Cleared Traditional

K091686 - LEFORTE NEUROSYSTEM BONE SCREW

K091686 is an FDA 510(k) clearance for LEFORTE NEUROSYSTEM BONE SCREW, manufactured by Jeil Medical Corporation. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K091686 · Jeil Medical Corporation · Orthopedic device
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Nov 2009
Decision
157d
Days
Class 2
Risk

K091686 is an FDA 510(k) clearance for the LEFORTE NEUROSYSTEM BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Salt Lake City, US). The FDA issued a Cleared decision on November 13, 2009 after a review of 157 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Jeil Medical Corporation devices

FDA 510(k) Submission Details - K091686

510(k) Number K091686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date November 13, 2009
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1016
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K091686.
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
K092754 · Small Bone Innovations, Inc. · Jan 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · Synthes (Usa) · Jan 2010
FOOT AND HAND MOTION SYSTEM
K091118 · Newclip Technics · Dec 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133 · Arthrocare Corp. · Nov 2009
ASCENSION CANNULATED SCREW SYSTEM
K092440 · Ascension Orthopedics, Inc. · Nov 2009
SYNERGY CANNULATED SCREW SYSTEM
K092082 · Synergy Surgical Technologies, LLC · Oct 2009