Calibrate LTX Interbody System

K222455 · Alphatec Spine, Inc. · MAX · Nov 18, 2022 · Orthopedic

Device Facts

• Record ID: K222455
• Device Name: Calibrate LTX Interbody System
• Applicant: Alphatec Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.

Device Story

Lordotic expandable interbody fusion system; inserted via lateral or anterolateral approach. Restores sagittal alignment; provides indirect decompression. Components include spacers, inserters, trials, and instruments. Spacers feature antimigration teeth and grit-blast surfaces. Used in clinical settings by surgeons. Implants expand to restore disc height; bone screws provide additional fixation for high-angle expansion (>20°). Benefits patients by stabilizing spinal segments and facilitating fusion in degenerative conditions.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), push-out testing (ASTM F04-25-02-02 Draft), and subsidence analysis.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI, ASTM F136) and PEEK Optima LT1 (ASTM F2026). Design: Lordotic expandable interbody spacer with antimigration teeth and grit-blast surface treatment. Fixation: Optional titanium alloy bone screws. Mechanical testing per ASTM F2077.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion at one or two contiguous levels in the thoracolumbar spine (T1-S1). Treats symptomatic degenerative disc disease (DDD), including thoracic disc herniation and lumbar DDD with up to Grade I spondylolisthesis or retrolisthesis. Requires at least six months of failed non-operative treatment. Must be used with autograft/allograft and supplemental fixation; spacers expanded >20° require additional provided bone screws.

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

• IdentiTi and Transcend Interbody Systems (K211805)
• PSX Interbody System (K211873)
• ELSA Spacers (K161379)
• Prolift Expandable System (K191005)
• IdentiTi Porous Ti Interbody System (K183705)

Submission Summary (Full Text)

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November 18, 2022

Alphatec Spine, Inc. Cynthia Dorne Sr. Manager, Regulatory Affairs 1950 Camino Vida Roble Carlsbad, California 92008

Re: K222455

Trade/Device Name: Calibrate LTX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, PHM Dated: October 25, 2022 Received: October 26, 2022

Dear Cynthia Dorne:

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

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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 ([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)

K222455

Device Name Calibrate LTX Interbody System

### Indications for Use (Describe)

The Callbrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain).

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Callbrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.

Type of Use (*Select one or both, as applicable*)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------|
|------------------------------------------------------------------------------------------------|-----------------------------------------------|

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K222455

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

| I. | SUBMITTER: | Alphatec Spine, Inc.<br>1950 Camino Vida Roble<br>Carlsbad, CA 92008<br>Phone: [phone]<br>Fax: [phone] |
|-----|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Cynthia Dorne<br>Manager, Regulatory Affairs<br>Contact Phone: [phone] |
| | Date Summary Prepared: | August 12, 2022 |
| II. | DEVICE | |
| | Name of Device:<br>Common or Usual Name:<br>Classification Name: | Calibrate LTX Interbody System<br>Intervertebral body fusion device<br>Intervertebral fusion device with bone graft, lumbar<br>Intervertebral fusion device with integrated fixation<br>lumbar<br>Intervertebral fusion device with bone graft, thoracic |
| | Regulation Number:<br>Regulatory Class:<br>Product Code: | 21 CFR 888.3080<br>Class II<br>MAX, OVD, PHM |

#### III. LEGALLY MARKETED PREDICATE DEVICES

| 510(k) | Product Code | Trade Name | Manufacturer |
|------------------------------|-----------------------|---------------------------------------------|----------------|
| Primary Predicate Device | | | |
| K211805 | MAX, PHM,<br>OVD, ODP | IdentiTi and Transcend Interbody<br>Systems | Alphatec Spine |
| Additional Predicate Devices | | | |
| K211873 | MAX | PSX Interbody System | Alphatec Spine |
| K161379 | OVD, MAX | ELSATM Spacers | Globus Medical |
| K191005 | MAX | Prolift Expandable System | Life Spine |
| K183705 | MAX, PHM,<br>OVD, ODP | IdentiTi Porous Ti Interbody<br>System | Alphatec Spine |

#### IV. DEVICE DESCRIPTION

The subject Calibrate LTX Interbody System is a lordotic expandable thoracolumbar intervertebral body fusion system designed to be inserted through a lateral or anterolateral

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surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate LTX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with antimigration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody System offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136. The purpose of this submission is to gain 510(k) clearance to the Calibrate LTX Interbody System.

#### V. INDICATIONS FOR USE

The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.

#### VI. TECHNOLOGICAL COMPARISON TO PREDICATES

The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.

#### VII. PERFORMANCE DATA

Nonclinical testing performed on the Calibrate LTX Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:

- · Static and Dynamic Axial Compression (per ASTM F2077)
- · Static and Dynamic Compression Shear (per ASTM F2077)
- · Push-out (per ASTM F04-25-02-02 Draft)

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K222455

- Subsidence analysis
The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing.

### Clinical Information

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

## VIII. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.