Cleared Traditional

EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE (K011386) - FDA 510(k) Clearance

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

K011386 · Ebi, L.P. · Orthopedic device
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Aug 2001
Decision
88d
Days
Class 2
Risk

K011386 is an FDA 510(k) clearance for the EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on August 3, 2001 after a review of 88 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 Ebi, L.P. devices

Submission Details

510(k) Number K011386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date August 03, 2001
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 195
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K011386.
NORIAN SRS BONE VOID FILLER
K011897 · Synthes (Usa) · Dec 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · DePuy Orthopaedics, Inc. · Nov 2001
OSTEOSET BVF KIT
K010532 · Wrightmedicaltechnologyinc · Oct 2001
JAX GRANULES BONE VOID FILLER
K010557 · Smith & Nephew, Inc. · May 2001
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362 · Synthes (Usa) · Nov 2000
CALCIUM SULFATE PELLETS
K001559 · Howmedica Osteonics Corp. · Jun 2000