ProLift Micro Expandable Spacer System

K223430 · Life Spine, Inc. · MAX · May 4, 2023 · Orthopedic

Device Facts

• Record ID: K223430
• Device Name: ProLift Micro Expandable Spacer System
• Applicant: Life Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an interbody fusion device, the ProLift® Micro 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 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 Story

ProLift® Micro Expandable Spacer System is an intervertebral body fusion device; used in spinal fusion procedures. Device is implanted by surgeons in clinical settings. Implant is expandable (8mm to 16mm height) to accommodate patient anatomy; features teeth on superior/inferior surfaces to prevent migration/rotation. Device is packed with autograft or allogeneic bone graft to promote fusion. Used in conjunction with supplemental internal spinal fixation (e.g., pedicle screws). Benefits include restoration of disc height and stabilization of spinal segments in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical performance demonstrated via static axial compression, dynamic axial compression, static shear, and dynamic shear testing in accordance with ASTM F2077.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Expandable interbody spacer; height range 8mm-16mm. Features surface teeth for vertebral interface. Sterile, single-use. Mechanical testing per ASTM F2077.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade 1 spondylolisthesis, who have failed at least six months of non-operative treatment. Includes patients with previous non-fusion spinal surgery at the involved level(s).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Life Spine ProLift Micro Expandable System (K212520)
• Life Spine ProLift Expandable System (K190488)
• Life Spine ProLift Expandable Spacer System (K153400)
• Globus Rise Spacer System (K113447)

Submission Summary (Full Text)

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May 4, 2023

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

Re: K223430

Trade/Device Name: ProLift® Micro Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 5, 2023 Received: April 7, 2023

Dear Angela 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 (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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Brent Showalter -S

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

510(k) Number (if known) K223430

Device Name ProLift® Micro Expandable Spacer System

#### Indications for Use (Describe)

When used as an interbody fusion device, the ProLift® Micro 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 radios. 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 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.

| 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) Summarv ProLift® Micro Expandable Spacer System

| Submitted By: | Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker<br>Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | November 8th, 2022 |
| Trade Name: | ProLift® Micro Expandable Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, CFR 888.3080, Class II |
| Primary Predicate: | Life Spine ProLift Micro Expandable System (K212520) |
| Additional Predicate: | Life Spine ProLift Expandable System (K190488)<br>Life Spine ProLift Expandable Spacer System (K153400)<br>Globus Rise Spacer System (K113447) |

### Device Description:

The ProLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. 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 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® Micro Expandable System components with components from any other system or manufacturer. The ProLift® Micro Expandable System components should never be reused under any circumstances.

#### Intended Use of the Device:

When used as an interbody fusion device, the ProLift® Micro Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one

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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 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.

#### Technological Characteristics:

The ProLift Micro® Expandable Spacer System is substantially equivalent to the predicate systems in terms of design, materials, 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. This this is the same material used in the predicate devices.

#### Performance Data:

Static Axial Compression, Dynamic Axial Compression, Static Shear and Dynamic Shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the Life Spine ProLift Micro Expandable System (K212520)

#### Substantial Equivalence:

The ProLift® Micro Expandable Spacer 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 Micro® Expandable Spacer System.