The neoWave LS Porous Titanium Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). neoWave LS Porous Titanium Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The neoWave LS Porous Titanium Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The neoWave C Porous Titanium Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

When used as a Cervical Interbody Fusion device, Ti3D Cervical is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Device Description

Xenix Medical neoWave LS Lumbar Straight Cages are intervertebral body fusion devices intended for use in the lumbar spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 6-17mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Xenix Medical neoWave C Cervical Cage is intervertebral body fusion device intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Xenix Medical Ti3D Cervical Cages are intervertebral body fusion devices intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

AI/ML Overview

This document describes the premarket notification (510(k)) for new Wave LS Lumbar Straight, newWave C Cervical, and Ti3D Cervical intervertebral body fusion devices. This submission aims to add a nanotechnology claim and a change in the additive manufacturing (AM) supplier.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility/Surface Characteristics	In vitro evaluations and imaging studies (for nanotechnology claim)	Demonstrate production of micro and nano surface roughness (1-100 nanometers) and exhibit specific osteogenic differentiation.	"The in vitro study results demonstrated the modified NANOACTIV nanosurface as supporting differentiation of mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix as compared to non-treated surfaces."
Mechanical Performance	ASTM F2077	Maintain mechanical integrity and performance comparable to predicate devices.	"confirmatory mechanical testing per ASTM F2077 was performed to support the change in AM supplier. ASTM F2077 testing was performed on the cervical (dynamic axial compression, dynamic torsion) and lumbar (dynamic axial compression, dynamic compression shear) versions of the devices."

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

The document does not explicitly state the sample size for the "test set" in terms of patient data. The performance testing described focuses on in vitro and mechanical evaluations.

For in vitro evaluations and imaging studies: The sample size isn't specified, but it refers to "human mesenchymal stem cells in vitro." The provenance is in vitro (laboratory setting).
For mechanical testing (ASTM F2077): The number of devices tested isn't specified, but it was performed on "cervical (dynamic axial compression, dynamic torsion) and lumbar (dynamic axial compression, dynamic compression shear) versions of the devices." This is laboratory-based testing, not human data.

The data provenance is limited to laboratory studies (in vitro and mechanical testing) and does not involve human subjects or clinical data in the context of this 510(k) submission. Therefore, it is retrospective in the sense that no new clinical patient data was collected for this specific submission for performance evaluation.

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

This information is not provided in the document. The performance testing described (in vitro and mechanical) does not involve expert review or establishment of "ground truth" in the clinical sense with patient data. The "ground truth" for the in vitro study would be the observable cellular and biochemical responses, which are quantitative and not subject to expert consensus in the same way clinical diagnoses would be.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-read test set or clinical outcome data that would require an adjudication method. The evaluations are objective laboratory tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes laboratory-based in vitro and mechanical testing, not clinical studies involving human readers or patient cases. Therefore, no effect size of human readers improving with or without AI assistance is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. The devices are intervertebral body fusion cages, which are physical implants, not AI algorithms. The "nanotechnology claim" refers to the surface features of the physical implant, not a software algorithm.

7. The Type of Ground Truth Used

For Biocompatibility/Surface Characteristics (in vitro studies): The ground truth is established by observable cellular and biochemical responses (e.g., mineralization in human mesenchymal stem cells) as measured and quantified in a laboratory setting.
For Mechanical Performance (ASTM F2077): The ground truth is defined by objective measurements of mechanical properties according to the ASTM F2077 standard.

8. The Sample Size for the Training Set

This information is not applicable. The described device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by prior research and engineering principles, but not a dataset used to train an algorithm.

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

This information is not applicable as there is no training set for an AI algorithm.

Summary

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September 1, 2023

HT Medical d.b.a. Xenix Medical % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA 803 7th Street NW, 3rd Floor Washington, District of Columbia 20001

Re: K222988

Trade/Device Name: new Wave LS Lumbar Straight, newWave C Cervical, and Ti3D Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: August 2, 2023 Received: August 2, 2023

Dear Justin Eggleton:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222988

Device Name

neoWave LS Lumbar Straight

Indications for Use (Describe)

The neoWave LS Porous Titanium Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). neoWave LS Porous Titanium Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The neoWave LS Porous Titanium Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222988

Device Name neoWave C Cervical

Indications for Use (Describe)

The neo Wave C Porous Titanium Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222988

Device Name

Ti3D Cervical

Indications for Use (Describe)

When used as a Cervical Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Device Trade Name:	neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3DCervical
Manufacturer:	HT Medical, LLC d.b.a. Xenix Medical111 W Jefferson St., Suite 100Orlando, FL 32801
Contact:	Teresa CherryVice President of Quality Assurance and Regulatory AffairsXenix Medical
Prepared by:	Mr. Justin EggletonVice President, Head of Musculoskeletal Regulatory AffairsMCRA, LLC803 7th Street NW, 3rd FloorWashington, DC 20001jeggleton@mcra.com
Date Prepared:	August 31, 2023
Classifications:	21 CFR §888.3080; Intervertebral body fusion device
Class:	II
Product Codes:	ODP, MAX

Purpose of the Submission:

The purpose of the subject 510(k) was to add a nanotechnology claim in alignment with the FDA 's Guidance on Nanotechnology and to request an additional/change in AM manufacturer.

Indications for Use:

neoWave LS Lumbar Straight

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treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

neoWave C Cervical

Ti3D Cervical

Device Description:

neoWave LS Lumbar Straight

Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

neoWave C Cervical

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ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Ti3D Cervical

Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Predicate Devices:

Device Name(s)	Manufacturer	K-Number
TiWAVE-L Porous Titanium Lumbar Cage (TiWAVE-L)	Kalitec Direct, LLC	K182210
TiWAVE-C™ Porous Titanium Cervical Cage (TiWAVE-C)	Kalitec Direct, LLC	K180401
Ti3D Cervical (NeoFuse Cervical)	HT Medical, LLC	K170318

Performance Testing Summary:

In consideration of the FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, in vitro evaluations and imaging studies were performed to assess that the deliberately modified NANOACTIV surface produces micro and nano surface roughness ranging in size between 1-100 nanometers, which exhibit specific osteogenic differentiation. The in vitro study results demonstrated the modified NANOACTIV nanosurface as supporting differentiation of mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix as compared to a non-treated surfaces.

In addition to the testing described above, confirmatory mechanical testing per ASTM F2077 was performed to support the change in AM supplier. ASTM F2077 testing was performed on the cervical (dynamic axial compression, dynamic torsion) and lumbar (dynamic axial compression, dynamic compression shear) versions of the devices.

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Substantial Equivalence:

The subject device was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, materials, function, manufacturing, and performance.

Conclusion:

The Xenix Medical Interbody Cage devices are substantially equivalent to the cited predicate devices with respect to indications for use, design, function, materials, and performance.

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.