Cleared Traditional

K101808 - SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TI...

K101808 is the FDA 510(k) clearance for SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TI... by Medshape Solutions. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K101808 · Medshape Solutions · Orthopedic device
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Nov 2010
Decision
132d
Days
Class 2
Risk

K101808 is an FDA 510(k) clearance for the SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) .... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medshape Solutions (Atlanta, US). The FDA issued a Cleared decision on November 8, 2010 after a review of 132 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 Medshape Solutions devices

Submission Details

510(k) Number K101808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2010
Decision Date November 08, 2010
Days to Decision 132 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 122d · This submission: 132d
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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K101808.
LOW PROFILE SCREWS
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K102298 · Depuy Mitek, A Johnson & Johnson Company · Jan 2011
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