(29 days)
No
The document describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a PEEK spacer system used for spinal fusion and partial vertebral body replacement to treat degenerative disc disease, tumors, and fractures, which are therapeutic interventions.
No
This device is a spinal implant (spacer system) used for fusion procedures and vertebral body replacement, not for diagnosing medical conditions.
No
The device description explicitly states the device is comprised of implants manufactured from PEEK and titanium markers, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The CONSTRUX Mini PEEK Spacer System is a physical implant made of PEEK and titanium markers. It is surgically placed within the spine.
- Intended Use: The intended use is for spinal fusion procedures and partial vertebral body replacement, which are surgical interventions, not diagnostic tests performed on samples.
The device is a medical device used for treatment and structural support within the body, not for diagnosing conditions using in vitro methods.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK 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 PEEK Spacer System is intended for use with autograft 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.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft and supplemental fixation system.
Product codes
ODP, MQP
Device Description
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markers as described by ASTM F67. The implants are available in multiple sizes to accommodate various patient anatomies. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.
The CONSTRUX Mini PEEK Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PEEK Spacer System must be used with a supplemental fixation system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), thoracolumbar spine (T1-L5)
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)
The modified CONSTRUX Mini PEEK spacer was evaluated via mechanical testing per ASTM F2077 (including static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion) and ASTM F2267 (subsidence). The results demonstrated the performance of the modified cervical spacer is substantially equivalent to the predicate device.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 29, 2020
Orthofix Inc. Ms. Natalia Volosen Regulatory Affairs Principal 3451 Plano Parkway Lewisville, Texas 75056
Re: K202949
Trade/Device Name: CONSTRUX Mini PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MQP Dated: September 29, 2020 Received: September 30, 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.
1
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 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 L. 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) K202949
Device Name CONSTRUX Mini PEEK Spacer System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK 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 PEEK Spacer System is intended for use with autograft 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.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Minn PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft and supplemental fixation system.
| 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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3
510(k) Summary
Device Trade Name: CONSTRUX Mini PEEK 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 29, 2020
Registration Number: 2183449
Product Code: ODP, MQP
- Class II 21 CFR §888.3080, Intervertebral body fusion device Classifications: Class II - 21 CFR §888.3060. Spinal vertebral body replacement device
Primary Predicate: K150619 - CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, SE 9/11/2015 Additional Predicate: K193359 - SureMAX™ Family of Cervical Spacers, SE 1/3/2020
Reason for the 510(k) Submission: Product Line Extension
Device Description:
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markers as described by ASTM F67. The implants are available in multiple sizes to accommodate various patient anatomies. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.
The CONSTRUX Mini PEEK Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PEEK Spacer System must be used with a supplemental fixation system.
Indications for Use and Intended Use:
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK 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.
4
The CONSTRUX Mini PEEK 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.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft and supplemental fixation system.
Performance Testing Summary:
The modified CONSTRUX Mini PEEK spacer was evaluated via mechanical testing per ASTM F2077 (including static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion) and ASTM F2267 (subsidence). The results demonstrated the performance of the modified cervical spacer is substantially equivalent to the predicate device.
Substantial Equivalence:
The subject device is substantially equivalent to the CONSTRUX Mini PEEK Spacer System (K150619) primary predicate and SureMAX™ Family of Cervical Spacers (K193359) additional predicate with respect to indications, design, materials, function, and performance.
Conclusion:
CONSTRUX Mini PEEK 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 PEEK Spacer System (K150619) and SureMAXTM Family of Cervical Spacers (K193359).