Cleared Traditional

LACTOSORB PANELS AND FASTENERS (K984390) - FDA 510(k) Clearance

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

K984390 · Biomet, Inc. · Orthopedic device
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Aug 2000
Decision
608d
Days
Class 2
Risk

K984390 is an FDA 510(k) clearance for the LACTOSORB PANELS AND FASTENERS. 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 August 7, 2000 after a review of 608 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Orthopedic submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K984390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date August 07, 2000
Days to Decision 608 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
486d slower than avg
Panel avg: 122d · This submission: 608d
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 K984390.
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
K002710 · Synthes (Usa) · Sep 2000
SYNTHES MODULAR FOOT SYSTEM
K001941 · Synthes (Usa) · Sep 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945 · Synthes (Usa) · Sep 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311 · Synthes (Usa) · Jun 2000
STRYKER TRAUMA PLATING SYSTEM
K000636 · Howmedica Osteonics Corp. · May 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066 · Synthes (Usa) · Mar 2000