The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft.

GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach.

The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach.

The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.

Device Description

The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF.

The ASTRAEUS anterior lumbar interbody fusion (ALIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The ASTRAEUS ALIF devices are to be implanted via an anterior approach.

The PROMETHEUS posterior lumbar interbody fusion (PLIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The PROMETHEUS PLIF devices are to be implanted via a posterior approach.

The THEMIS transforaminal posterior lumbar interbody fusion (TPLIF) implants are interbody fusion devices intended for use an aid in spinal fixation and provided structural stability in skeletally mature patients. THE THEMIS TPLIF devices are to be implanted via a transforaminal or posterior approach.

The GAIA Lumbar Interbody Fusion Device (LIFD) Family implants are manufactured additively from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are offered in a variety of standard sizes (width, length, height, lordotic angle) designed to adapt to many different patient anatomy. Each interbody device has an axial graft window to allow bone grafting material of autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to be placed inside the interbody. Various interbody window lattices are provided to adapt to various bone graft placement methods. High friction surfaces with protrusions on superior and inferior of the interbody fusion device grip the end plates of adjacent vertebrae to resist expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.

AI/ML Overview

This document describes the GAIA Lumbar Interbody Fusion Device (LIFD) Family, which includes the ASTRAEUS ALIF, PROMETHEUS PLIF, and THEMIS TPLIF devices. These devices are intended for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, and may also be used in patients with up to Grade 1 spondylolisthesis or retrolisthesis, or degenerative scoliosis. They are designed to be used with autogenous and/or allograft bone graft and supplemental spinal fixation systems.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GAIA Lumbar Interbody Fusion Device (LIFD) Family are based on mechanical strength testing to ensure suitability for its intended use and substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated in the provided text, the reported performance indicates the device meets these criteria by being "sufficient for its intended use and substantially equivalent to legally marketed predicate devices."

Acceptance Criteria Category	Specific Test Standard	Reported Device Performance
Mechanical Strength	Static Axial Compression	Sufficient for intended use; substantially equivalent to predicate devices
	Dynamic Axial Compression	Sufficient for intended use; substantially equivalent to predicate devices
	Static Compression Shear	Sufficient for intended use; substantially equivalent to predicate devices
	Dynamic Compression Shear	Sufficient for intended use; substantially equivalent to predicate devices
	Subsidence (per ASTM F2267-04 (2018))	Sufficient for intended use; substantially equivalent to predicate devices

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

The document does not specify the exact sample sizes used for each of the mechanical tests (static and dynamic axial compression, static and dynamic compression shear, and subsidence). The data provenance is derived from "non-clinical testing" conducted on the GAIA Lumbar Interbody Fusion Device (LIFD) Family. Further details regarding the testing facility or specific country of origin are not provided, nor is whether the data is retrospective or prospective, though non-clinical testing is inherently prospective for device clearance.

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

This section is not applicable. The GAIA Lumbar Interbody Fusion Device (LIFD) Family is a physical medical device, and its performance evaluation for FDA clearance (510(k)) relies on non-clinical mechanical testing results, not on expert-established ground truth related to diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This section is not applicable, as the evaluation method is based on objective mechanical testing against defined standards, not on subjective assessment or adjudication by experts.

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

No, an MRMC comparative effectiveness study was not done. The provided information pertains to the clearance of a physical medical device (interbody fusion device) based on mechanical performance, not a diagnostic or AI-assisted system that would involve human readers.

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

This section is not applicable. The device in question is a physical interbody fusion device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the specified ASTM international standards (ASTM F2077-18 for axial compression and compression shear, and ASTM F2267-04 (2018) for subsidence). These standards define acceptable mechanical properties and performance criteria for intervertebral body fusion devices. The device's performance is evaluated against these engineering standards.

8. The Sample Size for the Training Set

This section is not applicable. The GAIA Lumbar Interbody Fusion Device (LIFD) Family is a physical medical device. There is no "training set" in the context of mechanical testing for a physical device, unlike in the development of AI or diagnostic algorithms.

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

This section is not applicable, as there is no training set for a physical medical device.

Summary

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October 8, 2020

PrinterPrezz % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K201939

Trade/Device Name: GAIA Lumbar Interbody Fusion Device (LIFD) Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 10, 2020 Received: July 13, 2020

Dear Mr. Wright:

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 medical devices and radiation-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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

Indications for Use

510(k) Number (if known)

K201939 Device Name

GAIA Lumbar Interbody Fusion Device (LIFD) Family

Indications for Use (Describe)

GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

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

□ Over-The-Counter Use (21 CFR 801 Subpart C) ∑ Prescription Use (Part 21 CFR 801 Subpart D)

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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services

Food and Drug Administration

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Office of Chief Information Officer

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

FORM FDA 3881 (7/17)

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5.510(K) SUMMARY

Submitter's Name:	PrinterPrezz
Submitter's Address:	4110 Clipper Ct.Fremont, CA 94538
Submitter's Telephone:	510-225-8412
Contact Person:	Nathan Wright MSEmpirical Consulting719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	10-Jul-2020
Trade or Proprietary Name:	GAIA Lumbar Interbody Fusion Device (LIFD) Family
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF.

PrinterPrezz GAIA Lumbar Interbody Fusion Device (LIFD) Family

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expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.

INDICATIONS FOR USE

The ASTRAEUS anterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The ASTRAEUS ALIF cage is to be implanted via an anterior approach.

The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The PROMETHEUS PLIF cage is to be implanted via a posterior approach.

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The THEMIS Transforaminal posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

GAIA devices, including the THEMIS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

o Indications for Use
O Materials of manufacture
Structural support mechanism 0
Sizes

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K170676	HD Lumbar Interbody System	HD LifeSciences LLC	Primary
K172816	TiGer Shark™ System	Choice Spine, LP	Additional
K162496	Foundation F3 Interbody	CoreLink, LLC	Additional
K143258	PLIF STS, TLIF STS, and OLIFSTS	4WEB, Inc.	Additional
K180556	Foundation 3D Anterior LumbarSystem	CoreLink, LLC	Additional
K190483	SPIRA Open Matrix ALIF andLLIF	Camber SpineTechnologies	Additional
K111354/K131612	AnyPlus® PEEK Lumbar FusionCage	GS Medical Co, Ltd.	Additional

Table 5-1 Predicate Devices

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PERFORMANCE DATA

The GAIA Lumbar Interbody Fusion Device (LIFD) Family has been tested in the following test modes:

o Static and dynamic axial compression per ASTM F2077-18
Static and dynamic compression shear per ASTM F2077-18 0
o Subsidence per ASTM F2267-04 (2018)

The results of this non-clinical testing show that the strength of the GAIA Lumbar Interbody Fusion Device (LIFD) Family is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the GAIA Lumbar Interbody Fusion Device (LIFD) Family is substantially equivalent to the predicate device.

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.