Cleared Traditional

K050690 - CONNEXUS

K050690 is an FDA 510(k) clearance for CONNEXUS, manufactured by Isotis Orthobiologics, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K050690 · Isotis Orthobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
112d
Days
Class 2
Risk

K050690 is an FDA 510(k) clearance for the CONNEXUS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Isotis Orthobiologics, Inc. (Irvine, US). The FDA issued a Cleared decision on July 7, 2005 after a review of 112 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 Isotis Orthobiologics, Inc. devices

FDA 510(k) Submission Details - K050690

510(k) Number K050690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2005
Decision Date July 07, 2005
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K050690.
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · Novabone Products, LLC · Nov 2005
OSTEOCURE RESORBABLE BEAD KIT
K051406 · Nexa Orthopedics, Inc. · Aug 2005
AFT
K042125 · Musculoskeletal Transplant Foundation · Jul 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262 · Musculoskeletal Transplant Foundation · Mar 2005
INTERGRO DBM
K031399 · Interpore Cross Intl. · Feb 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · Depuy Spine, Inc. · Feb 2005