(155 days)
No reference devices were used in this submission
No
The document describes a physical implant (spacer system) for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for spinal fusion procedures for degenerative disc disease, treating tumors, and fractures, which are therapeutic interventions aimed at alleviating symptoms and restoring physiological function.
No
Explanation: The CONSTRUX Mini PEEK Spacer System is an implantable device used for spinal fusion and replacement, designed to provide structural support and restore biomechanical integrity. It is not used to diagnose a medical condition, but rather to treat one.
No
The device description clearly states that the device is comprised of physical implants manufactured from PEEK and Titanium, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System are implants designed for surgical procedures to fuse vertebrae in the spine. They are physical devices inserted into the body, not tests performed on samples outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, these devices fall under the category of implantable medical devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in 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 and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK 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.
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.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in 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 Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Cervical Stand Alone System
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in 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 Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Product codes
ODP, OVE, MQP
Device Description
CONSTRUX Mini PEEK Spacer System:
The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.
CONSTRUX Mini PEEK Ti Spacer System:
The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti 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.
Cervical Stand Alone System
The Cervical Stand Alone Spacer system is designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.
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)
PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
There have been no design changes made to CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants. The purpose of this 510(k) submission is to obtain clearance to use allograft bone comprised of cancellous and/or corticocancellous bone graft as a substitute to autograft bone. No mechanical testing was performed to help determine substantial equivalence.
PERFORMANCE DATA – Summary of Clinical Test Conducted for Determination of Substantial Equivalence
Published retrospective clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants was provided in support of this application. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130177, K133653, K132999, K101812, K121649
Reference Device(s)
No reference devices were used in this submission
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
Orthofix, Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K142152
Trade/Device Name: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, OVE, MQP Dated: December 10, 2014 Received: December 11, 2014
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. 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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142152
K142152 Page 1 of 2
Device Name CONSTRUX Mini PEEK Spacer System CONSTRUX Mini PEEK Ti Spacer System Cervical Stand Alone System
Indications for Use (Describe)
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with desc 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 and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK 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.
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.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in 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 Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Cervical Stand Alone System
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in 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 Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
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Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract shape that resembles a stylized letter "O" or a curved arrow. A small "®" symbol is located to the upper right of the "X" in "ORTHOFIX", indicating that the name is a registered trademark. The overall design is clean and professional, suggesting a corporate logo.
510(k) SUMMARY
PEEK Cervical Interbody Device
| 510(k) Owner Information
| Name: | Orthofix Inc. |
|---|---|
| Address: | 3451 Plano Parkway |
| Lewisville, TX 75056 | |
| Telephone Number: | |
| Fax Number: | |
| Email: | 214.937.2145 |
| 214-937-3322 | |
| nataliavolosen@orthofix.com | |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia Volosen |
| Senior Regulatory Affairs Specialist | |
| Date Prepared: | December 10, 2014 |
| Name of Device | |
| Trade Name / Proprietary | |
| Name: | CONSTRUX Mini PEEK Spacer System |
| CONSTRUX Mini PEEK Ti Spacer System | |
| Cervical Stand Alone System | |
| Common Name: | Intervertebral body fusion device |
| Spinal intervertebral body fixation orthosis | |
| Product Code: | ODP, MQP, OVE |
| Regulatory Classification: | Class II per 21 CFR § 888.3080 |
| Class II per 21 CFR § 888.3060 | |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K130177 - Medtronic ANATOMIC PEEK™ CERVICAL FUSION |
| SYSTEM, SE 9/23/2013 (primary predicate) | |
| K133653 - Medtronic ANATOMIC PEEK PTC Cervical Fusion | |
| System, SE 4/28/2014 (additional predicate) | |
| K132999 - Cervical Stand Alone System, SE 04/14/2014 (additional | |
| predicate) | |
| K101812 - CONSTRUX Mini PEEK Spacer System, SE 09/27/2010 | |
| (additional predicate) | |
| K121649 - CONSTRUX Mini PEEK Ti Spacer System, | |
| SE 11/29/2012 (additional predicate) | |
| No reference devices were used in this submission |
Reason for 510(k) Submission: Expanded Indications for Use
Device Description
CONSTRUX Mini PEEK Spacer System:
The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The
5
superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.
CONSTRUX Mini PEEK Ti Spacer System:
The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti 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.
Cervical Stand Alone System
The Cervical Stand Alone Spacer system is designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.
Intended Use / Indications for Use
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in 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 and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.q.: the Ascent™ or Ascent LE™ POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK 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.
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.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
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Image /page/6/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the right of the "X" in "ORTHOFIX".
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in 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 Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Cervical Stand Alone System
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in 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 Cervical Stand Alone System is used with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have underqone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System and Cervical Stand Alone Spacer System are similar to the predicate devices in terms of indication for use, intended use, design and materials.
There may be differences in implant foot print and size which will not introduce additional risk to the patients as these devices are currently being cleared for distribution. The addition of the allograft comprised of cancellous and/or corticocancellous bone graft to the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System and Cervical Stand Alone Spacer System indication do not raise new types of safety and effectiveness questions (risks) not seen before. The same risks occur in the subject CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System and Cervical Stand Alone Spacer System as in the predicate devices.
PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
There have been no design changes made to CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants. The purpose of this 510(k) submission is to obtain clearance to use allograft bone comprised of cancellous and/or corticocancellous bone graft as a substitute to autograft bone. No mechanical testing was performed to help determine substantial equivalence.
PERFORMANCE DATA – Summary of Clinical Test Conducted for Determination of Substantial Equivalence
Published retrospective clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants was provided in support of this application. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or
7
Image /page/7/Picture/0 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract shape. The registered trademark symbol is located to the right of the word.
corticocancellous bone graft) in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
Basis of Substantial Equivalence
The CONSTRUX Mini PEEK Spacer system, CONSTRUX Mini PEEK Ti Spacer system and Cervical Stand Alone system have the same intended use, similar indications for use, the similar technological characteristics and design, same materials and the same principles of operation as the to the Medtronic ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) and Medtronic ANATOMIC PEEK PTC Cervical Fusion System (K133653).
The minor differences between CONSTRUX Mini PEEK Spacer system, CONSTRUX Mini PEEK Ti Spacer system and Cervical Stand Alone system implant design and the Medtronic ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) and Medtronic ANATOMIC PEEK PTC Cervical Fusion System (K133653) predicates does not introduce any additional patient risk.
There have been no design changes made to CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants since their last 510(k) clearance. The purpose of this 510(k) submission is to obtain clearance to use allograft bone comprised of cancellous and/or corticocancellous bone graft as a substitute / addition to autograft bone.