Cleared Traditional

BF+ (K043347) - FDA 510(k) Clearance

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

K043347 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
32d
Days
Class 2
Risk

K043347 is an FDA 510(k) clearance for the BF+. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Ldr Spine USA devices

Submission Details

510(k) Number K043347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date January 07, 2005
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 190
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K043347.
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
ALLOMATRIX PUTTY
K041168 · Wrightmedicaltechnologyinc · Aug 2004
NORIAN SRS FAST SET PUTTY
K041842 · Synthes (Usa) · Jul 2004