The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Device Description

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

The CONSTRUX Mini PEEK Ti Spacer System is not intended to be used as a stand-alone device. The CONSTRUX Mini PEEK Ti Spacer System must be used with supplemental fixation. The CONSTRUX Mini PEEK Ti implants are provided sterile.

AI/ML Overview

The CONSTRUX Mini PEEK Ti Spacer System is a medical device. The information provided does not describe a study involving artificial intelligence (AI) or machine learning. Instead, it details the regulatory submission (510(k)) for a physical medical implant. Therefore, the questions related to AI/ML performance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this document.

The document focuses on demonstrating that the CONSTRUX Mini PEEK Ti Spacer System is substantially equivalent to previously cleared predicate devices based on its design, materials, and mechanical performance.

Below is the relevant information extracted from the provided text, adapted to the requested format where applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to predicate devices through mechanical testing standards. The reported device performance indicates that these standards were met.

Characteristic / Test	Acceptance Standard / Criteria	Reported Device Performance
Mechanical Performance
Static and Dynamic Torsion Test	ASTM F2077-11 (Standard Test Method for Intervertebral Body Fusion Devices) - The device must meet the performance requirements specified in this standard for intervertebral body fusion devices.	Test results demonstrated that the device is substantially equivalent to the predicate device.
Static and Dynamic Axial Compression Test	ASTM F2077-11 (Standard Test Method for Intervertebral Body Fusion Devices) - The device must meet the performance requirements specified in this standard for intervertebral body fusion devices.	Test results demonstrated that the device is substantially equivalent to the predicate device.
Static and Dynamic Compression Shear Test	ASTM F2077-11 (Standard Test Method for Intervertebral Body Fusion Devices) - The device must meet the performance requirements specified in this standard for intervertebral body fusion devices.	Test results demonstrated that the device is substantially equivalent to the predicate device.
Subsidence Test	ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device) - The device must meet the performance requirements for subsidence as specified in this standard.	Test results demonstrated that the device is substantially equivalent to the predicate device.
Material Composition
Polyetheretherketone (PEEK) and Titanium alloy (Ti-6Al-4V)	The material composition of the subject device (PEEK core with integrated porous Titanium end plates) must be comparable to the predicate devices (one using PEEK and commercially pure Titanium; another using Titanium alloy).	The device uses Polyetheretherketone and Titanium alloy (Ti-6Al-4V), which is similar and considered substantially equivalent to the predicate devices' materials.
Intended Use / Indications for Use
Spinal fusion at one level (C2-T1) in skeletally mature DDD patients, with autograft and supplemental fixation.	The intended use of the device must align with the predicate devices, for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD), to be used with autograft and supplemental fixation.	The intended use is identical to the predicate CONSTRUX Mini PEEK Spacer System's and similar to the Titan Spine Endoskeleton TC.
Method of Fixation	The device must be an intervertebral body fusion (IBD) spacer used with autograft and supplemental fixation.	IBD spacer used with autograft and supplemental fixation.
Implantation Approach	The device must be implanted via an anterior approach.	Anterior approach.
Design	The device must be a hollow cage design.	Hollow cage.
Profile	The device must have a parallel and lordotic profile.	Parallel and lordotic.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical mechanical testing of the device prototypes, not a study involving a test set of data in the context of AI/ML.

Sample Size: The document does not specify the exact number of units tested for each mechanical test (e.g., how many spacers were subjected to torsion tests). This information is typically found in detailed test reports, not summary submissions.
Data Provenance: Not applicable. The "data" refers to the results of in vitro mechanical tests conducted on the physical device, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the submission pertains to a physical medical device and its mechanical performance, not an AI/ML model where "ground truth" is established by human experts reviewing medical data. The "ground truth" for mechanical testing is defined by the performance standards themselves (e.g., ASTM F2077-11 requirements).

4. Adjudication Method for the Test Set

This question is not applicable as the submission pertains to mechanical testing of a physical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML ground truth establishment, not for non-clinical engineering tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This question is not applicable. The submission is for a physical medical implant and focuses on demonstrating substantial equivalence through mechanical testing, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the document describes a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the CONSTRUX Mini PEEK Ti Spacer System's performance is established by the requirements and methodologies outlined in the referenced ASTM standards (ASTM F2077-11 and ASTM F2267-04). These standards define the acceptable mechanical properties and behaviors (e.g., static and dynamic strength, subsidence resistance) that an intervertebral body fusion device must demonstrate. The device is considered to meet the "ground truth" if its test results comply with these engineering standards and demonstrate equivalence to predicate devices that have already met these standards.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the document describes a physical medical device, not an AI/ML model.

Summary

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510(k) SUMMARY

NOV 2-9 2012

CONSTRUX Mini® PEEK Ti Spacer System

Submitter Information
Name:	Orthofix Inc.
Address:	3451 Plano Parkway
	Lewisville, TX 75056
Telephone Number:	214.937.2000
Fax Number:	214-937-3322
Email:	nataliavolosen@orthofix.com
Registration Number:	3008524126
Contact Person:	Natalia Volosen
	Senior Regulatory Affairs Specialist
Date Prepared:	November 28, 2012
Name of DeviceTrade Name / ProprietaryName:	CONSTRUX Mini® PEEK Ti Spacer System
Common Name:	Intervertebral body fusion device
Product Code:	ODP - cervical intervertebral fusion device with bone graft
Regulatory Classification:	Class II - 21CFR 888.3080 - Intervertebral body fusion device
Review Panel:	Orthopedic Device Panel
Predicate Devices:	K101812 - CONSTRUX Mini PEEK Spacer System,SE 9-27-10
	K100889 - Titan Spine Endoskeleton TC, SE 7-29-10
Reason for 510(k) Submission:	New product offering

Device Description

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Intended Use / Indications for Use

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Summary of the Technological Characteristics of the Device Compared to the Selected
Predicate Devices

Characteristic	Subject Device	Predicates
Device Name	CONSTRUX MiniPEEK Ti SpacerSystem	CONSTRUX Mini PEEKSpacer System(K101812)	Titan SpineEndoskeleton TC(K100889)
Method of Fixation	IBD spacer used withautograft andsupplemental fixation	IBD spacer used withautograft andsupplemental fixation	IBD spacer used withautograft andsupplemental fixation
Implantation	Anterior approach	Anterior approach	Anterior approach
Design	Hollow cage	Hollow cage	Hollow cage
Profile	Parallel and lordotic	Parallel and lordotic	Parallel and lordotic
Material	Polyetheretherketoneand Titanium alloy (Ti-6Al-4V)	Polyetheretherketone)and commercially pureTitanium	Titanium alloy(Ti-6Al-4V)

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Characteristic	Standard / Test/ FDA Guidance
Static and Dynamic Torsion Test	ASTM F2077-11
Static and Dynamic Axial Compression Test	ASTM F2077-11
Static and Dynamic Compression Shear Test	ASTM F2077-11
Subsidence Test	ASTM F2267-04

Performance Data Summary

Mechanical testing for the CONSTRUX Mini PEEK Ti Spacer System was conducted in accordance to ASTM F2077-11 standard for Test Method for Intervertebral Body Fusion Devices and in accordance to ASTM F2267-04 standard for Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device. Test results demonstrated that the new, proposed device is substantially equivalent to predicate device that have the same intended use, similar indications, technological characteristics and principles of operation.

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K121649 Page 3 of 3

Basis of Substantial Equivalence

The new CONSTRUX Mini PEEK Ti Spacer System is substantially equivalent in design, configuration, function, indications for use and materials to the CONSTRUX Mini PEEK Spacer System and Titan Spine Endoskeleton TC device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: November 29, 2012

Orthofix Incorporated % Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K121649

Trade/Device Name: CONSTRUX Mini PEEK Ti Spacer System Regulation Number: 21 CFR 888.3080 Regulatory Class: II Product Code: ODP Dated: October 23, 2012 Received: October 24, 2012

Dear Ms. Volosen:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Natalia Volosen

forth in the quality systems (QS) 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 11 Jou us.it s opes.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Mark N. Melkerson

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

Enclosure

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Indications for Use

510(k) Number (if known): - K121649

Device Name: CONSTRUX Mini® PEEK Ti Spacer System

Indications for Use:

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Prescription Use: X (Part 21 CFR 801 Subpart D) And / Or

Over-The-Counter (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Caroline Rhim -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121649

Page 1 of 1

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.