(49 days)
The CoreLink NextGen Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
The NextGen Pedicle Screw System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of traditional pedicle screw assemblies or modular tulip heads with modular screw shanks with extended tab reduction tulip or closed head tulip options, cross-link connectors, set screws, and spinal rods. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. Implants in the NextGen Pedicle Screw System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.
The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria.
The document is a 510(k) premarket notification for a medical device called the "NextGen Pedicle Screw System." This system is described as a Thoracolumbosacral Pedicle Screw System, which provides immobilization and stabilization of spinal segments. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, materials, component selection, component sizes, biocompatibility, and non-clinical mechanical performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the provided text is about a physical medical implant device and its mechanical testing, not an AI or software device.
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August 9, 2022
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CoreLink, LLC % Nathan Wright Engineer and Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K221776
Trade/Device Name: NextGen Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 17, 2022 Received: June 21, 2022
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
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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 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 mediation-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,
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221776
Device Name NextGen Pedicle Screw System
Indications for Use (Describe)
The CoreLink NextGen Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric edicle
screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Type of Use (Select one or both, as applicable) � Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Submitter's Name: | CoreLink, LLC | |
|---|---|---|
| Submitter's Address: | 2072 Fenton Logistics ParkSt. Louis, Missouri 63026 | |
| Submitter's Telephone: | 888-349-7808 | |
| Contact Person: | Nathan Wright MSEmpirical Technologies1-719-351-0248nwright@empiricaltech.com | Image: Empirical Technologies logo |
| Date Summary was Prepared: | June 17, 2022 | |
| Trade or Proprietary Name: | NextGen Pedicle Screw System | |
| Common or Usual Name: | Thoracolumbosacral Pedicle Screw System | |
| Classification: | Class II per 21 CFR §888.3070 | |
| Product Code: | NKB | |
| Classification Panel: | Orthopedic - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NextGen Pedicle Screw System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of traditional pedicle screw assemblies or modular tulip heads with modular screw shanks with extended tab reduction tulip or closed head tulip options, cross-link connectors, set screws, and spinal rods. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.
Implants in the NextGen Pedicle Screw System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.
INDICATIONS FOR USE
The CoreLink NextGen Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
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. The subject device is the same or similar to the predicate devices in the following ways:
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● Indications for Use
- Materials
- Component Selection ●
- Component Sizes .
- . Biocompatibility
The differences in modular tulip head components do not affect the safety and efficacy of the subject device since mechanical testing was conducted to show substantial equivalence in device bench testing performance.
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K210539 | CoreLink Midline Fixation System | CoreLink, LLC | NKB | Primary |
| K211323 | ASTRA Spine System | SpineCraft, LLC | NKB, KWP, KWQ | Additional |
| K180179 | Firebird Spinal Fixation System | Orthofix Inc. | NKB | Additional |
PERFORMANCE DATA
The NextGen Pedicle Screw System has been tested in the following test modes:
- Static compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717
- Dynamic compression bending per ASTM F1717
- Axial grip per ASTM F1798
- Torsion grip per ASTM F1798
- . Tulip shank disassociation per ASTM F1798
The results of this non-clinical testing show that the strength of the NextGen Pedicle Screw 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 NextGen Pedicle Screw System is substantially equivalent to the predicate device.
N/A