Cleared Traditional

K071520 - RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

K071520 is an FDA 510(k) clearance for RENOVO SUTURE ANCHORS, manufactured by Core Essence Orthopaedics, LLC. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K071520 · Core Essence Orthopaedics, LLC · Orthopedic device
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Aug 2007
Decision
67d
Days
Class 2
Risk

K071520 is an FDA 510(k) clearance for the RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Core Essence Orthopaedics, LLC (Yardley, US). The FDA issued a Cleared decision on August 10, 2007 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Core Essence Orthopaedics, LLC devices

FDA 510(k) Submission Details - K071520

510(k) Number K071520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date August 10, 2007
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 575
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K071520.
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