(53 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable system designed to fix to the cervical spine as an adjunct to fusion for various medical conditions, directly treating and mitigating conditions like degenerative disc disease, trauma, tumors, and spinal stenosis.
No
The provided SSED indicates the device is an anterior cervical plate system used for screw fixation to the cervical spine as an adjunct to fusion. It is a surgical implant, not a device used to identify or diagnose a disease or condition.
No
The device description explicitly states it consists of bone plates and screws manufactured from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Axis Anterior Cervical Plate System is a surgical implant designed for anterior screw fixation to the cervical spine. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical fixation as an adjunct to fusion in the cervical spine for various conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.
Product codes
KWQ
Device Description
The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
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
The Axis Anterior Cervical Plate System has been tested in the following test modes:
- Static & Dynamic Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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
June 13, 2023
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Southern Medical (Pty) Ltd % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K231145
Trade/Device Name: Axis Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 21, 2023 Received: April 21, 2023
Dear Nathan Wright:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
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Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known) K231145
Device Name
Axis Anterior Cervical Plate System
Indications for Use (Describe)
The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K231145 - 510(K) SUMMARY
| Submitter's Name: | Southern Medical (Pty) Ltd |
|---|---|
| Submitter's Address: | 55 Regency Drive |
| Route 21 Corporate Park | |
| Irene, Centurion, Gauteng 0178 | |
| South Africa | |
| Submitter's Telephone: | +27 12 667 6243/4 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies logo | |
| Date Summary was Prepared: | April 21, 2023 |
| Trade or Proprietary Name: | Axis Anterior Cervical Plate System |
| Common or Usual Name: | Anterior Cervical Plate System |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic – Spinal (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.
INDICATIONS FOR USE
The Axis Anterior Cervical Plate System is intended for use in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours: (d) deformity (defined as kyphosis, lordosis or scoliosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.
TECHNOLOGICAL CHARACTERISTICS
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
- Structural support mechanism ●
- Materials of manufacture ●
- Sizes and features ●
4
Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code | Predicate
Type |
|-------------|-------------------------------------------|--------------------|-----------------|-------------------|
| K201979 | Cervical Plate System | Eminent Spine, LLC | KWQ | Primary |
| K132994 | Anodyne Anterior Cervical
Plate System | CoreLink, LLC | KWQ | Additional |
Performance Data
The Axis Anterior Cervical Plate System has been tested in the following test modes:
- Static & Dynamic Compression Bending per ASTM F1717 ●
- Static Torsion per ASTM F1717 ●
The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Axis Anterior Cervical Plate System is substantially equivalent to the predicate device.