(30 days)
Not Found
No
The document describes a physical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "Spacer System" for spinal fusion procedures in patients with degenerative disc disease, facilitating vertebral fusion, maintaining disc height, and stabilizing vertebrae, all of which are therapeutic functions.
No
The CONSTRUX® Mini PTC Spacer System is an implantable device used in spinal fusion procedures to facilitate vertebral fusion, maintain disc height, and prevent vertebral collapse. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is comprised of physical implants made of PEEK and Titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The CONSTRUX® Mini PTC Spacer System is a surgical implant designed to be placed directly into the cervical spine to facilitate spinal fusion. It is a physical device used within the body, not for testing samples outside the body.
The description clearly indicates it's a physical implant for surgical use in the spine.
N/A
Intended Use / Indications for Use
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.
Product codes
ODP
Device Description
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium endplates have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. The CONSTRUX Mini PTC spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
The CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-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
No new mechanical testing was performed for the CONSTRUX Mini PTC Spacer System because the 10° lordosis does not create a new worst case construct for mechanical performance.
Key Metrics
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.
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Image /page/0/Picture/0 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 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.
October 14, 2020
Orthofix Inc. Natalia Volosen Regulatory Affairs Principal 3451 Plano Parkway Lewisville, Texas 75056
Re: K202666
Trade/Device Name: CONSTRUX® Mini PTC Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: September 11, 2020 Received: September 14, 2020
Dear Ms. Volosen:
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
1
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 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,
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
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Indications for Use
510(k) Number (if known) K202666
Device Name CONSTRUX® Mini PTC Spacer System
Indications for Use (Describe)
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.
| 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
| Device Trade Name: | CONSTRUX® Mini PTC Spacer System |
|---|---|
| Manufacturer: | Orthofix Inc. |
| 3451 Plano Parkway | |
| Lewisville, TX 75056, USA | |
| Phone: (214) 937-2145 | |
| Fax: (214) 937-3322 | |
| Contact Person: | Ms. Natalia Volosen |
| Regulatory Affairs Principal | |
| nataliavolosen@orthofix.com | |
| Date Prepared: | September 10, 2020 |
| Registration Number: | 2183449 |
| Product Code: | ODP |
| Classifications: | Class II - 21 CFR §888.3080, Intervertebral body fusion |
| device | |
| Primary Predicate: | |
| Additional Predicate: | K200052 – CONSTRUX™ Mini PTC Spacer System, |
| SE 4/9/2020 | |
| K193359 – SureMAX™ Family of Cervical Spacers, | |
| SE 1/3/2020 |
Reason for the 510(k) Submission: Addition of 10° Lordotic interbody devices
Device Description:
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium endplates have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. The CONSTRUX Mini PTC spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
The CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.
Indications for Use and Intended Use:
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of
4
discogenic origin with deqeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.
Performance Testing Summary:
No new mechanical testing was performed for the CONSTRUX Mini PTC Spacer System because the 10° lordosis does not create a new worst case construct for mechanical performance.
Substantial Equivalence:
The subject device is substantially equivalent to the CONSTRUX Mini PTC Spacer System (K200052) primary predicate and SureMAX™ Family of Cervical Spacers (K193359) additional predicate with respect to indications, design, materials, function, and performance.
Conclusion:
CONSTRUX Mini PTC Spacer System have the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device CONSTRUX Mini PTC Spacer System (K200052) and SureMAX™ Family of Cervical Spacers (K193359).