Cleared Traditional

LACTOSORB PANELS (K974309) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K974309.
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812 · Arthrex, Inc. · Jun 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · Depuy, Inc. · Apr 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · Synthes (Usa) · Mar 1998
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · Osteonics Corp. · Dec 1997
OSTEO BOS SYSTEM IN STAINLESS STEEL
K973204 · Osteonics Corp. · Sep 1997
ALTA PLATING SYSTEM
K972479 · Howmedica Corp. · Sep 1997