(104 days)
Not Found
No
The device description and intended use focus on mechanical stabilization and do not mention any computational or analytical functions that would typically involve AI/ML. The performance studies compare mechanical properties to predicate devices.
Yes.
The device is used for temporary stabilization of the anterior spine to facilitate spinal fusions in patients with various spinal conditions, indicating a therapeutic purpose.
No
This device is an implantable system (plates, screws, rivets) used for the stabilization of the anterior spine; it does not diagnose medical conditions.
No
The device description explicitly states that the system consists of physical components made from titanium or titanium alloy, including bone plates, locking rivets, bone screws, and associated instruments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "temporary stabilization of the anterior spine... during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details physical components like bone plates, locking rivets, and bone screws made from titanium. These are physical devices implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Slimplicity Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Slimplicity Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; spinal stenosis; pseudarthrosis; and failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Slimplicity Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates, locking rivets pre-assembled, and bone screws, which can be assembled with associated instruments to provide immobilization of the cervical spine. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine from C2 to T1, cervical spine
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)
Testing in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" of the Slimplicity Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the Deltaloc Anterior Cervical Plate System (K993513), Synthes Spine Anterior CSLP System (K030866) and the Reflex Anterior Cervical Plate System (K031702).
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
APR 18 2006
510 (k) Summary of Safety and Effectiveness
| Date Summary Prepared: | January 3, 2006 |
|---|---|
| Submitter Information: | Spinal USA |
| 213 Eastside Lane | |
| Brandon, MS 39047 | |
| Contact Name: | Jeffrey Johnson |
| Phone: | 601-992-7668 |
| Fax: | 601-992-0380 |
| E-mail: | jeff@spinalusa.com |
| Device Trade Name: | Slimplicity Anterior Cervical Plate System |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Anterior Cervical Plate System | |
| Regulatory Number: | 888.3060 |
| Classification: | Class II |
| Product Code: | KWQ |
INTENDED USE:
The Slimplicity Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; spinal stenosis; pseudarthrosis; and failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
DEVICE DESCRIPTION:
The Slimplicity Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates, locking rivets pre-assembled, and bone screws, which can be assembled with associated instruments to provide immobilization of the cervical spine. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
1
EQUIVALENT DEVICE:
Testing in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" of the Slimplicity Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the Deltaloc Anterior Cervical Plate System (K993513), Synthes Spine Anterior CSLP System (K030866) and the Reflex Anterior Cervical Plate System (K031702).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal USA c/o Mr. Jeffrey Johnson 213 Eastside Lane Brandon, Mississippi 39047
APR 1 8 2006
Re: K060025
Trade/Device Name: Slimplicity Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: March 22, 2006 Received: March 29, 2006
Dear Mr. Johnson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Jeffery Johnson
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hebert Leonard
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060025
Device Name: Slimplicity Anterior Cervical Plate System
Indications for Use:
The Slimplicity Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; spinal stenosis; pseudarthrosis; and failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Lemer(a)
Division of General, Restorative, and Neurological Devices
510(k) Number K060025