Cleared Special

K111667 - SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

K111667 is an FDA 510(k) clearance for SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code JDS cleared through the Special 510(k) pathway after a 174-day FDA review.

K111667 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
174d
Days
Class 2
Risk

K111667 is an FDA 510(k) clearance for the SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on December 5, 2011 after a review of 174 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K111667

510(k) Number K111667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2011
Decision Date December 05, 2011
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Modification to existing cleared device.

JDS Device Classification - Class 2, Special Controls

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K111667.
WIN Flexible Nail System
K193533 · Biomet, Inc. · Feb 2020
CONVENTUS PHS SYSTEM
K141737 · Conventus Orthopaedics, Inc. · Apr 2015
CHINA NAILS AND ACCESSORIES
K123948 · Smith & Nephew, Inc. · Mar 2013
CONNEXX LOCKING TIBIA NAIL
K080706 · I.T.S. Implantat-Technologie-Systeme GmbH · Jun 2008
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
K072095 · Synthes (Usa) · Sep 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
K062872 · Synthes (Usa) · Mar 2007
K111667 · SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
Download PDF FDA Summary Synthes (Usa)