Cleared Traditional

CONNEXX LOCKING TIBIA NAIL (K080706) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080706 · I.T.S. Implantat-Technologie-Systeme GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
89d
Days
Class 2
Risk

K080706 is an FDA 510(k) clearance for the CONNEXX LOCKING TIBIA NAIL. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by I.T.S. Implantat-Technologie-Systeme GmbH (Prior Lake, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 89 days - a notably fast clearance cycle.

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: 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 I.T.S. Implantat-Technologie-Systeme GmbH devices

Submission Details

510(k) Number K080706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2008
Decision Date June 09, 2008
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 35
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K080706.
WIN Flexible Nail System
K193533 · Biomet, Inc. · Feb 2020
CHINA NAILS AND ACCESSORIES
K123948 · Smith & Nephew, Inc. · Mar 2013
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · Synthes (Usa) · Dec 2011
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
K072095 · Synthes (Usa) · Sep 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
K062872 · Synthes (Usa) · Mar 2007
KNEE FUSION NAIL
K061783 · Smith & Nephew, Inc. · Aug 2006