Cleared Traditional

K180087 - A.M. Surgical Intramedullary Fixation Device

K180087 is an FDA 510(k) clearance for A.M. Surgical Intramedullary Fixation D..., manufactured by A.M. Surgical, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K180087 · A.M. Surgical, Inc. · Orthopedic device
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May 2018
Decision
126d
Days
Class 2
Risk

K180087 is an FDA 510(k) clearance for the A.M. Surgical Intramedullary Fixation Device. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by A.M. Surgical, Inc. (Smithtown, US). The FDA issued a Cleared decision on May 18, 2018 after a review of 126 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 - K180087

510(k) Number K180087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2018
Decision Date May 18, 2018
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 158
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