The Curiteva Lumbar Interbody Fusion is 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 back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.

Device Description

The Curiteva Lumbar Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate surgical approach, and the individual pathology and anatomical conditions of the patient.

The implants are generally rectangle-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

The Curiteva Lumbar Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information for the Curiteva Lumbar Interbody Fusion System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria and performance data are entirely focused on mechanical testing, as this is a 510(k) submission for an intervertebral body fusion device, which typically relies on demonstrating substantial equivalence to predicates through physical and mechanical properties.

Acceptance Criteria (General for Intervertebral Body Fusion Devices)	Reported Device Performance (Curiteva Lumbar Interbody Fusion System)
Sufficient strength for intended use (e.g., maintaining spinal stability).	"The strength and performance... is sufficient for its intended use."
Demonstrated performance under static axial compression as per ASTM F2077.	Mechanically tested for static axial compression per ASTM F2077.
Demonstrated performance under dynamic axial compression as per ASTM F2077.	Mechanically tested for dynamic axial compression per ASTM F2077.
Demonstrated performance under static compression-shear as per ASTM F2077.	Mechanically tested for static compression-shear per ASTM F2077.
Demonstrated performance under dynamic compression-shear as per ASTM F2077.	Mechanically tested for dynamic compression-shear per ASTM F2077.
Resistance to subsidence as per ASTM F2267.	Mechanically tested for subsidence per ASTM F2267.
Resistance to expulsion.	Mechanically tested for expulsion.
Characterization of wear debris as per ASTM F1877.	Mechanically tested for wear debris characterization per ASTM F1877.
Substantial equivalence to legally marketed predicate devices.	"is substantially equivalent to legally marketed predicate devices."

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

This document describes non-clinical mechanical testing of the device prototypes. Therefore:

Sample size used for the test set: Not explicitly stated numerically for each test, but it would involve multiple samples of the device undergoing the specified mechanical tests. For medical device mechanical testing, typically a sufficient number of samples (e.g., n=5 or more per test condition) are used to ensure statistical validity and representativeness, but no specific numbers are given here.
Data provenance: As this is non-clinical testing, the data provenance is from laboratory testing performed by the manufacturer (Curiteva, LLC) or a contracted testing facility. It is not patient-derived data (e.g., no country of origin or retrospective/prospective clinical study applies here).

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

This question is not applicable to the data presented. Ground truth and expert consensus are concepts relevant to clinical studies involving human interpretation or pathology. The study described here is purely mechanical testing of a physical device. The "ground truth" for these tests are the established ASTM standards and the physics of material behavior.

4. Adjudication Method for the Test Set

This question is not applicable as there is no "adjudication" in the context of mechanical testing. The results are quantitative measurements against predefined standards (ASTM F2077, F2267, F1877).

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

No, an MRMC comparative effectiveness study was not done. This type of study evaluates human reader performance, typically with medical images, both with and without AI assistance. The provided document describes mechanical testing of a physical implant.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is derived from established engineering and material science standards (ASTM) and the objective measurements obtained from laboratory mechanical testing. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical testing of a physical device. Training sets are relevant to machine learning algorithms.

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

This question is not applicable for the same reason as above; there is no training set mentioned or implied in this document.

Summary

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December 20, 2018

Curiteva, LLC Eric Linder Chief Operating Officer 25127 Will McComb Drive, Suite 100 Tanner, Alabama 35671

Re: K181589

Trade/Device Name: Curiteva Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 27, 2018 Received: November 29, 2018

Dear Eric Linder:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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) K181589

Device Name

Curiteva Lumbar Interbody Fusion System

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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K181589 Page 1 of 2

510(k) Summary

A. Submitter Information

Submitter:	Curiteva, LLC25127 Will McComb DriveTanner, AL 35671Phone: (256) 213-1057Fax: (256) 213-1058
Contact Person:	Eric Linderregulatory@curiteva.com
Date Prepared:	November 27, 2018

B. Device Information

Trade Name:	Curiteva Lumbar Interbody Fusion System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Device Classification:	Class II (per 21 CFR 888.3080)
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices
Predicate Device(s):	Primary: Interbody Innovations, LLP Zeus Small Cervical Cageand Large, Extra Large, Curved and Straight Lumbar Cages –K081614Additional: Meditech Spine, LLC Talos Lumbar (HA) PEEK IBFDevices – K170395Additional: Tyber Medical, LLC Interbody System – ACIF, ALIF,PLIF, TLIF, and DLIF – K130573Additional: Titan Spine, LLC Endoskeleton® System(Endoskeleton® TA Interbody Fusion Device, Endoskeleton®TAS Interbody Fusion Device, Endoskeleton® TO InterbodyFusion Device, Endoskeleton® TT Interbody Fusion Device,Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TLInterbody Fusion Device, Endoskeleton® TA Vertebral BodyReplacement) – K141953

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C. Device Description

D. Indications for Use

The Curiteva Lumbar Interbody Fusion System is 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 back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.

E. Technological Characteristics

As was established in this submission, the subject Curiteva Lumbar Interbody Fusion is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

F. Performance Data

The Curiteva Lumbar Interbody Fusion System was mechanically tested in the following test modes: static and dynamic axial compression per ASTM F2077, static and dynamic compressionshear per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877.

The results of this non-clinical testing show that the strength and performance of the Curiteva Lumbar Interbody Fusion System is sufficient for its intended use and is substantially equivalent 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.