(259 days)
Not Found
No
The device description and intended use are for a passive spinal implant and associated instrumentation, with no mention of AI/ML capabilities or data processing.
No.
The device functions as an implant for internal fixation, providing stabilization until spinal fusion develops, rather than directly treating a disease or condition itself.
No
The device is described as an implantable plate and screws for spinal fixation, designed to provide stabilization during surgical treatment of various spinal conditions. Its function is to provide mechanical support, not to diagnose a condition.
No
The device description clearly states it is an "implant device made from a titanium alloy" and describes physical components like plates and screws, indicating it 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 Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Sphynx™ is described as an implant device made from a titanium alloy, designed for surgical implantation in the spine.
- Intended Use: The intended use is to provide stabilization during spinal surgery and promote fusion. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The information clearly indicates that this is a surgical implant used directly within the patient's body for structural support and stabilization, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible.
This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications:
- Tumor of the vertebral body
- Fracture of the anterior spine (trauma)
- Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Scoliosis
- Lordotic deformities of the spine
- Spinal stenosis
- Failed previous spine surgery
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Sphynx is an implant device made from a titanium alloy Ti-6AI-4V ELI. It is to be implanted from the anterior-lateral approach. The Sphynx™ implant is an antero-lateral plate aimed at performing internal fixation of the thoraco-lumbar area of the spine (T1-L5), in addition to a solid intervertebral arthrodesis. The Sphynx™ instrumentation is composed of plates with anatomical conformation for cyphosis and lordosis. These plates are available in lengths 45-135mm increasing increments of 10mm. The fixation screws also consist of a variety of lengths and diameters. The safety screw is a 5mm diameter screw available in lengths starting at 24mm increasing in increments of 5mm to an overall length of 55mm. The two other fixation screws are available in diameters of 6mm and 7mm starting at 25mm and increasing in increments of 5mm to an overall length of 60mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoraco-lumbar area of the spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression bending, Static Torsion bending and and Dynamic Compression bending per ASTM F1717-14 were met. No clinical testing was performed.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Eden Spine, LLC % Ms. Tamala Wampler Regulatory and Quality Consultant Novus Management Group, LLC 6686 Dimmick Road West Chester, Ohio 45069
Re: K160982
Trade/Device Name: SphynxTM Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 26, 2016 Received: November 30, 2016
Dear Ms. Wampler:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160982
Device Name Sphynx™
Indications for Use (Describe)
The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible.
This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications:
-
Tumor of the vertebral body
-
Fracture of the anterior spine (trauma)
-
Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
-
Pseudoarthrosis
-
Spondylolysis
-
Spondylolisthesis
-
Scoliosis
-
Lordotic deformities of the spine
-
Spinal stenosis
-
Failed previous spine surgery
| 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) |
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3
| Submitter's Name: | Eden Spine LLC |
|---|---|
| Submitter's Address: | 377 Maitland Avenue, Suite 1015 |
| Altamonte Springs, Florida 32701 | |
| Submitter's Telephone: | 407-900-9986 |
| Company Contact Person: | Mr. Guillaume Viallaneix |
| CEO | |
| Contact Person: | Tamala J. Wampler |
| Novus Management Group, LLC. | |
| 513-593-4944 | |
| Date Summary was Prepared: | 15 March 2016 |
| Trade or Proprietary Name: | SphynxTM |
| Common or Usual Name: | Thoracolumbar Plates |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Sphynx is an implant device made from a titanium alloy Ti-6AI-4V ELI. It is to be implanted from the anterior-lateral approach. The Sphynx™ implant is an antero-lateral plate aimed at performing internal fixation of the thoraco-lumbar area of the spine (T1-L5), in addition to a solid intervertebral arthrodesis. The Sphynx™ instrumentation is composed of plates with anatomical conformation for cyphosis and lordosis. These plates are available in lengths 45-135mm increasing increments of 10mm. The fixation screws also consist of a variety of lengths and diameters. The safety screw is a 5mm diameter screw available in lengths starting at 24mm increasing in increments of 5mm to an overall length of 55mm. The two other fixation screws are available in diameters of 6mm and 7mm starting at 25mm and increasing in increments of 5mm to an overall length of 60mm.
INDICATIONS FOR USE
The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible.
This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications:
- Tumor of the vertebral body
- · Fracture of the anterior spine (trauma)
- · Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
- Pseudoarthrosis
- · Spondylolysis
- · Spondylolisthesis
- Scoliosis
- · Lordotic deformities of the spine
4
· Spinal stenosis
- · Failed previous spine surgery
TECHNICAL CHARACTERISTICS
Sphynx " is made from titanium alloy that conforms to ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- . Indications for Use (nearly identical)
- . Materials of manufacture (identical)
- Structural support mechanism (identical) ●
The additions to the system include the following implants and instruments: 8.5mm and 9.0mm diameter screws and the associated instruments.
| Table 5-1 Predicate Devices | ||
|---|---|---|
| ----------------------------- | -- | -- |
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | Primary |
| K962784 | Ultium Spinal Plating System | Smith & Nephew Inc. | |
| Orthopaedic Division | Additional |
Eden Spine Sphynx " was evaluated to demonstrate equivalence to the predicate devices. Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression bending, Static Torsion bending and and Dynamic Compression bending per ASTM F1717-14 were met. No clinical testing was performed.
CONCLUSION
The Sphynx™ has been tested per ASTM F1717 in static compression bending, dynamic compression bending and static torsion bending and were considered substantially equivalent to other legally marketed devices. The subject Sphynx™ has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The overall technology characteristics lead to the conclusion that the Sphynx™ is substantially equivalent to the predicate devices.