Cleared Traditional

K000943 - CEMEX SYSTEM GUN APPLICATION VERSION

K000943 is an FDA 510(k) clearance for CEMEX SYSTEM GUN APPLICATION VERSION, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K000943 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
322d
Days
Class 2
Risk

K000943 is an FDA 510(k) clearance for the CEMEX SYSTEM GUN APPLICATION VERSION. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on February 8, 2001 after a review of 322 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Exactech, Inc. devices

FDA 510(k) Submission Details - K000943

510(k) Number K000943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2000
Decision Date February 08, 2001
Days to Decision 322 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
200d slower than avg
Panel avg: 122d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K000943.
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
GENERATION 4 BONE CEMENT
K993836 · Biomet, Inc. · Dec 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652 · Stryker Corp. · Jan 2001
VERSABOND BONE CEMENT
K001160 · Smith & Nephew, Inc. · Dec 2000