Cleared Traditional

K081452 - SYNTHES (USA) STAINLESS STEEL ELASTIC I...

K081452 is the FDA 510(k) clearance for SYNTHES (USA) STAINLESS STEEL ELASTIC I... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K081452 · Synthes (Usa) · Orthopedic device
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Jul 2008
Decision
56d
Days
Class 2
Risk

K081452 is an FDA 510(k) clearance for the SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM. 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 July 18, 2008 after a review of 56 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 K081452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2008
Decision Date July 18, 2008
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K081452.
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
K082770 · Zimmer, Inc. · Dec 2008
T2 FLEXIBLE NAIL
K082018 · Howmedica Osteonics Corp. · Oct 2008
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
K082148 · Synthes (Usa) · Aug 2008
T2 FEMORAL NAIL
K081152 · Howmedica Osteonics Corp. · Jun 2008
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
K073402 · Synthes (Usa) · Feb 2008
ACID ETCHED LAG SCREWS
K070955 · Biomet Orthopedics, Inc. · Oct 2007