Cleared Traditional

K023564 - OSSE-LIGN

K023564 is an FDA 510(k) clearance for OSSE-LIGN, manufactured by Osseus, LLC. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K023564 · Osseus, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
139d
Days
Class 2
Risk

K023564 is an FDA 510(k) clearance for the OSSE-LIGN. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Osseus, LLC (Lawrenceville, US). The FDA issued a Cleared decision on March 11, 2003 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Osseus, LLC devices

FDA 510(k) Submission Details - K023564

510(k) Number K023564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2002
Decision Date March 11, 2003
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 103
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K023564.
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · Kinamed, Inc. · Oct 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · Synthes (Usa) · May 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · Smith & Nephew, Inc. · May 2003
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
SPL CRIMP SYSTEM
K002110 · Pioneer Surgical Technology · Oct 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · Pioneer Surgical Technology · Aug 2000