Cleared Traditional

K060180 - BIOSET XC

K060180 is an FDA 510(k) clearance for BIOSET XC, manufactured by Regeneration Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K060180 · Regeneration Technologies, Inc. · Orthopedic device
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Sep 2006
Decision
226d
Days
Class 2
Risk

K060180 is an FDA 510(k) clearance for the BIOSET XC. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Regeneration Technologies, Inc. (Alachua, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 226 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 Regeneration Technologies, Inc. devices

FDA 510(k) Submission Details - K060180

510(k) Number K060180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2006
Decision Date September 06, 2006
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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 - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 20
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K060180.
DBX STRIP
K062205 · Musculoskeletal Transplant Foundation · Feb 2007
PROGENIX DBM PUTTY AND PASTE
K060794 · Medtronic Sofamor Danek · Dec 2006
OPTECURE +CCC
K061668 · Exactech, Inc. · Sep 2006
AFT ALLOGRAFT FILLER TUBE
K060161 · Musculoskeletal Transplant Foundation · Mar 2006
OPTECURE
K050806 · Exactech, Inc. · Feb 2006
OSTEOSET DBM PELLETS
K053642 · Wrightmedicaltechnologyinc · Jan 2006