(61 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the physical implant components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an anterior cervical plate system intended for temporary stabilization during spinal fusion, not for providing therapy itself. Its purpose is mechanical support and stabilization.
No
The device is described as an anterior cervical plate system intended for surgical implantation to stabilize the cervical spine as an adjunct to fusion. It is a therapy device, not a diagnostic one.
No
The device description explicitly lists physical components made of titanium alloy (plates, locking caps, bone screws, instruments), indicating it is a hardware-based medical device for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The White Pearl Preferred Angle Anterior Cervical Plate is a surgical implant designed to be physically placed within the body to stabilize the cervical spine. It is a mechanical device, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine" as an "adjunct to fusion." This describes a surgical procedure and the function of an implant, not a diagnostic test.
The information provided about the device's materials, components, surgical approach, and mechanical testing further confirms its nature as a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The White Pearl Preferred Angle Anterior Cervical Plate 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 T1). 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 (defined as kyphosis, lordosis, or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to provide stabilization of the cervical vertebrae for various indications. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The White Pearl Preferred Angle Anterior Cervical Plate is intended to be removed after solid fusion has occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were performed. Non-clinical tests were conducted: Static and dynamic compression testing per ASTM F1717 and Static torsion testing per ASTM F1717. The results of these evaluations indicate that the White Pearl Preferred Angle Anterior Cervical Plate is substantially equivalent to the predicate devices.
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.
K132012, K060025, K000536, K042544 / K082273 / K100070, K132894
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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
April 26, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osseus Fusion Systems, LLC % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K160522
Trade/Device Name: White Pearl Preferred Angle Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 12, 2016 Received: April 14, 2016
Dear Mr. Webb:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. J.D. Webb
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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160522
Device Name
White Pearl Preferred Angle Anterior Cervical Plate
Indications for Use (Describe)
The White Pearl Preferred Angle Anterior Cervical Plate 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 T1). 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 (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis,
- · failed previous fusion,
- · spinal stenosis
| 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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510(k) Summary: White Pearl Preferred Angle Anterior Cervical Plate
| Date Prepared | February 15, 2016 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC |
| 2703 Mockingbird Lane, Suite 102 | |
| Dallas, TX 75235 | |
| 214-395-0100 Tele | |
| email: rpace@osseus.com | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | White Pearl Preferred Angle Anterior Cervical Plate |
| Common Name | anterior cervical plate |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | ll |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Zimmer Trinica/Trinica Select Anterior Cervical Plate System (K132012) |
| Additional Predicate | |
| Devices | Spinal USA Slimpicity Anterior Cervical Plate System (K060025) |
| Synthes Anterior CSLP System (K000536) | |
| DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) | |
| Zimmer Optio-C Anterior Cervical System (K132894) | |
| Device Description | The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical |
| plates, locking caps, bone screws, and the instruments necessary to implant this | |
| specific system. All implant components are made from a titanium alloy (Ti-6Al- | |
| 4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to | |
| provide stabilization of the cervical vertebrae for various indications. The fixation | |
| construct consists of a cervical plate that is attached to the vertebral body of the | |
| cervical spine with self-tapping and/or self-drilling bone screws using an anterior | |
| approach. Bone screws are available for fixed angle or variable angle | |
| implantation. The White Pearl Preferred Angle Anterior Cervical Plate is | |
| intended to be removed after solid fusion has occurred. | |
| Materials | Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The White Pearl Preferred Angle Anterior Cervical Plate is substantially |
| equivalent to the predicate devices in terms of intended use, design, materials | |
| used, mechanical safety and performances. | |
| The White Pearl Preferred Angle Anterior Cervical Plate 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 T1). The system is indicated | |
| for use in the temporary stabilization of the anterior spine during the | |
| development of cervical spinal fusion in patients with: | |
| Indications for Use | 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) pseudarthrosis failed previous fusion spinal stenosis | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Static and dynamic compression testing per ASTM F1717 Static torsion testing per ASTM F1717 The results of these evaluations indicate that the White Pearl Preferred Angle | |
| Anterior Cervical Plate is substantially equivalent to the predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | The White Pearl Preferred Angle Anterior Cervical Plate is substantially |
| equivalent to the predicate devices listed above. This conclusion is | |
| based upon the devices' similarities in principles of operation, | |
| technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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