Cleared Traditional

K121682 - ACTIVE SCREW BONE SCREW

K121682 is an FDA 510(k) clearance for ACTIVE SCREW BONE SCREW, manufactured by Intelligent Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K121682 · Intelligent Implant Systems, LLC · Orthopedic device
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Oct 2012
Decision
119d
Days
Class 2
Risk

K121682 is an FDA 510(k) clearance for the ACTIVE SCREW BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Intelligent Implant Systems, LLC (Charlotte, US). The FDA issued a Cleared decision on October 4, 2012 after a review of 119 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 Intelligent Implant Systems, LLC devices

FDA 510(k) Submission Details - K121682

510(k) Number K121682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2012
Decision Date October 04, 2012
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 1019
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K121682.
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K122738 · Solana Surgical, LLC · Nov 2012
HAMMER TOE IMPLANT
K122959 · Trilliant Surgical, Ltd. · Nov 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
K122031 · Nextremity Solutions, LLC · Oct 2012
PMT BONE SCREWS
K121713 · Providence Medical Technology, Inc. · Sep 2012
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
K121148 · Medical Design, LLC · Aug 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · Extremity Medical, LLC · Jul 2012