Cleared Traditional

K982545 - BMP CABLE SYSTEM

K982545 is an FDA 510(k) clearance for BMP CABLE SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982545 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
90d
Days
Class 2
Risk

K982545 is an FDA 510(k) clearance for the BMP CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 19, 1998 after a review of 90 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K982545

510(k) Number K982545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date October 19, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 111
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K982545.
SDB CERCLAGE SYSTEM
K992616 · Pioneer Surgical Technology · Oct 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
K983976 · Metagen, LLC · Dec 1998
CABLE SCREW WITH INTEGRAL CRIMP
K980690 · Pioneer Surgical Technology · May 1998
CERCLAGE CABLE WITH HEX BUTTON
K974016 · Pioneer Surgical Technology · Dec 1997
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
K974020 · Spinal Concepts, Inc. · Dec 1997