(54 days)
Not Found
No
The summary describes a mechanical interbody fusion system and its materials, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for spinal fusion procedures to treat degenerative disc disease, which involves addressing a medical condition (back pain of discogenic origin) to restore function and improve the patient's health.
No
The PSX Interbody System is an implantable device used for spinal fusion procedures, not for diagnosing medical conditions. Its purpose is to provide stability and support for fusion, treating degenerative disc disease, rather than identifying or characterizing diseases.
No
The device description explicitly states the system consists of physical components manufactured from titanium alloy, including interbody spacers, inserters, trials, and instruments. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- PSX Interbody System Function: The PSX Interbody System is a surgical implant designed to be placed within the spine to facilitate bone fusion. It is a physical device used in vivo (within the body) during a surgical procedure.
- Lack of Specimen Analysis: The description of the PSX Interbody System does not mention any interaction with or analysis of specimens taken from the body. Its function is purely mechanical and structural within the spine.
Therefore, based on the provided information, the PSX Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
MAX
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L1-L2 to L5-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K183705, K171848, K112648, K193203, K160959, K090782, K191311
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|-----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Cynthia Dorne
Manager, Regulatory Affairs
Contact Phone: (760) 494-6740 |
| | 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 |
| (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 | |
| Interbody System | K2M | ||
| K160959 | MAX | Xsert Expandable Interbody | |
| System | X-Spine Systems | ||
| K090782 | MAX, MQP | Novel ALIF Spinal Spacer System | Alphatec Spine |
| K191311 | MAX, OVD, | ||
| 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.