The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Device Description

The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion.

The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device.

The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,

The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances.

The system does not contain software/firmware.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Calix® Lumbar Spinal Implant System), which is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device. This type of submission primarily relies on non-clinical performance data (mechanical and material testing) to demonstrate that the new device performs as well as or better than the predicate, especially when modifications are made.

The document does not describe an AI/ML-driven device or diagnostic tool that would require a study involving human readers, ground truth establishment through expert consensus (radiologists), or MRMC/standalone performance metrics typical of AI models. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

The acceptance criteria and proof of performance for this particular device (a spinal implant) are based on mechanical and material testing as per established ASTM standards and FDA recommendations for intervertebral body fusion devices.

Here's a breakdown of the relevant information from the provided text, addressing the points where applicable and noting when information is not present or relevant:

Acceptance Criteria and Device Performance (for a spinal implant)

The acceptance criteria for this medical device are primarily based on demonstrating mechanical equivalence and safety to predicate devices, adhering to recognized standards. The "performance" here refers to the physical and functional integrity of the implant, not diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Area	Specific Tests / Requirements	Reported Device Performance
Mechanical Performance	- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices (Dynamic Compression Shear, Static Compression, Static Compression-Shear)	The tests demonstrate that the addition of the medical grade commercially pure titanium plasma coating does not present a new worst case, and does not impact the performance of the implants.
	- Expulsion testing as recommended by FDA	Performance is equivalent to or better than the predicate device.
Subsidence	- ASTM F2267: Test Methods for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression	(Not explicitly stated in detail for the new modifications, but implied to be acceptable based on the predicate's performance and no new worst case.)
Material Characterization	- ASTM F1877: Standard Practice for Characterization of Particles (for titanium plasma coating)	The characterization confirms the material properties and safety of the new coating.
Biocompatibility	(Implied by use of PEEK-Optima™ LT1 per ASTM F2026 and CP Ti per ASTM F1580, which are well-established biocompatible materials for implants.)	(Not explicitly detailed in the performance section, but these are FDA-recognized materials for implants.)
Compatibility with Bone Grafts	- Expansion of Indications for Use to include allograft comprised of cancellous and/or corticocancellous bone graft.	The expansion "does not impact the mechanical performance" and "does not introduce new risks."

Detailed Information as per Request (with applicability notes):

A table of acceptance criteria and the reported device performance
- See table above. The acceptance criteria are largely adherence to specified ASTM standards and demonstrating that the modifications (titanium coating, allograft use) do not negatively impact performance compared to the predicate.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. For this type of device (spinal implant), "sample size" refers to the number of physical devices or material samples tested in a lab, not a population of patients or images. The document does not specify the exact number of implants tested for each mechanical test, which is common for 510(k) summaries where the methodology typically follows established engineering test standards.
- Data Provenance: The data originates from the manufacturer's (X-spine Systems, Inc.) internal testing, conducted in their facilities or contracted labs. This is not clinical data, so terms like "retrospective" or "prospective" are not applicable.
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)
- N/A. "Ground truth" in the context of this spinal implant device is established through physical mechanical testing and material characterization according to validated engineering standards (ASTM). It does not involve expert clinical assessment or image interpretation for establishing a "ground truth" diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-reader studies (e.g., in diagnostic imaging). This regulatory submission is for a physical implant, not a diagnostic AI device.
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
- N/A. An MRMC study is designed to evaluate the performance of diagnostic devices, particularly AI-assisted ones, by comparing human reader performance with and without AI assistance. This submission is for an orthopedic implant and does not involve AI or human readers for diagnosis.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This refers to the standalone performance of an AI algorithm. The device is a physical implant, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering standards and established physical properties. For example, the acceptable load-bearing capacity, expulsion resistance, and material characteristics determined by industry-standard mechanical testing are the "ground truth" for its functional performance.
- For the Indications for Use, the "ground truth" for degenerative disc disease (DDD) is defined clinically: "back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies." This is a clinical definition for patient selection, not a ground truth for testing the device itself.
The sample size for the training set
- N/A. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established
- N/A. No training set exists for this device.

Summary of Acceptance and Performance:

The Calix® Lumbar Spinal Implant System's acceptance and demonstrated performance hinge on its ability to meet or exceed the performance characteristics of its predicate device, the Calix® Lumbar Spinal Implant System (K131350), and other reference devices. The key elements of its "proof" are:

Mechanical Testing: Demonstrating compliance with ASTM F2077 (for static/dynamic compression/shear) and ASTM F2267 (for subsidence) and FDA-recommended expulsion testing. The critical finding is that the new titanium plasma coating "does not present a new worst case, and does not impact the performance of the implants."
Material Characterization: Showing the properties of the new CP Ti plasma coating via ASTM F1877.
Indications for Use Expansion: Justifying that the addition of allograft use "does not impact the mechanical performance" and "does not introduce new risks," citing that allograft has been cleared for many other spinal implants.
Substantial Equivalence: Ultimately, the study (mechanical and material testing) served to prove that the modified device is substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness, despite the added coating and expanded graft options.

Summary

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Public Health Service

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

September 29, 2017

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X-spine Systems, Inc. Charlene Brumbaugh Regulatory Affairs Manager 452 Alexandersville Rd. Miamisburg, Ohio 45342

Re: K170119

Trade/Device Name: Calix® Lumbar Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 29, 2017 Received: August 30, 2017

Dear Ms. Brumbaugh:

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

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related 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.

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 (DICE) 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 (DICE) 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,

Katherine D. Kavlock -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

510(k) Number (if known)

K170119

Device Name

Calix® Lumbar Spinal Implant System

Indications for Use (Describe)

The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

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)	☐

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510(K) SUMMARY (21 CFR 807.92)

Calix® Lumbar Spinal Implant System

Date Prepared: August 29, 2017

I. SUBMITTER/MANUFACTURER:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342Telephone (937) 847-8400FAX (937) 847-8410
	Establishment Registration Number: 3005031160

Official Contact:	Charlene BrumbaughRegulatory Affairs ManagerEmail: cbrumbaugh@X-spine.comTelephone (937) 847-8400, ext. 2192
II. OWNER/OPERATOR:	Xtant Medical Inc.604 Cruiser LaneBelgrade, MT 59714
Owner/Operator Number:	10028385
Official Correspondent:	Stephen Smith, Vice PresidentRegulatory Assurance/ Quality AssuranceXtant Medical, Inc.Telephone (406) 388-0480
III. DEVICE
Trade/Proprietary Name:	Calix® Lumbar Spinal Implant System
Device Common Name:	Intervertebral Body Fusion Device
Regulation Number:	21 CFR §888.3080
Product Code:	MAX -- Intervertebral body fusion device

Regulatory Class: Review Panel:

with Bone Graft, Lumbar Class II with Special Controls Orthopedic

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IV. PREDICATE DEVICES

Primary: X-spine, Inc.: Calix® Lumbar Spinal Implant System (K131350) ●
Additional: ●
- o Biomet: Zyston Straight Interbody Spacer System (K112014)
- NuVasive: CoRoent Ti-C System (K160916) o

REFERENCE DEVICES V.

NuVasive Lumbar Interbody Implants (K161230)
Alphatec Spine: Battalion Universal Spacer System (K160958) ●
Globus Medical: Independence MIS Spacers (K160597) ●
NuVasive® Lumbar Interbody Implants (K153782)

Additional Reference Device:

X-spine Calix™ Cervical PC Spinal Implant System (K112036) is included because it is an intervertebral body fusion device that is CP-Ti plasma coated PEEK, provided non-sterile, and manufactured using the same materials and same processes as the proposed devices in this submission.

INDICATIONS FOR USE VI.

VII. DEVICE DESCRIPTION

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The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,

The system does not contain software/firmware.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES VIII.

The technological principle for both the subject and primary predicate device is fixation at one or two contiguous levels (L2—S1 inclusive) in the lumbosacral spine for skeletally mature patients with degenerative disc disease.

Primary Predicate Device:

The subject device, Calix® Lumbar Spinal Implant System and the primary predicate device, Calix® Lumbar Spinal Implant System (K131350) are based on the following technological elements:

o Same FDA Product Code: MAX -- Intervertebral Body Fusion Device, Lumbar with Bone Graft.
Same implant materials: Invibio PEEK-Optima™ LT1 with tantalum markers. o
Equivalent Indications for Use. O
Multiple lengths, widths, and heights to account for variations in patient O anatomy. Same range of sizes of devices offered.
Same anatomical region: one or two contiguous levels (L2-S1 inclusive). O
Same surgical approaches: Anterior, posterior, and/or transforaminal. O
Mechanical performance. O

The subject device has two additional technological elements:

Expansion of the Indications for Use to include the use of allograft comprised O of cancellous and/or corticocancellous bone graft.
Addition of medical-grade titanium plasma coating (CP Ti) per ASTM F1580 o on the superior and inferior surfaces of the implants.

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Additional Predicate Devices:

. NuVasive CoRoent Ti-C System (K160916) has the same technological elements that are listed above for the subject device and the primary predicate device. It also has the two additional technological elements that are listed referenced above, allograft and titanium plasma coating.
Biomet Zyston Straight Interbody Spacer System (K112014) has similar technological elements to the Calix® Lumbar Spinal Implant System. It is included in this 510k for comparison of performance data.

Reference Devices:

NuVasive Lumbar Interbody Implants (K161230)
Alphatec Spine: Battalion Universal Spacer System (K160958)
Globus Medical: Independence MIS Spacers (K160597)
. NuVasive® Lumbar Interbody Implants (K153782)

The above reference devices have been 510k cleared with the same or similar technological elements as included in the Calix subject device:

Indications for Use including allograft along with autograft
. Anatomical region of one or two contiguous levels (L2—S1 inclusive)
MAX product code
Implant materials of PEEK and/or Titanium Alloy
. Coated with medical grade commercially pure titanium (CP Ti) plasma coating

Additional Reference Device:

. X-spine Calix™ Cervical PC Spinal Implant System (K112036) is included because it is an intervertebral body fusion device that is CP-Ti plasma coated PEEK, and manufactured using the same materials and same processes as the proposed devices in this submission.

IX. PERFORMANCE DATA

The predicate system, Calix® Lumbar Spinal Implant System (K131350), was subjected to the following mechanical testing as recommended in the special controls guidance document, "Class II Special Controls Guidance: Intervertebral Body Fusion Device".

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Therefore most of those tests were not repeated, since the size offerings and footprints of the coated implants are the same as the uncoated:

ASTM F2077- Test Methods for Intervertebral Body Fusion Devices
. Expulsion testing as recommended by FDA
ASTM F2267-04 Test Methods for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

For the proposed Calix® Lumbar Spinal Implant System (with titanium plasma coated implants) testing was performed in order to demonstrate that the new titanium plasma coated implants perform as well as or better than the predicate device, Calix® Lumbar Spinal Implant System (K131350). The tests that were performed are:

. ASTM F2077 Test Methods for Intervertebral Body Fusion Devices: Dynamic Compression Shear
Expulsion Testing as recommended by the FDA
ASTM F1877 Standard Practice for Characterization of Particles.

The results of the testing demonstrate that the addition of the medical grade commercially pure titanium plasma coating does not present a new worst case, and does not impact the performance of the implants.

The proposed expansion of the indications for use, i.e. the addition of the use of allograft, does not impact the mechanical performance of the Calix® Lumbar Titanium Plasma Coated implants, and does not introduce new risks. Allograft has been 510k cleared for a large number of spinal implants that formerly were cleared only for autograft.

X. CONCLUSION

The subject device, Calix® Lumbar Spinal Implant System, has been modified to expand the Indications for Use, and to add medical grade commercially pure titanium (CP Ti) plasma coated versions of the original Calix® Lumbar implants. Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Calix® Lumbar Spinal Implant System demonstrates substantial equivalence to legally marketed predicate devices.

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.