Cleared Traditional

K081717 - TRICOS A RESORBABLE BONE SUBSTITUTE

K081717 is an FDA 510(k) clearance for TRICOS A RESORBABLE BONE SUBSTITUTE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K081717 · Baxter Healthcare Corp · Orthopedic device
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Oct 2008
Decision
114d
Days
Class 2
Risk

K081717 is an FDA 510(k) clearance for the TRICOS A RESORBABLE BONE SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on October 10, 2008 after a review of 114 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K081717

510(k) Number K081717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date October 10, 2008
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 349
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K081717.
GENEX
K082381 · Biocomposites, Ltd. · Nov 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K083033 · Orthovita, Inc. · Nov 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
K082615 · Osteotech, Inc. · Oct 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · Globus Medical, Inc. · Oct 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
K081758 · Depuy Spine, Inc. · Sep 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558 · Pioneer Surgical Technology · Aug 2008