(28 days)
Not Found
No
The summary describes a physical interbody fusion device made of PEEK and stainless steel, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an interbody fusion device intended for spinal fusion procedures in patients with degenerative disc disease, which is a medical treatment.
No
The device is an implantable interbody fusion device used in spinal fusion procedures, not for diagnosing medical conditions.
No
The device description clearly states the device is an implantable portion composed of PEEK and stainless steel, which are hardware components.
Based on the provided text, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The HAnano InterFuse® Modular Interbody is described as an implantable device made of PEEK, designed for spinal fusion procedures. It is surgically inserted into the body.
- Intended Use: The intended use clearly states it's for spinal fusion procedures in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description focuses on the physical characteristics of the implant and its surgical application, which are characteristic of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The HAnano InterFuse® Modular Interbody is intended to be used for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The HAnano InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous nonfusion surgery at the involved spinal level(s). The HAnano InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Product codes
MAX
Device Description
The HA™" InterFuse® Modular Interbody is a modular lumbar intervertebral body fusion device with an implantable portion composed of polyetheretherketone (PEEK), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. This device is designed to be implanted via a PLIF approach utilizing a minimally invasive surgical technique to restore collapsed/afflicted disc space. The device construct consists of an initial A module, any number of middle B modules to appropriately fill the interbody space, and a final C module in which each module interlocks with the adjacent module(s). These modules are inserted via a rail system in which a PEEK and stainless steel tail attached to each module extends beyond the disc space and allows the modules to be inserted in a sequential fashion. The PEEK portion of the tail can be detaches the entire rail and allows the modules to be progressed laterally in the disc space and repeated to construct the implant in an in situ fashion. The modules will be manufactured in several different size/lordotic options to appropriately accommodate patient pathologies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
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)
Performance Testing - Non-Clinical: There are no changes to material or geometric design of the implant itself, so a full performance characterization of the device was deemed not necessary. Any changes in material strength that resulted from the surface coating are evaluated through the adhesion testing provided by the contract manufacturer, Promimic.
Performance Testing - Clinical: Clinical testing was not applicable to support a substantial equivalence determination for the subject device.
Conclusion: Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
September 19, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Next OrthoSurgical % Chhavy Tep-Cullison Regulatory Affairs Specialist JALEX Medical 27865 Clemens Rd. Suite 3 Westlake, Ohio 44145
Re: K242509
Trade/Device Name: HA"("" InterFuse® Modular Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 22, 2024 Received: August 22, 2024
Dear Chhavy Tep-Cullison:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K242509
Device Name
HAnano InterFuse® Modular Interbody
Indications for Use (Describe)
The HAnano InterFuse® Modular Interbody is intended to be used for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The HAnano InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous nonfusion surgery at the involved spinal level(s). The HAnano InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
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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Image /page/4/Picture/1 description: The image shows the logo for Next Orthosurgical. The logo features a golden sphere with a silver ring around it, resembling a planet. To the right of the sphere, the word "NEXT" is written in gold, with the word "ORTHOSURGICAL" written in gray underneath it.
Special 510(k) Submission -HA""" InterFuse® Modular Interbody 510(k) Summary
510(k) Summary
| Applicant: | Next Orthosurgical
3270 Corporate View, Suite A
Vista, CA 92081 |
|------------------------------|------------------------------------------------------------------------------------------------|
| Date: | 09/09/2024 |
| Applicant Contact: | Misty Calkins
Sr. RA/QA Specialist
MCalkins@nextorthosurgical.com |
| Contact Person: | Chhavy Tep-Cullison
Regulatory Affairs Specialist, JALEX Medical |
| Contact Email: | ccullison@jalexmedical.com |
| Contact Telephone: | (440) 320-4338 |
| Contact Fax: | (440) 933-7839 |
| Regulation Number: | 21 CFR 888.3080 |
| Classification Product Code: | MAX |
| Device Trade Name: | HA nano InterFuse® Modular Interbody |
| Common Name: | Intervertebral body fusion device |
| Device Classification Name: | Intervertebral fusion device with bone graft, lumbar |
| Device Class: | II |
| Reviewing Panel: | Orthopedic |
| Primary Predicate Device: | K091988 – InterFuse® Intervertebral Body Fusion Device |
| Additional Predicates: | K222561 – Align Intervertebral Body Fusion Device
K201614 - AxTiHA™ Stand-Alone ALIF System |
Device Description:
The HA™" InterFuse® Modular Interbody is a modular lumbar intervertebral body fusion device with an implantable portion composed of polyetheretherketone (PEEK), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. This device is designed to be implanted via a PLIF approach utilizing a minimally invasive surgical technique to restore collapsed/afflicted disc space. The device construct consists of an initial A module, any number of middle B modules to appropriately fill the interbody space, and a final C module in which each module interlocks with the adjacent module(s). These modules are inserted via a rail system in which a PEEK and stainless steel tail attached to each module extends beyond the disc space and allows the modules to be inserted in a sequential fashion. The PEEK portion of the tail can be detaches the entire rail and allows the modules to be progressed laterally in the disc space and repeated to construct the implant in an in situ
5
Image /page/5/Picture/1 description: The image contains the logo for Next Orthosurgical. The logo features a golden sphere with a silver ring around it on the left side. To the right of the sphere, the word "NEXT" is written in gold, and below it, the word "ORTHOSURGICAL" is written in gray.
Special 510(k) Submission -HA"ano InterFuse® Modular Interbody 510(k) Summary
fashion. The modules will be manufactured in several different size/lordotic options to appropriately accommodate patient pathologies.
Indications for Use and Intended Use:
The HA™" InterFuse® Modular Interbody is intended to be used for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). The HA™® InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The HA™® InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Description of Modifications:
The purpose of this submission is for Next Orthosurgical to obtain clearance for the HA""" InterFuse® Modular Interbody line extension, which includes an updated surface treatment of the legally marketed previous generation of the device, the Intervertebral Body Fusion Device (K091988). HA™ surface treatment from Promimic AB will be applied to the entire surface of the PEEK implants. This product will aim to optimize both the mechanical properties of PEEK interbodies for lumbar fusion as well as the bone integrating qualities of HA that raw PEEK would not previously exhibit. There are no changes to material or sterilization parameters. The substrate material, articulating surface roughness, porous coating and bone-facing geometry are identical to the InterFuse® Intervertebral Body Fusion Device.
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Image /page/6/Picture/1 description: The image shows the logo for Next Orthosurgical. The logo features a golden sphere with a silver ring around it on the left side. On the right side of the logo, the word "NEXT" is written in gold, and below it, the word "ORTHOSURGICAL" is written in a smaller font.
Special 510(k) Submission -HA""" InterFuse® Modular Interbody 510(k) Summary
Summary of Technological Characteristics:
The subject HA""" InterFuse® Modular Interbody has the same intended use and indications for use as the predicate system. The technological characteristics of the subject system are similar to those of the predicate, and the information provided herein demonstrates that any differences do not impact safety or effectiveness.
| Item | Subject Device | Primary Predicate | Equivalence |
|---|---|---|---|
| HAnano InterFuse® Modular Interbody | InterFuse® Intervertebral Body Fusion Device (K091988) | ||
| Device | Intervertebral Fusion Device with Bone Graft, Lumbar | Intervertebral Fusion Device with Bone Graft, Lumbar | Equivalent |
| Regulation Description | Intervertebral body fusion device | Intervertebral body fusion device | Equivalent |
| Regulation Number | 21 CFR 888.3080 | 21 CFR 888.3080 | Equivalent |
| Product Code | MAX | MAX | Equivalent |
| Material | PEEK per ASTM F2026 | ||
| HAnano surface coating | PEEK per ASTM F2026 | Substantially Equivalent | |
| Manufacturing | Traditional Molding and Manufacturing | ||
| Surface treatment with HAnano | Traditional Molding and Machining | Substantially Equivalent | |
| Sterilization | Sterile | Sterile | Equivalent |
| Implantation Level | L2 to S1 | L2 to S1 | Equivalent |
Performance Testing - Non-Clinical:
There are no changes to material or geometric design of the implant itself, so a full performance characterization of the device was deemed not necessary. Any changes in material strength that resulted from the surface coating are evaluated through the adhesion testing provided by the contract manufacturer, Promimic.
Performance Testing - Clinical:
Clinical testing was not applicable to support a substantial equivalence determination for the subject device.
Conclusion
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.