Cleared Traditional

K191771 - SECURE Screw

K191771 is an FDA 510(k) clearance for SECURE Screw, manufactured by A.M. Surgical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K191771 · A.M. Surgical, Inc. · Orthopedic device
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Oct 2019
Decision
106d
Days
Class 2
Risk

K191771 is an FDA 510(k) clearance for the SECURE Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by A.M. Surgical, Inc. (Smithtown, US). The FDA issued a Cleared decision on October 16, 2019 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 A.M. Surgical, Inc. devices

FDA 510(k) Submission Details - K191771

510(k) Number K191771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2019
Decision Date October 16, 2019
Days to Decision 106 days
Submission Type Traditional
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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 919
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K191771.
DePuy Synthes Trauma Screws
K192745 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Nov 2019
Arthrex Nano SwiveLock Suture Anchor
K191651 · Arthrex, Inc. · Nov 2019
Arthrex Low Profile Screws
K190921 · Arthrex, Inc. · Oct 2019
TDM Screw Systems
K190830 · Tdm Co., Ltd. · Sep 2019
Interphalangeal Joint Fusion Device Range
K191424 · Neosteo · Aug 2019
CrossRoads Screw System
K191342 · Crossroads Extemity Systems, LLC · Aug 2019