PSX Interbody System

K211873 · Alphatec Spine, Inc. · MAX · Aug 10, 2021 · Orthopedic

Device Facts

• Record ID: K211873
• Device Name: PSX Interbody System
• Applicant: Alphatec Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (L1-L2 to L5-S1) for the treatment of degenerative disc disease (DDD) with up to Grade 1 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 PSX 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 lumbar spine.

Device Story

PSX Interbody System is a lordotic expandable lumbar intervertebral body fusion device; inserted via posterior surgical approach. System includes spacers, inserters, trials, and instruments. Spacers feature anti-migration teeth and gritblast surface treatment. Device restores sagittal alignment and provides indirect decompression. Used by surgeons in clinical settings for spinal fusion procedures. Benefits patients by stabilizing the spine and facilitating fusion in DDD cases.

Clinical Evidence

No clinical data. Substantial equivalence determination is based on nonclinical bench testing, including static and dynamic axial compression, static and dynamic compression shear, push-out/expulsion, and subsidence analysis.

Technological Characteristics

Manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Lordotic expandable design. Features anti-migration teeth and gritblast surface treatment. Mechanical device; no software or energy source.

Indications for Use

Indicated for spinal fusion in skeletally mature patients at one or two contiguous levels (L1-S1) for degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis. Requires at least six months of failed non-operative treatment. Used with autograft/allograft and supplemental lumbar fixation.

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

• IndentiTi Porous Interbody System (K183705)
• Globus Rise Spacers (K171848)
• Asfora Bullet Cage System (K112648)
• K2M Mojave Expandable Interbody System (K193203)
• Xsert Expandable Interbody System (K160959)
• Novel ALIF Spinal Spacer System (K090782)
• ATEC Lateral Interbody System (K191311)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 10, 2021

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

Re: K211873

Trade/Device Name: PSX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 16, 2021 Received: June 17, 2021

Dear Ms. 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

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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 (OS) 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 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)

### K211873

Device Name PSX Interbody System

### Indications for Use (Describe)

The PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (L1-L2 to L5-S1) for the treatment of degenerative disc disease (DDD) with up to Grade 1 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 PSX 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 lumbar spine.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the "atec" logo. The "a" is green, and the "tec" is dark blue. There is a horizontal line under the logo.

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: | June 16, 2021 |
| II. | DEVICE | |
| | Name of Device: | PSX Interbody System |

| Name of Device: | PSX Interbody System |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device with bone graft, lumbar<br>(21 CFR 888.3080) |
| Regulatory Class: | Class II |
| Product Code: | MAX |

#### III. LEGALLY MARKETED PREDICATE DEVICES

| 510(k) | Product Code | Trade Name | Manufacturer |
|------------------------------|------------------|-------------------------------------------|-----------------|
| Primary Predicate Device | | | |
| K183705 | MAX | IndentiTi Porous Interbody System | Alphatec Spine |
| Additional Predicate Devices | | | |
| K171848 | MAX | Globus Rise Spacers | Globus Medical |
| K112648 | MAX | Asfora Bullet Cage System | Medical Designs |
| K193203 | MAX | K2M Mojave Expandable<br>Interbody System | K2M |
| K160959 | MAX | Xsert Expandable Interbody<br>System | X-Spine Systems |
| K090782 | MAX, MQP | Novel ALIF Spinal Spacer System | Alphatec Spine |
| K191311 | MAX, OVD,<br>PHM | ATEC Lateral Interbody System | Alphatec Spine |

#### DEVICE DESCRIPTION IV.

The subject PSX Interbody System is a lordotic expandable lumbar intervertebral body fusion system designed to be inserted through a posterior surgical approach. The subject

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Image /page/4/Picture/1 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, while the rest of the letters are dark blue. There is a horizontal line underneath the word "atec". The letters are in a sans-serif font.

interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The PSX 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 anti-migration teeth and gritblast treatment on the bone-contacting endplate surfaces.

The purpose of this submission is to gain 510(k) clearance to the PSX Interbody System.

#### V. INDICATIONS FOR USE

The PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (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 PSX 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 lumbar spine.

#### 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 PSX 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/Expulsion
- Subsidence analysis

The results demonstrate that the subject PSX 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.

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Image /page/5/Picture/1 description: The image shows the "atec" logo. The "a" is green, and the "tec" is black. There is a black line underneath the logo.

Traditional 510(k) Premarket Notification PSX Interbody System

# 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.