Cleared Traditional

K160791 - AmorChem Titanium Porous Fixation Device

K160791 is an FDA 510(k) clearance for AmorChem Titanium Porous Fixation Device, manufactured by Amorchem Holdings, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K160791 · Amorchem Holdings, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2016
Decision
237d
Days
Class 2
Risk

K160791 is an FDA 510(k) clearance for the AmorChem Titanium Porous Fixation Device. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Amorchem Holdings, Inc. (Montreal, CA). The FDA issued a Cleared decision on November 15, 2016 after a review of 237 days - an extended review cycle.

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 Amorchem Holdings, Inc. devices

FDA 510(k) Submission Details - K160791

510(k) Number K160791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2016
Decision Date November 15, 2016
Days to Decision 237 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 122d · This submission: 237d
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 735
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160791.
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
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