Cleared Traditional

K091118 - FOOT AND HAND MOTION SYSTEM

K091118 is the FDA 510(k) clearance for FOOT AND HAND MOTION SYSTEM by Newclip Technics. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K091118 · Newclip Technics · Orthopedic device
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Dec 2009
Decision
243d
Days
Class 2
Risk

K091118 is an FDA 510(k) clearance for the FOOT AND HAND MOTION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Newclip Technics (Round Rock, US). The FDA issued a Cleared decision on December 16, 2009 after a review of 243 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 Newclip Technics devices

Submission Details

510(k) Number K091118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date December 16, 2009
Days to Decision 243 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 122d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 553
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K091118.
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · TriMed, Inc. · Mar 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · Depuy Mitek, A Johnson & Johnson Company · Mar 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · Synthes (Usa) · Jan 2010
LEFORTE NEUROSYSTEM BONE SCREW
K091686 · Jeil Medical Corporation · Nov 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133 · Arthrocare Corp. · Nov 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · Synthes (Usa) · Jul 2009