(552 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for intervertebral body fusion of the spine to treat degenerative disc disease, which is a therapeutic intervention.
No
The device is an interbody fusion device, designed for structural support and to facilitate bone fusion in the spine. It is a treatment device, not a diagnostic one.
No
The device description clearly details a physical implant (rectangular with openings, teeth, tantalum markers, articulating hub) intended for surgical implantation in the spine. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Pantheon Spinal Pontus Interbody Fusion Device is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Activity: The description focuses on the physical characteristics of the implant and its intended surgical use, not on analyzing biological samples or providing diagnostic information.
Therefore, the Pantheon Spinal Pontus Interbody Fusion Device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interiody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. Pantheon Spinal Pontus Interbody Fusion Device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Pantheon Spinal Pontus Interbody Fusion Device is rectangular with one or more openings through the structure for placement of bone graft. The Epiphany device is hexahedral in geometry with two vertical openings. Pyramidal teeth are incorporated on the inferior and superior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes offered in widths 18-24mm (2mm increments), in lengths 40-60mm (5mm increments), heights 8-16mm (2 mm increments), in 0. 7 and 12 degree lordosis to accommodate differing anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical test results demonstrated that the Pantheon Spinal Interbody Fusion Device is equivalent to the predicate devices. Testing was performed in accordance with :
- ASTM F2077 Test Methods for Intervertebral Body Fusion Devices
- o Static Axial Compression
- o Dynamic Axial Compression
- o Static Compression Shear
- o Dynamic Compression Shear
- · ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of an intervertebral Body Fusion Device Under Static Axial Compression
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2019
Pantheon Spinal, LLC Mr. Dave Lamb 3008 Bee Cave Road, Suite 200 Austin, Texas 78746
Re: K181548
Trade/Device Name: Pantheon Spinal Pontus Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 4, 2018 Received: June 12, 2018
Dear Mr. Lamb:
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 Showalter. PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Pantheon Spinal Pontus Interbody Fusion System
Indications for Use (Describe)
The Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interiody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. Pantheon Spinal Pontus Interbody Fusion Device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K181548 - 510(K) SUMMARY
| Submitter: | Pantheon Spinal, LLC |
|---|---|
| Address: | 3008 Bee Cave Road, Suite 200, Austin, TX 78746 USA |
| Phone: | 512-215 -4888 |
| Contact Name: | Dave Lamb |
| Date prepared: | November 15, 2019 |
| Trade Name: | Pantheon Spinal Pontus Interbody Fusion Device |
| Common Name: | Interbody Fusion Device |
| Device Classification: | Class II |
| Regulation: | 888.3080 |
| Device Product Codes: | MAX |
Device Description:
The Pantheon Spinal Pontus Interbody Fusion Device is rectangular with one or more openings through the structure for placement of bone graft. The Epiphany device is hexahedral in geometry with two vertical openings. Pyramidal teeth are incorporated on the inferior and superior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes offered in widths 18-24mm (2mm increments), in lengths 40-60mm (5mm increments), heights 8-16mm (2 mm increments), in 0. 7 and 12 degree lordosis to accommodate differing anatomic requirements.
Intended Use:
Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interbody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. Pantheon Spinal Pontus Interbody Fusion Device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.
4
Materials:
PEEK Zeniva ZA 500 with markers of Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) and a hub of Titanium Alloy Ti-6AL-4V
Primary Predicate Device:
The Pantheon Spinal Interbody Fusion Device (K113781)
Additional Predicate Devices
Summit Spine Yellowstone Lumbar Interbody Fusion System ( K170572)
Technological Characteristics
The Pantheon Spinal Interbody Fusion System possesses the same technological characteristcs as the predicate devices including basic design, with various footprints and lordosis, sizes (length, height, width) materials, mechanical safety and performances, and intended use.
Performance Data
Biomechanical test results demonstrated that the Pantheon Spinal Interbody Fusion Device is equivalent to the predicate devices. Testing was performed in accordance with :
- ASTM F2077 Test Methods for Intervertebral Body Fusion Devices
- o Static Axial Compression
- o Dynamic Axial Compression
- o Static Compression Shear
- o Dynamic Compression Shear
- · ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of an intervertebral Body Fusion Device Under Static Axial Compression
Conclusion:
The Pantheon Spinal Interbody Fusion System devices ae similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided in this premarket notification supports substantial equivalend of the subject device to the predicate device