Cleared Traditional

K974309 - LACTOSORB PANELS

K974309 is the FDA 510(k) clearance for LACTOSORB PANELS by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K974309 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
74d
Days
Class 2
Risk

K974309 is an FDA 510(k) clearance for the LACTOSORB PANELS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 74 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 Biomet, Inc. devices

Submission Details

510(k) Number K974309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date January 30, 1998
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 945
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K974309.
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · Depuy, Inc. · Apr 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · Synthes (Usa) · Mar 1998
EPI-UNION PLATING SYSTEM
K974289 · Howmedica, Inc. · Feb 1998
TIMESH SYSTEM
K974017 · Sofamor Danek USA,Inc. · Jan 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · Howmedica, Inc. · Jan 1998
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · Osteonics Corp. · Dec 1997