Cleared Traditional

K093833 - KAPSS SPINAL SYSTEM

K093833 is an FDA 510(k) clearance for KAPSS SPINAL SYSTEM, manufactured by Robert Reid, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K093833 · Robert Reid, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
305d
Days
Class 2
Risk

K093833 is an FDA 510(k) clearance for the KAPSS SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Robert Reid, Inc. (Chesterland, US). The FDA issued a Cleared decision on October 15, 2010 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Robert Reid, Inc. devices

FDA 510(k) Submission Details - K093833

510(k) Number K093833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2009
Decision Date October 15, 2010
Days to Decision 305 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
183d slower than avg
Panel avg: 122d · This submission: 305d
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 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K093833.
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
RANGE SPINAL SYSTEM
K100851 · K2m, Inc. · Aug 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · Corentec Co., Ltd. · Apr 2010