Cleared Traditional

K061910 - SYNTHES (USA) [SYNTHES] ANGULAR STABLE ...

K061910 is the FDA 510(k) clearance for SYNTHES (USA) [SYNTHES] ANGULAR STABLE ... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K061910 · Synthes (Usa) · Orthopedic device
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Sep 2006
Decision
77d
Days
Class 2
Risk

K061910 is an FDA 510(k) clearance for the SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS). Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on September 21, 2006 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K061910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2006
Decision Date September 21, 2006
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K061910.
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
K070294 · Synthes (Usa) · Mar 2007
BIOMET TIBIAL LOCKING NAIL SYSTEM
K063570 · Biomet Manufacturing Corp · Feb 2007
METAIZEAU NAILING SYSTEM
K063225 · Howmedica Osteonics Corp. · Dec 2006
S2 RECON NAIL SYSTEM
K060921 · Howmedica Osteonics Corp. · Apr 2006
ORTHOFIX TITANIUM NAILING SYSTEMS
K053261 · Orthofix Srl · Dec 2005
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
K053105 · Synthes (Usa) · Dec 2005