(123 days)
Not Found
No
The device description and intended use clearly describe a mechanical implant system for spinal fusion, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is an orthopedic implant for spinal fusion and stabilization, which is a structural and mechanical therapeutic intervention, not a device that delivers a therapeutic substance or energy as typically defined for therapeutic devices in many regulatory contexts.
No
The device description clearly states it is a plate system (plates, screws, and lockers) used for anterior screw fixation to the cervical spine as an adjunct to fusions. It is a physical implant used for immobilization and fusion, not for diagnosing conditions.
No
The device description explicitly states it is composed of plates, screws, and lockers made from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior screw fixation to the cervical spine (C2-C7)" and is used in "immobilization of the spine as an adjunct to fusions." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details plates, screws, and lockers made from titanium alloy, which are components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions 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 (defined as kyphosis, lordosis, or scoliosis)
- · pseudoarthrosis
- · failed previous fusion
- · spinal stenosis
Product codes
KWQ
Device Description
The Prase-AP Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, five-level fusion configurations. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Static compression bending, Static torsion and Fatigue compression bending test were performed according to ASTM F1717 on a worst-case, cervical plate construct.
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.
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January 29, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
GBS Commonwealth Co., Ltd. Jimmy Kim RA C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 South Korea
Re: K202878
Trade/Device Name: Prase-AP 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: December 4, 2020 Received: December 7, 2020
Dear Jimmy Kim:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
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
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Indications for Use
510(k) Number (if known) K202878
Device Name
Prase-AP Anterior Cervical Plate System
Indications for Use (Describe)
The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions 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 (defined as kyphosis, lordosis, or scoliosis)
- · pseudoarthrosis
- · failed previous fusion
- · spinal stenosis
| Type of Use (Select one or both, as applicable) |
|---|
| ☐ Original |
| ☐ Amended |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the text "K202878 Page 1 of 3" at the top. Below the text is the logo for GBS Commonwealth. The logo is in blue and features the letters GBS in a stylized font. The word "COMMONWEALTH" is written in smaller letters below the GBS letters.
SUMMARY
The following summary is being submitted as required by 21 CFR 807.92(a):
1. Device Identification
| Submitter: | GBS Commonwealth Co., Ltd.
#C-309, 168 Gasan Digital 1-ro, Geumcheon-Gu Seoul,
South Korea
Phone. 82-2-6925-4469
e-mail: Jimmy.kim@gbscommonwealth.com |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jimmy Kim |
| Date prepared | September, 24, 2020 |
| Trade Name | Prase-AP Anterior Cervical Plate System |
|---|---|
| Regulatory Class | Class II |
| Regulation | |
| Name/Common Name | Anterior Cervical Plate |
| Classification Name | Spinal Intervertebral body fixation orthosis |
| (21 CFR 888.3060) | |
| Panel | Orthopedic |
| Product Code | KWQ |
2. Purpose of 510(k)
The GBS Commonwealth Co. Ltd., here by submits this pre-submission: for Initial product Introduction of Prase-AP Anterior Cervical Plate System
3. Predicate or legally marketed devices which are substantially equivalent
- Primary Predicate Device: : K190425 CastleLoc-P Anterior Cervical Plate System
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Image /page/4/Picture/0 description: The image shows the text "K202878" and "Page 2 of 3" at the top. Below the text is the logo for GBS Commonwealth. The logo is in blue and features the letters "GBS" in a large, bold font. Below the letters is the word "COMMONWEALTH" in a smaller font.
4. Description of the Device
The Prase-AP Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws
per plate. The plates are offered in one-level, three-level, four-level, five-level fusion configurations. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.
5. Indication for Use
The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions 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 (defined as kyphosis, lordosis, or scoliosis),
- . pseudoarthrosis.
- failed previous fusion, •
- spinal stenosis. .
Comparison of the technological characteristics of the subject and predicate 6. devices
The Prase-AP Anterior Cervical Plate System is considered substantially
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Image /page/5/Picture/0 description: The image shows the text "K202878 Page 3 of 3" at the top. Below the text is the logo for GBS Commonwealth. The logo is in blue and features the letters GBS in a stylized font. The word "COMMONWEALTH" is written in smaller letters below the letters GBS.
equivalent to the primary predicate CastleLoc-P Anterior Cervical Plate System K190425. They are similar in design, material, scientific technologies and indications for use.
7. Performance Testing
Static compression bending, Static torsion and Fatigue compression bending test were performed according to ASTM F1717 on a worst-case, cervical plate construct.
8. Conclusion
The Prase-C Anterior Cervical Plate System is substantially equivalent to legally marketed predicates.