The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the. treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.

Device Description

The MaxFuse VBR System is a radiolucent, multilevel corpectomy system with VBR devices in a variety of footprint options, height options, and lordotic angle options to accommodate a wide variety of patient anatomy. The MaxFuse VBR devices may be used with bone graft.

AI/ML Overview

This K131724 510(k) premarket notification describes the MaxFuse VBR System, a radiolucent, multilevel corpectomy system used in the thoracolumbar spine. The device is a vertebral body replacement (VBR) system indicated for replacing diseased vertebral bodies due to tumors, achieving anterior decompression, restoring height to collapsed vertebral bodies, and treating thoracic and lumbar spine fractures. It is intended for use with supplemental internal fixation systems.

Here's an analysis of the acceptance criteria and the study conducted for the device:

Acceptance Criteria and Device Performance

This submission focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing rather than clinical study. The acceptance criteria are implicit in meeting the standards of the specified ASTM tests, showing "equivalent results" to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Static and Dynamic Axial Compression Bending (ASTM F 2077)	Substantial equivalence established through side-by-side testing to legally marketed predicate devices, with "equivalent results."
Static Subsidence (ASTM F 2267)	Substantial equivalence established through side-by-side testing to legally marketed predicate devices, with "equivalent results."
Static Expulsion (Draft Z8423Z, Submitted to ASTM F04.25.02.02)	Substantial equivalence established through side-by-side testing to legally marketed predicate devices, with "equivalent results."

No clinical study to demonstrate "device performance" in terms of patient outcomes or biological response is mentioned in this summary. The performance data provided is purely mechanical.

Study Details:

This submission relies on bench testing to demonstrate substantial equivalence, not a clinical study involving human subjects or artificial intelligence. Therefore, many of the requested categories related to clinical trials or AI performance are not applicable.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of human subjects or data records. Rather, it refers to the number of physical devices or constructs tested according to the ASTM standards. The specific number of devices tested for each standard (ASTM F 2077, ASTM F 2267, Draft Z8423Z) is not provided in this summary.
- Data Provenance: The data is from laboratory bench testing of the MaxFuse VBR System and predicate devices. No country of origin is specified for these tests, but they were conducted to U.S. ASTM standards by the manufacturer (Pioneer Surgical Technology, Inc., U.S.). This is a form of prospective testing tailored for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is defined by the objective mechanical measurements dictated by the ASTM testing standards. The standards themselves are developed by expert consensus within ASTM, but no individual experts are cited for establishing ground truth for this specific device's test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was mechanical bench testing against established performance standards, not a diagnostic or clinical assessment requiring adjudication.
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 device is a physical implant, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on objective mechanical measurements according to established ASTM standards (ASTM F 2077, ASTM F 2267, and Draft Z8423Z). These standards define acceptable performance metrics for static and dynamic axial compression bending, static subsidence, and static expulsion.
The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned or implied.

Summary

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K131724

DEC 2 4 2013

・ 510(k) SUMMARY

MaxFuse VBR System

Sponsor:	Manufacturer/(Owner):	Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855
	Phone:Fax:Official Contact:	(906) 225-5602(906) 226-4459Emily M. DownsSarah McIntyre
Device Name:	Date prepared:	December 19, 2013MaxFuse Vertebral Body Replacement (VBR) System
ClassificationName:	Spinal Vertebral Body Replacement Device
Classification:	21 CFR 888.3060 - Product code MQP, Class II
PredicateDevices:	Pioneer Vertebral Spacer (K061151)DePuy Spine Bengal Stackable Cage System (K073649)NuVasive Mesh VBR (K032476)
Description:	The MaxFuse VBR System is a radiolucent, multilevel corpectomy systemwith VBR devices in a variety of footprint options, height options, andlordotic angle options to accommodate a wide variety of patient anatomy.The MaxFuse VBR devices may be used with bone graft.
Intended Use:	The MaxFuse VBR System is indicated for use in the thoracolumbar spine(i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the.treatment of tumors, to achieve anterior decompression of the spinal cord andneural tissues, and to restore the height of a collapsed vertebral body. TheMaxFuse VBR System is also indicated for treating fractures of the thoracicand lumbar spine. The MaxFuse VBR System is designed to restore thebiomechanical integrity of the anterior, middle, and posterior spinal columneven in the absence of fusion for a prolonged period.The MaxFuse VBR System is intended for use with supplemental internalfixation systems cleared for the conditions listed above. The supplementalinternal fixation systems that may be used include the Quantum SpinalFixation System, Streamline TL Spinal Fixation System, and Streamline MISSpinal Fixation System.
Materials:	The MaxFuse VBR System implants are composed of ASTM F 2026Polyetheretherketone (PEEK) with ASTM F 560 tantalum or ASTM F 136titanium alloy radiographic markers.
Performance Data:	Substantial equivalence was established through side-by-side testing tolegally markted predicate devices, including:ASTM F 2077: Static and Dynamic Axial Compression Bending andStatic Torsion ASTM F 2267: Static Subsidence Draft Z8423Z, Submitted to ASTM F04.25.02.02: Static Expulsion
SubstantialEquivalence:	The subject and predicate systems are overall similar in:Intended Usc Basic design: Single-unit VBR with radiographic markers, toothed surface,bone graft containment Materials: PEEK, Titanium alloy, Tantalum Sizes: Footprints, heights, lordosis comparable to predicates Mechanical Performance: equivalent results There are no significant differences between the subject MaxFuse VBRSystem and the predicate devices which would adversely affect the use of theproduct. This submission supports the position that the subject system issubstantially equivalent to previously cleared predicate systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

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

December 24, 2013

Pioneer Surgical Technology, Incorporated Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855

Re: K131724

Trade/Device Name: MaxFuse VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 25, 2013 Received: October 29, 2013

Dear Ms. McIntyre:

We have reviewed vour 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. Sarah McIntyre

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Lori A. Wiggins

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 Statement

510(k) Number (if known): K131724

Device Name: MaxFuse VBR System

Indications:

The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.

Prescription Use V OR (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedia Devices

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.