Cleared Traditional

K101682 - S 100 PEDICLE SCREW SYSTEM

K101682 is an FDA 510(k) clearance for S 100 PEDICLE SCREW SYSTEM, manufactured by Renovis Surgical Technologies, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K101682 · Renovis Surgical Technologies, LLC · Orthopedic device
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Dec 2010
Decision
175d
Days
Class 2
Risk

K101682 is an FDA 510(k) clearance for the S 100 PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, LLC (Round Rock, US). The FDA issued a Cleared decision on December 7, 2010 after a review of 175 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Renovis Surgical Technologies, LLC devices

FDA 510(k) Submission Details - K101682

510(k) Number K101682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2010
Decision Date December 07, 2010
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 194
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K101682.
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414 · L & K Biomed Co., Ltd. · Jul 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc. · Jul 2011
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
MOUNTAINEER OCT SPINAL SYSTEM
K103100 · Depuy Spine, Inc. · Nov 2010
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407 · Life Spine · Nov 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · Ldr Spine USA · Oct 2010