Cleared Traditional

K101700 - IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM

K101700 is an FDA 510(k) clearance for IO FIX HAND, manufactured by Extremity Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K101700 · Extremity Medical, LLC · Orthopedic device
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Oct 2010
Decision
117d
Days
Class 2
Risk

K101700 is an FDA 510(k) clearance for the IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on October 12, 2010 after a review of 117 days - within the typical 510(k) review window.

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 Extremity Medical, LLC devices

FDA 510(k) Submission Details - K101700

510(k) Number K101700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2010
Decision Date October 12, 2010
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 985
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K101700.
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
K102162 · Parcus Medical, LLC · Nov 2010
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
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PIONEER CANNULATED SCREW SYSTEM
K102903 · Pioneer Surgical Technology, Inc. · Oct 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
K101696 · Zimmer, Inc. · Sep 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165 · Wrightmedicaltechnologyinc · Jul 2010
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
K101254 · Tecnologia Y Diseno Industrial, S.A DE C.V · Jul 2010