SPIRA®-P Posterior Lumbar Spacers are lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA®-T Oblique Posterior Lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

Device Description

SPIRA Posterior Lumbar Spacers (SPIRA-P Open Matrix PLIF, SPIRA-T Oblique Open Matrix TLIF) are lumbar interbody fusion devices used to provide structural stability following discectomy. SPIRA Posterior Lumbar Spacers have different shapes to accommodate posterior and transforaminal approaches.

AI/ML Overview

The provided text describes a 510(k) premarket notification for SPIRA®-T Oblique Posterior Lumbar Spacers and SPIRA®-P Posterior Lumbar Spacers. This is a submission to demonstrate substantial equivalence to previously cleared devices, not a study evaluating an AI/ML-based device. Therefore, the detailed information typically requested for AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document discusses mechanical performance testing of intervertebral body fusion devices, not the diagnostic performance of an imaging AI.

Here's the information that can be extracted regarding the acceptance criteria and proof of mechanical performance for this physical device:

Acceptance Criteria and Device Performance (Mechanical Testing)

Acceptance Criteria	Reported Device Performance
Defined by predicate device performance (specifically Globus HEDRON Lumbar Spacers (K191391) and other referenced predicates).	The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Specific tests: Static compression-static compression-shear, dynamic compression, dynamic compression-shear, and subsidence per ASTM F2077-18 and F2267-04.	Testing performed indicated that the SPIRA Posterior Lumbar Spacers are as mechanically sound as predicate devices.

The study described in this document is a series of mechanical performance tests, not a clinical study involving human readers or an AI algorithm.

Therefore, most of the specific questions regarding AI/ML device performance metrics (sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not relevant or answerable from the provided text, as the device is a physical medical implant, not a software device.

Summary

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June 15, 2021

Camber Spine Technologies, LLC Donald Guthner Manager, Regulatory Affairs 501 Allendale Road King of Prussia, Pennsylvania 19604

Re: K210595

Trade/Device Name: SPIRA®-T Oblique Posterior Lumbar Spacers, SPIRA®-P Posterior Lumbar Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 16, 2021 Received: March 17, 2021

Dear Donald Guthner:

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.

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

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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 L. 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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Indications for Use

510(k) Number (if known)

K210595

Device Name SPIRA®-P Posterior Lumbar Spacers

Indications for Use (Describe)

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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Indications for Use

510(k) Number (if known)

K210595

Device Name SPIRA®-T Oblique Posterior Lumbar Spacers

Indications for Use (Describe)

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)

| * | 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:	SPIRA®-T Oblique Posterior Lumbar SpacerSPIRA®-P Posterior Lumbar Spacer
Manufacturer:	Camber Spine Technologies501 Allendale RoadKing of Prussia, PA 19406
Contact:	Mr. Donald W. GuthnerManager of Regulatory AffairsCamber Spine Technologies, LLC501 Allendale RoadKing of Prussia, PA 19406Office: 484.427.7060Fax: 484.263.2930dguthner@cambermedtech.com
Date Prepared:	March 16, 2021
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Code:	MAX
Primary Predicate:Reference Predicate(s):	Globus HEDRON Lumbar Spacers (K191391)4WEB Posterior Spine Truss System (PSTS) Interbody Fusion Device(K171351)Camber Spine Technologies Ti-Diagon Oblique TLIF (K172064)Camber Spine Technologies SPIRA-A Open Matrix ALIF (K190483)

Indications For Use:

SPIRA® P Posterior Lumbar Spacers are lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA®-T Oblique Posterior Lumbar Spacers are lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with

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autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

Device Description:

Predicate Device:

The subject SPIRA Posterior Lumbar Spacers is substantially equivalent to primary predicate, Globus HEDRON Lumbar Spacers (K191391). Additional predicates were referenced with regards to design inputs, materials, and manufacturing: the 4WEB Posterior Spine Truss System (PSTS) Interbody Fusion Device (K171351), Camber Spine Technologies Ti-Diagon Oblique TLIF (K172064), and Camber Spine Technologies SPIRA-A Open Matrix ALIF (K190483).

Performance Testing Summary:

Testing performed indicate that the SPIRA Posterior Lumbar Spacers are as mechanically sound as predicate devices. Testing included static compression-static compression-shear, dynamic compression, dynamic compression-shear, and subsidence per ASTM F2077-18 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.

Substantial Equivalence:

The subject SPIRA Posterior Lumbar Spacers device was demonstrated to be substantially equivalent to primary predicate, Globus HEDRON Lumbar Spacers (K191391). Additional predicates were referenced with regards to design inputs, materials, and manufacturing: the 4WEB Posterior Spine Truss System (PSTS) Interbody Fusion Device (K171351), Camber Spine Technologies Ti-Diagon Oblique TLIF (K172064), and Camber Spine Technologies SPIRA-A Open Matrix ALIF (K190483).

Conclusion:

Camber Spine Technologies has provided sufficient information to demonstrate the SPIRA Posterior Lumbar Spacers are substantially equivalent to primary predicate, the Globus HEDRON Lumbar Spacers (K191391) and additional predicates, the 4WEB Posterior Spine Truss System (PSTS) Interbody Fusion Device (K171351), Camber Spine Technologies Ti-Diagon Oblique TLIF (K172064), and Camber Spine Technologies SPIRA-A Open Matrix ALIF (K190483) with respect to indications, design, materials, function, manufacturing, and/or 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.