The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

Device Description

VerteFIT Corpectomy Cages are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include central PEEK cores and titanium-coated PEEK endcaps which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endcaps can be intraoperatively assembled to best fit patient anatomy requirements. Each endcap has a central axial chamber to allow autogenous bone graft or allograft to be packed inside of the spacer. Unidirectional teeth on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. VerteFIT endcaps (superior and inferior) have slots to accommodate VerteBRIDGE anchoring plates.

AI/ML Overview

This document describes the VerteFIT™ Corpectomy Cage System, a vertebral body replacement device. The provided text outlines the device's indications for use and non-clinical performance data, but it does not describe an acceptance criteria table, a study proving device adherence to acceptance criteria, nor does it contain information typically associated with studies of AI/ML devices (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The information provided pertains to the non-clinical performance data which focuses on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI/ML-specific study details.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in a table format. The document implies compliance with standards and guidance documents, such as "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" and various ASTM standards (F2077, F2267, F2129).
Reported Device Performance: The document states that "Mechanical testing was conducted... to demonstrate substantial equivalence to the predicate system(s)." Specific numerical performance results or whether these results "met" an explicit acceptance criterion are not detailed in this summary.

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

Sample Size: Not applicable. The document refers to mechanical testing, not clinical studies involving patient data.
Data Provenance: Not applicable. No patient data or clinical data is mentioned.

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. This is a mechanical device, and "ground truth" as typically understood in AI/ML clinical studies is not relevant. Mechanical testing relies on engineering standards and measurements.

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

Not applicable. No form of adjudication is mentioned as it's not a clinical study involving human interpretation.

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 (spinal implant), not an AI/ML diagnostic or assistive device. No MRMC study or human reader performance is mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering specifications and performance within defined limits of the ASTM standards mentioned.

8. The sample size for the training set

Not applicable. There is no AI/ML component; therefore, no training set.

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

Not applicable. There is no AI/ML component; therefore, no training set ground truth.

Summary of Non-Clinical Performance Data (as provided):

Tests Conducted:
- Static & dynamic compression (ASTM F2077)
- Static & dynamic shear compression (ASTM F2077)
- Static & dynamic torsion (ASTM F2077)
- Subsidence (ASTM F2267)
- Cage and anchor expulsion (F-04.25.05.02)
- Corrosion testing (ASTM F2129)
Purpose: To demonstrate substantial equivalence to predicate device(s) based on mechanical performance.
Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

This document focuses on the regulatory clearance for a physical medical device through a 510(k) pathway, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing and comparison of technical characteristics, rather than extensive clinical efficacy studies or AI/ML performance evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other. The profiles are connected by flowing lines, creating a sense of unity and collaboration.

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

May 16, 2017

LDR Spine USA, Inc. Bradley W. Strasser, RAC Project Manager, Regulatory Affairs 13785 Research Blvd, Suite 200 Austin, Texas 78750

Re: K162133

Trade/Device Name: VerteFIT™ Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: April 14, 2017 Received: April 17, 2017

Dear Mr. Strasser:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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,

Vincent J. Devlin -S

for

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

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

510(k) Number (if known)

K162133 Page 1 of 1

Device Name VerteFITTM Corpectomy Cage System

Indications for Use (Describe)

The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFTT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFTT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color, contrasting with the white background.

510(k) Summary
Owner's Name & Address:	LDR Spine USA13785 Research Blvd. Suite 200Austin, TX 78750
Contact Person:	Bradley W. Strasser, RACProject Manager, Regulatory AffairsPhone: (512) 344-3355Fax: (512) 795-8306Email: brad.strasser@zimmerbiomet.com
Date:	February 15, 2017
Trade Name:	VerteFITTM Corpectomy Cage System
Common Name:	Spinal Vertebral Body Replacement Device
Panel:	Orthopedic
Product Code:	MQP
Classification:	Class II (21 CFR 888.3060)
Predicate Devices:	Primary Predicate:K2M Santorini Corpectomy Cage System (K111294, January 27, 2012)Secondary Predicate:Globus Medical FORTIFYTM I-R (K121107, July 3, 2012)Reference Predicate:LDR Spine ROI-C Titanium (K151934, December 7, 2015)
Device Description	VerteFIT Corpectomy Cages are vertebral body replacementdevices used to provide structural stability in skeletally matureindividuals following corpectomy or vertebrectomy. Thecomponents include central PEEK cores and titanium-coatedPEEK endcaps which are available in a range of sizes and optionsto accommodate the anatomical needs of a wide variety ofpatients. The core and endcaps can be intraoperatively assembledto best fit patient anatomy requirements. Each endcap has a centralaxial chamber to allow autogenous bone graft or allograft to bepacked inside of the spacer. Unidirectional teeth on the superiorand inferior surfaces grip the endplates of the adjacent vertebraeto resist expulsion. VerteFIT endcaps (superior and inferior) haveslots to accommodate VerteBRIDGE anchoring plates.

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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.

Indications for Use:	The VerteFIT TM Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Non-Clinical Performance Data:	Mechanical testing was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" to demonstrate substantial equivalence to the predicate system(s). The following testing was done: Static & dynamic compression (ASTM F2077)Static & dynamic shear compression (ASTM F2077)Static & dynamic torsion (ASTM F2077)Subsidence (ASTM F2267)Cage and anchor expulsion (F-04.25.05.02)Corrosion testing (ASTM F2129)
Clinical Performance Data:	Clinical testing was not required to demonstrate substantial equivalence.
Basis of Substantial Equivalence:	The VerteFIT Corpectomy Cage System implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s).

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.