Cleared Traditional

K010586 - PALAMED BONE CEMENT

K010586 is an FDA 510(k) clearance for PALAMED BONE CEMENT, manufactured by Merck Biomaterial GmbH. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K010586 · Merck Biomaterial GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
245d
Days
Class 2
Risk

K010586 is an FDA 510(k) clearance for the PALAMED BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Merck Biomaterial GmbH (Darmstadt, DE). The FDA issued a Cleared decision on October 30, 2001 after a review of 245 days - an extended review cycle.

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. Standard predicate reliance. 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 Merck Biomaterial GmbH devices

FDA 510(k) Submission Details - K010586

510(k) Number K010586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2001
Decision Date October 30, 2001
Days to Decision 245 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 122d · This submission: 245d
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 61
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K010586.
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
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · Exactech, Inc. · Feb 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