Cleared Traditional

K053105 - SYNTHES (USA) ELASTIC INTRAMEDULLARY NA...

K053105 is the FDA 510(k) clearance for SYNTHES (USA) ELASTIC INTRAMEDULLARY NA... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K053105 · Synthes (Usa) · Orthopedic device
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Dec 2005
Decision
28d
Days
Class 2
Risk

K053105 is an FDA 510(k) clearance for the SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP. 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 December 2, 2005 after a review of 28 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 K053105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2005
Decision Date December 02, 2005
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K053105.
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
K061910 · Synthes (Usa) · Sep 2006
S2 RECON NAIL SYSTEM
K060921 · Howmedica Osteonics Corp. · Apr 2006
ORTHOFIX TITANIUM NAILING SYSTEMS
K053261 · Orthofix Srl · Dec 2005
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
K051678 · Synthes (Usa) · Sep 2005
T2 ANKLE ARTHRODESIS NAIL
K051590 · Howmedica Osteonics Corp. · Jul 2005
T2 RECON NAIL SYSTEM
K051624 · Howmedica Osteonics Corp. · Jul 2005