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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

BioVera, Inc.
ROBERT A POGGIE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160791.
4.0 and 6.5 Cancellous Bone Screw and Washer
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Tyber Medical BioTy® Nanotopography Trauma Screw
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HammerTech Fixation System
K161449 · Fusion Orthopedics, LLC · Oct 2016
I.B.S. 2.0 Osteosynthesis screw
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The Hammertoe Correction System
K153065 · Life Spine, Inc. · Aug 2016