(106 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The system is described as an "ALTUM Anterior Cervical Plate System" intended for "anterior screw fixation to the cervical spine" to be used as an "adjunct to fusion". This indicates it is used to treat conditions affecting the cervical spine, which is a therapeutic application.
No
This device is an anterior cervical plate system intended for screw fixation to the cervical spine as an adjunct to fusion. It is a therapy device, not a diagnostic one.
No
The device description clearly details a physical implant (cervical plate and screws) and associated instruments, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The ALTUM Anterior Cervical Plate System is a physical implant designed for surgical fixation of the cervical spine. It is used in the body, not to test samples from the body.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine" as an "adjunct to fusion." This is a surgical procedure, not a diagnostic test.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors, .
- . deformity,
- pseudarthrosis, .
- . failed previous fusion,
- spinal stenosis. .
Product codes
KWQ
Device Description
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to C7)
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
Non-clinical Test Summary:
The following tests were conducted:
ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectorny Model. Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests.
Clinical Test Summary: No clinical studies were performed
Conclusions Nonclinical and Clinical:
The ALTUM Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SpineCraft, LLC
510(k) Premarket Notification ALTUM Anterior Cervical Plate
MAR 1 5 2011
510(k) Summarv for the ALTUM Anterior Cervical Plate
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ALTUM Anterior Cervical Plate
Date Prepared: 11/24/210
Submitter: SpineCraft. LLC 2215 Enterprise Drive Westchester, IL 60154 USA Tel: 1 708-531-9700. Fax: 1708- 531-9702
Establishment Registration No: Trade name: Common Name: Classification Name:
Product Code: Classification Panel: Contact Person: Ami Akallal-Asaad Director of Regulatory Affairs. SpineCraft, LLC a.asaad@spinecraft.com
3004717358 ALTUM Anterior Cervical Plate System Anterior Cervical Plate Spinal intervertebral body fixation orthosis Per 21 CFR 88.3060 KWQ Class II 87
Predicate or legally marketed devices which are substantially equivalent:
Envision2 Anterior Cervical Plate System (K020649) / Ortho Development Spider Cervical Plating System (K052292) / X-Spine Systems
Description of the device:
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.
Materials:
1
SpineCraft, LLC
Ti-6Al-4V per ASTM F136
Function:
The ALTUM Anterior Cervical Plate system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion.
Substantial equivalence claimed to predicate devices
ALTUM Anterior Cervical Plate system is substantially equivalent to the Envision2 Anterior Cervical Plate System (K971730) and Spider Cervical Plating System (K052292) in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the ALTUM Anterior Cervical Plate system to these predicate devices.
| Device
Name
Items | ALTUM Anterior
Cervical Plate | Envision2 Anterior
Cervical Plate
System | Spider Cervical
Plating System |
|---------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Sponsor | SpineCraft | Ortho Development | X-Spine Systems |
| 510(k)
Number | Current submission | K020649 | K052292 |
| Device
Classification
Name/Product
Codes | Spinal intervertebral
body fixation orthosis
per 21 CFR 88.3060
KWQ | Spinal intervertebral
body fixation orthosis
per 21 CFR 88.3060
KWQ | Spinal intervertebral
body fixation orthosis
per 21 CFR 88.3060
KWQ |
| Classification | II | II | II |
| Material | Ti-6Al-4V per ASTM
F136 | Ti-6Al-4V per ASTM
F136 | Ti-6Al-4V per ASTM
F136 |
| # levels | multiple | multiple | multiple |
| Graft window | Yes | Yes | Yes |
| Variable angle
screw | Yes | Yes | Yes |
| Fixed screw | Yes | Yes | Yes |
| Screw size | Ø4.0, Ø4.5mm
variety of lengths | Ø4.0, Ø4.35mm
variety of lengths | Ø4.0, Ø4.25mm
variety of lengths |
| Pre-lordosed | Yes | Yes | Yes |
| Sterility | Non-sterile, sterilized
at hospital | Non-sterile, sterilized
at hospital | Non-sterile, sterilized
at hospital |
Figure (5)
2
510(k) Premarket Notification ALTUM Anterior Cervical Plate
Intended Use:
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, �
- trauma (i.e. fractures or dislocations), �
- tumors, .
- . deformity,
- pseudarthrosis, .
- . failed previous fusion,
- spinal stenosis. .
Non-clinical Test Summary:
The following tests were conducted:
ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectorny Model. Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate systems.
Clinical Test Summary
No clinical studies were performed
Conclusions Nonclinical and Clinical
The ALTUM Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
P.g 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right. The bird is drawn with simple, flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SpineCraft, LLC % Ms. Ami Akallal-Asaad Director of Requlatory Affairs 2215 Enterprise Drive, Suite 1504 Westchester, Illinois 60154
MAR 1 5 2011
Re: K103505
Trade/Device Name: ALTUM Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: February 28, 2011 Received: March 01, 2011
Dear Ms. Akallal-Asaad:
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. Ilisting 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
4
Page 2 – Ms. Akallal-Asaad
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (8:00) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Aling B. n.t
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
A. Indication for Use Statement
KIO3505 510(k) Number (if known): __ Device Name: ALTUM Anterior Cervical Plate System
Indication for Use:
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondvlolisthesis. .
- trauma (i.e. fractures or dislocations), .
- tumors. .
- deformity, .
- pseudarthrosis.
- failed previous fusion.
- spinal stenosis.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KID3505 510(k) Number_