Cleared Traditional

K983976 - METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM

K983976 is an FDA 510(k) clearance for METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM, manufactured by Metagen, LLC. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K983976 · Metagen, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
51d
Days
Class 2
Risk

K983976 is an FDA 510(k) clearance for the METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Metagen, LLC (Menomonie, US). The FDA issued a Cleared decision on December 30, 1998 after a review of 51 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Metagen, LLC devices

FDA 510(k) Submission Details - K983976

510(k) Number K983976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date December 30, 1998
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K983976.
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999
SDB CERCLAGE SYSTEM
K992616 · Pioneer Surgical Technology · Oct 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
BMP CABLE SYSTEM
K982545 · Biomet, Inc. · Oct 1998
CABLE SCREW WITH INTEGRAL CRIMP
K980690 · Pioneer Surgical Technology · May 1998
CERCLAGE CABLE WITH HEX BUTTON
K974016 · Pioneer Surgical Technology · Dec 1997