Cleared Traditional

K982545 - BMP CABLE SYSTEM

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

K982545 · Biomet, Inc. · Orthopedic device
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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

Submission Details

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.

Device Classification

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 90
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K982545.
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
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