The ProLift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Description

The ProLift® Pivot Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) and Cobalt Chrome (CO- 26Cr-6MO) as described by ASTM F136and ASTM F1537. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The ProLift® Pivot Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient.

The ProLift implants are fabricated and manufactured from titanium alloy (Ti-6Al-. 4V ELI) as described by ASTM F136.
. The ProLift Pivot-U implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537.
The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All ProLift Pivot implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Pivot Expandable Spacer System components with components from any other system or manufacturer.

AI/ML Overview

This document pertains to the clearance of a medical device, the ProLift Pivot Expandable Spacer System, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for AI models is not applicable to this submission.

The document discusses the substantial equivalence of the ProLift Pivot Expandable Spacer System to predicate devices based on design, materials, indications for use, sizing, and mechanical performance.

Here's a breakdown of the relevant information provided:

A table of acceptance criteria and the reported device performance:
The document does not present a formal table of acceptance criteria with reported performance values in the context of an AI/ML study. Instead, it states that "Performance Data: Static compression shear, Static Axial Compression, Dynamic Compression Shear and Dynamic Axial Compression according to ASTM F2077 was presented to demonstrate the substantial equivalency of the Life Spine ProLift Expandable Spacer System (K190488)." This implies that the acceptance criteria are adherence to the mechanical testing standards outlined in ASTM F2077, and the device performance met these standards to demonstrate substantial equivalence to the predicate device (K190488).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a medical device clearance based on mechanical testing, not an AI/ML study involving a test dataset of patient data.
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): Not applicable. "Ground truth" in the context of this device refers to the mechanical properties and performance standards defined by ASTM F2077 and assessed through engineering tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device's performance is established by the mechanical testing standards outlined in ASTM F2077. This standard defines the methodologies and expected performance for intervertebral body fusion devices under various loading conditions (static compression shear, static axial compression, dynamic compression shear, dynamic axial compression).
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the document describes the clearance of a physical medical implant (ProLift Pivot Expandable Spacer System) based on its substantial equivalence to previously cleared devices, supported by mechanical performance data against recognized ASTM standards.

Summary

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January 23, 2025

Life Spine, Inc. Angela Batker RA/QA Manager 13951 Quality Drive Huntley, Illinois 60142

Re: K243668

Trade/Device Name: ProLift Pivot Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 21, 2024 Received: November 27, 2024

Dear Ms. Batker:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Katherine D. Kavlock -S

for

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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Indications for Use

Submission Number (if known)

K243668

Device Name

ProLift Pivot Expandable Spacer 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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K243668 - 510(k) Summary ProLift Pivot Expandable Spacer System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Angela BatkerLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	November 26th, 2024
Trade Name:	ProLift Pivot Expandable Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, CFR 888.3080, Class II
Primary Predicate:	Life Spine ProLift Expandable Spacer System (K190488)
Additional Predicate:	Spinal Elements Lucent Xp Curved (K202298)Globus Altera Spacer (K140411)Life Spine ProLift Micro (K212520, K223430)Life Spine Steerable Plateau Ti (K193521)

Device Description:

The ProLift implants are fabricated and manufactured from titanium alloy (Ti-6Al-. 4V ELI) as described by ASTM F136.

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. The ProLift Pivot-U implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537.

The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All ProLift Pivot implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Pivot Expandable Spacer System components with components from any other system or manufacturer.

Intended Use of the Device:

The ProLift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the level involved. It is to be used in patients who have had at least six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Technological Characteristics:

The ProLift Pivot Expandable System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use and sizing.

Material:

This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136) and Cobalt Chrome (CO- 26Cr-6MO) as described by ASTM F1537. This is the same material used in the predicate devices.

Performance Data:

Static compression shear, Static Axial Compression, Dynamic Compression Shear and Dynamic Axial Compression according to ASTM F2077 was presented to demonstrate the substantial equivalency of the Life Spine ProLift Expandable Spacer System (K190488).

Substantial Equivalence:

The ProLift Pivot Expandable System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

Conclusion:

The information presented demonstrates the substantial equivalency of The ProLift Pivot Expandable System.

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.