K944565.
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
K950595 · Howmedica Corp. · Jul 1995
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K944560 · KLS-Martin L.P. · Oct 1994
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · KLS-Martin L.P. · Oct 1994
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · Aesculap, Inc. · Feb 1994
LORENZ 1.0 MM SYSTEM
K922741 · Walter Lorenz Surgical, Inc. · Dec 1992
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991