Cleared Special

K011719 - PLUS CANCELLOUS BONE SCREWS

K011719 is an FDA 510(k) clearance for PLUS CANCELLOUS BONE SCREWS, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 28-day FDA review.

K011719 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
28d
Days
Class 2
Risk

K011719 is an FDA 510(k) clearance for the PLUS CANCELLOUS BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 28 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.

View all Plus Orthopedics devices

FDA 510(k) Submission Details - K011719

510(k) Number K011719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date July 02, 2001
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K011719.
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · Aesculap, Inc. · Aug 2001
IN-FAST BONE SCREW SYSTEM
K011910 · American Medical Systems, Inc. · Jul 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · Osteomed Corp. · Jul 2001
MODIFICATION TO THE BOLD SCREW
K011262 · New Deal, S.A. · Jun 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · Osteomed Corp. · May 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001