Cleared Special

K120715 - ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT

K120715 is an FDA 510(k) clearance for ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDUL..., manufactured by Zimmer GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 155-day FDA review.

K120715 · Zimmer GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
155d
Days
Class 2
Risk

K120715 is an FDA 510(k) clearance for the ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 155 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120715

510(k) Number K120715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date August 10, 2012
Days to Decision 155 days
Submission Type Special
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
33d slower than avg
Panel avg: 122d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

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 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K120715.
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · Smith & Nephew, Inc. · Oct 2012
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
K120148 · Advanced Orthopaedic Solutions, Inc. · Oct 2012
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
K121575 · Ortho Solutions Limited · Sep 2012
SYNTHES MULTILOC HUMERAL NAILING SYSTEM
K120807 · Synthes USA Products, LLC · Jul 2012
DYNA LOCKING ANKLE NAIL
K120419 · U&I Corp. · May 2012
FORCE MEDICAL IM NAIL SYSTEM
K102577 · Force Medical, Inc. · May 2012
K120715 · ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
Download PDF FDA Summary Zimmer GmbH