Cleared Special

K011390 - BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

K011390 is an FDA 510(k) clearance for BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM, manufactured by Disc-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 30-day FDA review.

K011390 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
30d
Days
Class 2
Risk

K011390 is an FDA 510(k) clearance for the BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Herzelia, IL). The FDA issued a Cleared decision on June 6, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011390

510(k) Number K011390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date June 06, 2001
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 606
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K011390.
METAL SCREW ANCHOR
K012503 · Biomet Manufacturing, Inc. · Oct 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · Axya Medical, Inc. · Aug 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · Arthrex, Inc. · Jun 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · Arthrex, Inc. · May 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · Dj Orthopedics, LLC · Mar 2001
DJ ORTHOPEDICS TIBIAL ANCHOR
K003960 · Dj Orthopedics, LLC · Mar 2001
K011390 · BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
Download PDF FDA Summary Disc-O-Tech Medical T…