The AmorChem 3.8 mm Headless Porous Titanium Compression Screw is used for fixation of bone fractures, bone reconstruction, and fixation of osteotomies.

Device Description

The AmorChem Porous Titanium Fixation Device is a 3.8mm, 15mm long variable pitch, fully threaded, cannulated, and headless compression screw. The AmorChem screw is designed to be inserted into a pre-drilled hole that can be guided with a standard k-wire or Allen-drive k-wire. The headless design is intended to be seated flush with the surface of bone. The device is 40% titanium with interconnected porosity. The AmorChem device is provided clean, not sterile, and is single-use only.

AI/ML Overview

The AmorChem Porous Titanium Fixation Device is a medical device designed for bone fixation. The provided document is a 510(k) summary, which evaluates the device's substantial equivalence to legally marketed predicate devices rather than proving its performance against pre-defined acceptance criteria in a clinical study. Therefore, comprehensive information regarding acceptance criteria, sample sizes for test sets, expert consensus, adjudication methods, MRMC studies, or training sets for an AI device is not applicable to this document.

However, the document does contain information about performance testing conducted to demonstrate substantial equivalence to predicate devices. Below is a summary of the performance characteristics and comparative results:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission demonstrating substantial equivalence, explicit "acceptance criteria" in the sense of predefined thresholds for clinical efficacy or diagnostic accuracy are not presented. Instead, the device's performance was compared to established predicate devices using in-vitro and in-vivo biomechanical and biocompatibility tests. The "reported device performance" reflects these comparative results.

Test Category	Acceptance Criteria (Implicit: Comparable or Superior to Predicates)	Reported AmorChem Porous Titanium Fixation Device Performance
Biomechanical (In-vitro)
Torsional Properties, Torque-in, Torque-out, Holding Strength (ASTM F 543 and F 2502)	Comparable or superior to Acumed predicate device (for torque-in/out), superior holding power to k-wire primary-predicate device.	- Possessed similar torque-in and -out properties as the Acumed predicate device.
		- Demonstrated superior holding power to the k-wire primary-predicate device.
Static and Fatigue 3-Point Bend Testing (ASTM F1264 and F1541)	Substantially stronger than the primary-predicate k-wire device.	- Found to be substantially stronger in 3-point bending than the primary-predicate k-wire device.
Biocompatibility (In-vitro & In-vivo)
Chemical Characterization and Risk Assessment (ISO 10993-1, -5, -6, -12, -17, -18, ISO 14971: 2012, FDA G-95-1, USP Physiochemical Tests)	Levels of residual compounds below detectable levels or presenting no risk of safety. Locally, no adverse effects.	- Chemical analysis showed levels of residual compounds to be below detectable levels, or presenting no risk of safety.
		- ISO 10993-6 evaluation showed no adverse effects.
	Assessed suitability for permanent implantation.	- The porous titanium material and subject device were found to be biocompatible for permanent implantation.
Biological Fixation (Ovine model at 6- and 12-weeks post-op)	Biological fixation via interconnected porous structure and cannula.	- The subject device was shown to be biologically fixed via the interconnected porous structure and cannula of the device at 6- and 12-weeks post-op.

Detailed Information (Not Applicable or Extracted where possible):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for specific tests (e.g., number of devices tested for mechanical properties, number of animals in ovine model). The document refers to "in-vitro" and "in-vivo laboratory testing."
Data Provenance: Not specified regarding country of origin. The in-vivo testing involved an "ovine model," which implies prospective animal studies. In-vitro testing is laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable as this is not a study requiring expert readers/interpreters in the described clinical context for a "ground truth" establishment. The ground truth (or assessment) for mechanical properties comes from lab measurements, and for biocompatibility and biological fixation, it comes from standard histological and toxicological analyses conducted by specialized labs (NAMSA, AccelLAB).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (bone fixation screw) and its substantial equivalence, not an AI or diagnostic imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For Biomechanical Tests: Measured physical properties based on standardized laboratory methods (ASTM F 543, F 2502, F1264, F1541) and comparison to predicate device measurements.
For Biocompatibility: Chemical analysis results (leachables/extractables, toxicological risk assessment), and histological evaluation (local tissue effects) as per ISO 10993 standards.
For Biological Fixation: Histological and potentially imaging assessments from the ovine model at 6- and 12-weeks post-op, demonstrating tissue ingrowth into the porous structure.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

Amorchem Holdings, Inc. % Robert Poggie, Ph.D. President, BioVera, Inc. 65 Promenade Saint Louis Notre Dame De Lile Perrot, Québec, J7V7P2 Canada

Re: K160791

Trade/Device Name: Amorchem Porous Titanium Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: October 12, 2016 Received: October 13, 2016

Dear Dr. Poggie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160791

Device Name

AmorChem Porous Titanium Fixation Device

Indications for Use (Describe)

The AmorChem 3.8 mm Headless Porous Titanium Compression Screw is used for fixation of bone fractures, bone reconstruction, and fixation of osteotomies.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

| X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

AmorChem Porous Titanium Fixation Device

In accordance with 21 CFR 807.92, the following information is a summary of safety and effectiveness for the AmorChem Porous Titanium Fixation Device.

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Québec,J7V 7P2, CANADA
Contact Person:	Robert A Poggie, PhD
Title:	President
Phone Number:	(514) 901-0796; (514) 349-7226
Fax Number:	(514) 901-0796
Date of Submission:	November 14, 2016

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	AmorChem Holdings, Inc.
Manufacturer Address:	1, Westmont SquareMontreal, Quebec, H3Z 2P9 Canada
Registration Number:	Not registered
Contact Name:	Kevin McBride, MsC, PhD
Title:	Vice President, Research
Device Trade Name:	AmorChem Porous Titanium Fixation Device
Device Common Name:	Metallic bone screw
Classification Name:	Smooth or threaded metallic bone fixation fastener
Classification Code:	HWC, HTY ">– Class II
Classification Panel:	Orthopedic
Regulation Number:	21 CFR section 888.3040

C1. PREDICATE DEVICES

K143618	Zimmer Kirschner Wires and Steinmann pins
Primary predicate
K930834	Acutract compression screw
Additional predicate
K102528	N-Force Fixation System
Additional predicate

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C2. REFERENCE DEVICES

K071616	The ARC Surgical BIOTRAK Pin System
K041189	The Arthrex Trimlt family
K140879	Smith & Nephew BIOSURE HEALICOIL PK Interference Screw

D. DEVICE DESCRIPTION

Materials: Porous titanium.

E. INDICATIONS FOR USE

The AmorChem 3.8 mm Headless Porous Titanium Compression Screw is used for fixation of bone fractures, bone reconstruction, and fixation of osteotomies.

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The subject AmorChem Porous Titanium Fixation Device is a 3.8mm, 15mm long variable pitch, fully threaded, cannulated, and headless compression screw made entirely of 40% porous titanium. The characteristics of variable pitch thread, tapered design, through-cannulation, and size of the AmorChem device are the same as the predicate Acumed device. The main technological differences are the porous titanium and hexagonal drive along the entire length of the AmorChem device; the Acumed device is fabricated from titanium alloy with the hex drive confined to the proximal end of the screw.

The porous titanium material is intended to allow biological fixation. In vitro testing per ASTM F543, 3-point static and fatigue bend testing, ISO 10993 evaluation of cytotoxicity, chemistry and associated risk analysis, and evaluation of biological fixation and biocompatibility in ovine models of gap healing, osteonecrosis, and cortical bone showed the AmorChem device to be substantially equivalent to the predicate devices.

G. PERFORMANCE DATA

Characterization of the AmorChem Porous Titanium Fixation Device was performed per in-vitro and in-vivo laboratory testing, and assessment of biocompatibility per the chemical characterization and risk analysis route described in ISO 10993-1 and recommended by FDA in pre-submission Q150543. More specifically:

. Biomechanical evaluation of the AmorChem device was evaluated for torsional properties, torque-in, torque-out, and holding strength per consensus testing standards ASTM F 543 and F 2502. The results of these tests showed the AmorChem device to

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possess similar torque-in and -out properties as the Acumed predicate device, superior holding power to the k-wire primary-predicate device.

Strength of the subject AmorChem device and the k-wire primary-predicate device was . evaluated in static and fatigue 3-point bend testing using ASTM F1264 and ASTM F1541 as guides. The AmorChem device was found to be substantially stronger in 3-point bending than the primary-predicate k-wire device.
Biocompatibility was assessed by quantifying the presence of leachables / extractables and toxicological risk assessment by NAMSA per ISO 10993-1, -5, -6, -12, -17, and -18, ISO 14971: 2012, FDA G-95-1 Bluebook quidance, and USP Physiochemical Tests. The chemical analysis showed the levels of residual compounds to be below detectable levels, or presenting no risk of safety. ISO 10993-6 evaluation of local tissue effects by AccelLAB of the subject device showed no adverse effects. The porous titanium material and subject device were found to be biocompatible for permanent implantation.
Ovine modeling of biological fixation and biocompatibility at 6- and 12-weeks post-op . showed the subject AmorChem Porous Titanium Fixation Device to be biologically fixed via the interconnected porous structure and cannula of the device.

The results of the performance testing indicate the AmorChem Porous Titanium Fixation Device to be substantially equivalent to the identified predicate devices.

H. CONCLUSION

The AmorChem Porous Titanium Fixation Device is substantially equivalent to the predicate devices cited in this 510(k) application.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.