Cleared Traditional

K014199 - SURGICAL SIMPLEX P WITH TOBRAMYCIN

K014199 is the FDA 510(k) clearance for SURGICAL SIMPLEX P WITH TOBRAMYCIN by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LOD) cleared through the Traditional 510(k) pathway after a 501-day FDA review.

K014199 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
501d
Days
Class 2
Risk

K014199 is an FDA 510(k) clearance for the SURGICAL SIMPLEX P WITH TOBRAMYCIN. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 501 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K014199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date May 06, 2003
Days to Decision 501 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
379d slower than avg
Panel avg: 122d · This submission: 501d
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 51
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K014199.
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · Smith & Nephew, Inc. · Nov 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · DePuy Orthopaedics, Inc. · Sep 2003
CEMEX SYSTEM FAST
K031430 · Exactech, Inc. · May 2003
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