Cleared Traditional

BMP CABLE SYSTEM (K982545) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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 52
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K982545.
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741 · Howmedica Corp. · Jul 1997
DALL-MILES TROCHANTER CABLE SUPERGRIP
K962162 · Howmedica Corp. · Aug 1996
SILKON STAINLESS STEEL CABLE SYSTEM
K962132 · Osteonics Corp. · Aug 1996