Cleared Traditional

GENERATION 4 BONE CEMENT (K993836) - FDA 510(k) Clearance

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

K993836 · Biomet, Inc. · Orthopedic device
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Dec 2001
Decision
768d
Days
Class 2
Risk

K993836 is an FDA 510(k) clearance for the GENERATION 4 BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 768 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 K993836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date December 19, 2001
Days to Decision 768 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
646d slower than avg
Panel avg: 122d · This submission: 768d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOD Bone Cement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - LOD Bone Cement

All 46
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K993836.
SMARTSET HV BONE CEMENT
K023012 · DePuy Orthopaedics, Inc. · Feb 2003
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · DePuy Orthopaedics, Inc. · Jul 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · Exactech, Inc. · Jun 2002
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · Exactech, Inc. · Feb 2001
VERSABOND BONE CEMENT
K001160 · Smith & Nephew, Inc. · Dec 2000