Cleared Traditional

K051617 - NOVABONE PUTTY - RESORBABLE BONE VOID FILLER

K051617 is an FDA 510(k) clearance for NOVABONE PUTTY - RESORBABLE BONE VOID F..., manufactured by Novabone Products, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K051617 · Novabone Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
262d
Days
Class 2
Risk

K051617 is an FDA 510(k) clearance for the NOVABONE PUTTY - RESORBABLE BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Novabone Products, LLC (Alachua, US). The FDA issued a Cleared decision on March 6, 2006 after a review of 262 days - an extended review 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: 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 Novabone Products, LLC devices

FDA 510(k) Submission Details - K051617

510(k) Number K051617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2005
Decision Date March 06, 2006
Days to Decision 262 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
140d slower than avg
Panel avg: 122d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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 435
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K051617.
NORIAN SRS BONE VOID FILLER
K060408 · Synthes (Usa) · Mar 2006
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
COLLOSS E BONE VOID FILLER
K051047 · Ossacur AG · Mar 2006
ALLOMATRIX CUSTOM
K053319 · Wrightmedicaltechnologyinc · Mar 2006
STRYKER INJECTABLE CEMENT
K060061 · Stryker Corp. · Mar 2006
MIIG SR
K060011 · Wrightmedicaltechnologyinc · Feb 2006