Cleared Traditional

K102689 - CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM

K102689 is an FDA 510(k) clearance for CONVENTUS ORTHOPAEDICS FRACTURE FIXATIO..., manufactured by Conventus Orthopaedics. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 853-day FDA review.

K102689 · Conventus Orthopaedics · Orthopedic device
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Jan 2013
Decision
853d
Days
Class 2
Risk

K102689 is an FDA 510(k) clearance for the CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Conventus Orthopaedics (Washington, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 853 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Conventus Orthopaedics devices

FDA 510(k) Submission Details - K102689

510(k) Number K102689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2010
Decision Date January 17, 2013
Days to Decision 853 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
731d slower than avg
Panel avg: 122d · This submission: 853d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K102689.
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
K121826 · Ascension Orthopedics, Inc. · Feb 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · Smith & Nephew, Inc. · Jan 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122310 · Skeletal Dynamics, LLC · Jan 2013
INTEGRA TOTAL FOOT SYSTEMS
K123000 · Integra LifeSciences Corporation · Dec 2012
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203 · Orthohelix Surgical Designs, Inc. · Dec 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495 · Aap Implantate AG · Dec 2012