(26 days)
Not Found
No
The provided text describes a medical implant system (ProAM ALIF System) and makes no mention of AI models, machine learning, or any computational or analytical functions that would suggest the presence of an AI model. It focuses on the physical components, materials, and surgical indications of the device.
Yes
The device is an intervertebral body fusion system intended for spinal fusion procedures in patients with degenerative disc disease, degenerative spondylolisthesis, and/or spinal stenosis. These are conditions that cause medical issues, and the device is used to treat them, which aligns with the definition of a therapeutic device.
No
Explanation: The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures. Its purpose is to provide structural support for fusion, not to diagnose a condition.
No
The device is a physical intervertebral body fusion system made of titanium alloy, designed for spinal fusion procedures. It includes physical components like the intervertebral body fusion device, bone screws, impacted screws, and curved anchors. It is clearly a hardware device, not software.
No.
The device is an intervertebral body fusion system, which is an implantable surgical device, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
Interbody devices used with three fully threaded bone screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation. Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three fixation components (OLIF devices and 2-Hole ALIF devices) or used with anchors or impacted screws must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Product codes
OVD, MAX
Device Description
The ProAM™ ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and fixation devices manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).
The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.
The fixation devices consist of Bone Screws, Impacted Screws, and Curved Anchors. Bone Screws are available in various diameters and lengths and engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone. Impacted Screws are available in various lengths. They are first impacted through the intervertebral body fusion device into bone and then turned to further fixate to the bone. Curved Anchors are available in various lengths and are impacted into the bone through the intervertebral body fusion device.
The purpose of this premarket notification is to add the Impacted Screws and Curved Anchors as fixation devices for the ProAM ALIF System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral (L2-S1) spine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following mechanical testing was performed:
- Static and dynamic cantilever testing per ASTM F2193
- Expulsion
The mechanical testing demonstrated that the device performs as well or better than the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
FDA 510(k) Clearance Letter - ProAM ALIF System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 24, 2025
Pro Surgical, Inc.
Jason Blain
Chief Executive Officer
1910 Palomar Point Way, Suite 201
Carlsbad, California 92008
Re: K251644
Trade/Device Name: ProAM ALIF System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVD, MAX
Dated: May 29, 2025
Received: May 29, 2025
Dear Jason Blain:
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.
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"
Page 2
U.S. FOOD & DRUG ADMINISTRATION
June 24, 2025
Pro Surgical, Inc.
Jason Blain
Chief Executive Officer
1910 Palomar Point Way, Suite 201
Carlsbad, California 92008
Re: K251644
Trade/Device Name: ProAM ALIF System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVD, MAX
Dated: May 29, 2025
Received: May 29, 2025
Dear Jason Blain:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
K251644 - Jason Blain Page 2
(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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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).
Page 3
K251644 - Jason Blain Page 3
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K251644
Device Name
ProAM ALIF System
Indications for Use (Describe)
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
Interbody devices used with three fully threaded bone screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation. Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three fixation components (OLIF devices and 2-Hole ALIF devices) or used with anchors or impacted screws must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Page 5
510(k) Summary
510(k) Number K251644
Date Prepared: June 18, 2025
Submitted By
Pro Surgical, Inc.
1910 Palomar Point Way, Suite 201
Carlsbad, CA 92008
858-761-6262
Contact:
Jason Blain
jblain@pro-surgical.com
858-761-6262
Device Name
Device Trade Name: ProAM ALIF System
Common Name: Intervertebral Body Fusion Device
Classification Name: Intervertebral Fusion Device with Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 12 CFR § 888.3080
Product Code: OVD, MAX
Predicate Devices
Primary Predicate Device
ProAM ALIF System – K240126
Additional Predicate Devices
Astura El Capital Anterior Lumbar Interbody Fusion – K222554
Device Description
The ProAM™ ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and fixation devices manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).
Page 6
The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.
The fixation devices consist of Bone Screws, Impacted Screws, and Curved Anchors. Bone Screws are available in various diameters and lengths and engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone. Impacted Screws are available in various lengths. They are first impacted through the intervertebral body fusion device into bone and then turned to further fixate to the bone. Curved Anchors are available in various lengths and are impacted into the bone through the intervertebral body fusion device.
The purpose of this premarket notification is to add the Impacted Screws and Curved Anchors as fixation devices for the ProAM ALIF System
Indications for Use
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
Page 7
Interbody devices used with three fully threaded bone screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation.
Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three fixation components (OLIF devices and 2-Hole ALIF devices) or used with anchors or impacted screws must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Indications for Use Comparison
The Indications for Use of the ProAM ALIF System are identical to those for the listed predicate devices.
Technological Comparison
The ProAM ALIF System is substantially equivalent to the predicate devices when considering design, configurations and sizes, intended use, material composition, manufacture, function, and mechanical performance.
Performance Data
The following mechanical testing was performed:
- Static and dynamic cantilever testing per ASTM F2193
- Expulsion
The mechanical testing demonstrated that the device performs as well or better than the predicates.
Conclusions
The ProAM ALIF System is substantially equivalent to the legally marketed predicate devices based on a comparison of indications for use, design, intended use, material composition, function, and mechanical performance.