Cleared Special

K011910 - IN-FAST BONE SCREW SYSTEM

K011910 is an FDA 510(k) clearance for IN-FAST BONE SCREW SYSTEM, manufactured by American Medical Systems, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 24-day FDA review.

K011910 · American Medical Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2001
Decision
24d
Days
Class 2
Risk

K011910 is an FDA 510(k) clearance for the IN-FAST BONE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on July 13, 2001 after a review of 24 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 American Medical Systems, Inc. devices

FDA 510(k) Submission Details - K011910

510(k) Number K011910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2001
Decision Date July 13, 2001
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K011910.
MODIFICATION TO THE I.C.O.S SCREW
K011821 · New Deal, S.A. · Sep 2001
THE SPIN SNAP-OFF SCREW
K011946 · New Deal, S.A. · Aug 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · Aesculap, Inc. · Aug 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · Osteomed Corp. · Jul 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · Plus Orthopedics · Jul 2001
MODIFICATION TO THE BOLD SCREW
K011262 · New Deal, S.A. · Jun 2001