Cleared Traditional

K090241 - SYNTHES ANGULAR STABLE LOCKING SYSTEM (...

K090241 is the FDA 510(k) clearance for SYNTHES ANGULAR STABLE LOCKING SYSTEM (... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K090241 · Synthes (Usa) · Orthopedic device
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Jun 2009
Decision
135d
Days
Class 2
Risk

K090241 is an FDA 510(k) clearance for the 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 June 17, 2009 after a review of 135 days - within the typical 510(k) review window.

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: 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 Synthes (Usa) devices

Submission Details

510(k) Number K090241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2009
Decision Date June 17, 2009
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 K090241.
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
K092646 · Synthes (Usa) · Sep 2009
VALOR ANKLE FUSION NAIL SYSTEM
K090857 · Wrightmedicaltechnologyinc · Jul 2009
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM
K090596 · Zimmer, Inc. · Jun 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · OrthoPediatrics Corp. · Mar 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
K083497 · Zimmer, Inc. · Feb 2009
AEQUALIS HUMERAL NAIL SYSTEM
K082754 · Tornier · Jan 2009