(99 days)
The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacrollitis and sacroiliac joint disruptions, to augment immobilization of the sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, nonacute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The Entasis 3D Dual-Lead Sacroiliac Implant System consists of additive and machined dual-lead sacroiliac screws and optional washers to aid in load bearing and conformity to patient anatomy. The Entasis 3D Dual-Lead Sacroiliac Implant System is manufactured from additive titanium alloy (Ti-6Al-4V) per ASTM F3001 or machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. These screws are available in lengths from 30 mm to 110 mm and diameters of Ø7 mm to Ø14.5 mm.
The provided text describes a 510(k) premarket notification for a medical device called the "Entasis 3D Dual-Lead Sacroiliac Implant System." This document is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared predicate devices.
Crucially, the provided text does not contain any information about the acceptance criteria, study methodologies, or performance results related to an AI/ML algorithm or software as a medical device (SaMD). It describes a physical implant system and its mechanical testing for structural integrity.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving an AI/ML device meets them, as the input material is irrelevant to such a request.
This document focuses on:
- Device Description: A sacroiliac implant system made of titanium alloy for joint fusion.
- Intended Use: Sacroiliac joint fusion for various conditions including degenerative sacroiliitis, joint disruptions, sacropelvic fixation augmentation, and fractures.
- Technological Characteristics: Comparison to predicate devices, highlighting similarities in indications, materials, structural support, surgical approach, sizes, and design features.
- Performance Data: Non-clinical (mechanical) testing of the implant system itself (Static Torsion, Driving Torsion, Pullout, Static & Dynamic Cantilever Bending).
- Conclusion: The device is substantially equivalent to predicate devices based on technological characteristics and mechanical performance.
If you have a document related to an AI/ML device, please provide that text, and I would be happy to analyze it according to your requested criteria.
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March 21, 2023
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CoreLink. LLC Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Dr. Colorado Springs, Colorado 80918
Re: K223708
Trade/Device Name: Entasis 3D Dual-Lead Sacroiliac Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: December 9, 2022 Received: December 12, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
Colin O'neill -S
Colin O'Neill, MBE 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) K223708
Device Name Entasis 3D Dual-Lead Sacroiliac Implant System
Indications for Use (Describe)
The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions, to augment immobilization of the sacrolliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, nonacute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
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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K223708 - 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.comImage: Empirical Technologies Logo |
| Date Summary was Prepared: | December 9, 2022 |
| Trade or Proprietary Name: | Entasis 3D Dual-Lead Sacroiliac Implant System |
| Device Classification Name: | Sacroiliac Joint Fixation |
| Classification & Regulation #: | Class II per 21 CFR §888.3040 |
| Product Code: | OUR, HWC |
| Classification Panel: | Orthopedic Devices – Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Entasis 3D Dual-Lead Sacroiliac Implant System consists of additive and machined dual-lead sacroiliac screws and optional washers to aid in load bearing and conformity to patient anatomy. The Entasis 3D Dual-Lead Sacroiliac Implant System is manufactured from additive titanium alloy (Ti-6Al-4V) per ASTM F3001 or machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. These screws are available in lengths from 30 mm to 110 mm and diameters of Ø7 mm to Ø14.5 mm.
INDICATIONS FOR USE
The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
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 subject shares the following same characteristics as the predicates:
- Indications for Use
- Materials of Manufacturer ●
- Structural Support Mechanism ●
- Surgical Approach
- Sizes and Design Features ●
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Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K212903 | SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | OUR, HWC | Primary |
| K222605 | iFuse TORQ Implant System | SI-Bone, Inc. | OUR, HWC, OLO | Additional |
| K152237 | Entasis Dual-Lead Sacroiliac Implant System | CoreLink, LLC | OUR | Additional |
| K220195 | iFuse Bedrock Granite Implant System | SI-Bone, Inc. | OUR, NKB, OLO | Additional |
Performance Data
The Entasis 3D Dual-Lead Sacroiliac Implant System has been tested in the following test modes:
- Static Torsion per ASMT F3574
- Driving Torsion per ASTM F3574 ●
- Pullout per ASTM F3574 ●
- Static & Dynamic Cantilever Bending per ASTM F3547 .
The results of this non-clinical testing show that the strength of the Entasis 3D Dual-Lead Sacroiliac Implant 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 Entasis 3D Dual-Lead Sacroiliac Implant System is substantially equivalent to the predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.