(126 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is indicated for use in treating degenerative disc disease, tumors, or trauma/fracture, and aims to restore height and stabilize the spine, which are therapeutic functions.
No
The device is described as a collection of additively manufactured spacers for spinal fusion and vertebral body replacement, which are treatment devices, not diagnostic devices.
No
The device description clearly states that the Matrixx™ System is a collection of "additively manufactured spacers" which are physical implants for surgical stabilization of the spine. This indicates a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Matrixx™ System is described as a collection of additively manufactured spacers intended for surgical implantation in the spine to provide stabilization and facilitate fusion. It is a physical implant used directly within the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological specimens, diagnostic testing, or providing information about a patient's health based on laboratory results.
Therefore, the Matrixx™ System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral fusion device, the Matrixx™ System open devices are indicated for use at up to two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
When used as a lumbar intervertebral fusion device, the Matrixx® System open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Matrixx™ System lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft and or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
When used as a vertebral body replacement device, the Matrixx™ System open and solid devices are indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX, MQP
Device Description
The Matrixx™ System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700μm.
The inferior/superior aspects of the Matrixx™ open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the Matrixx™ solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C2-T1; lumbar spine, from L2-S1; 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)
Mechanical testing of worst case Matrixx™ System devices included static and dynamic compression, static and dynamic compression shear and static torsion according to ASTM F2077. In addition, the subsidence properties were evaluated according to ASTM F2267 and expulsion according to the ASTM draft standard. The manufactured surface was evaluated according to ASTM F1978.
The mechanical test results demonstrate that Matrixx™ System performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nexxt Spine, LLC % Karen Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026-2141 August 22, 2017
Re: K171140
Trade/Device Name: Matrixx™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, MQP Dated: July 21, 2017 Received: July 24, 2017
Dear Dr. Warden:
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 (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (DICE) 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. 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
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 (DICE) 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171140
Device Name MatrixxTM System
Indications for Use (Describe)
When used as a cervical intervertebral fusion device, the Matrixx™ System open devices are indicated for use at up to two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
When used as a lumbar intervertebral fusion device, the Matrixx® System open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Matrixx™ System lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft and or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
When used as a vertebral body replacement device, the Matrixx™ System open and solid devices are indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | 17 April 2017 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | Matrixx™ System |
| Common Name: | Spacer system |
| Device Classification: | Class II |
| Regulation Names, | |
| Regulation Numbers, | |
| Product Codes: | Spinal vertebral body replacement device, 888.3060, MQP |
| Intervertebral fusion device with bone graft, 888.3080, lumbar/cervical, | |
| MAX/ODP | |
| Device Description: | The Matrixx™ System is a collection of additively manufactured spacers for |
| cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic | |
| shape of these implants is a structural column to provide surgical | |
| stabilization of the spine. Each device comprises an external structural | |
| frame having a roughened surface (~7μm). The intervening geometric | |
| lattices have pores 300-700μm. | |
| The inferior/superior aspects of the Matrixx™ open devices incorporate a | |
| large vertical cavity which can be packed with bone graft material. The | |
| inferior/superior aspects of the Matrixx™ solid devices are closed and do | |
| not permit the packing of bone graft within the implant. The solid devices | |
| are only to be used for partial vertebral body replacement. The open and | |
| solid devices are available in an assortment of height, length, width and | |
| lordotic angulation combinations to accommodate the individual anatomic | |
| and clinical circumstances of each patient. | |
| Indications for Use: | When used as a cervical intervertebral fusion device, the Matrixx™ System |
| open devices are indicated for use at up to two contiguous levels in the | |
| cervical spine, from C2-T1, in skeletally mature patients who have had six | |
| weeks of non-operative treatment for the treatment of degenerative disc | |
| disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as | |
| neck pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies. The device is intended for use with | |
| autograft and/or allograft comprised of cancellous and/or corticocancellous | |
| bone graft and with supplemental fixation. | |
| When used as a lumbar intervertebral fusion device, the Matrixx™ System | |
| open devices are indicated for use at one or two contiguous levels in the | |
| lumbar spine, from L2-S1, in skeletally mature patients who have had six | |
| months of non-operative treatment for the treatment of degenerative disc | |
| disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as | |
| back pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies. Additionally, the Matrixx™ System lumbar | |
| implants can be used as an adjunct to fusion in patients diagnosed with | |
| degenerative scoliosis. The device is intended for use with autograft and/or | |
| allograft comprised of cancellous and/or corticocancellous bone graft and | |
| with supplemental fixation. | |
| When used as a vertebral body replacement device, the Matrixx™ System | |
| open and solid devices are 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 or | |
| trauma/fracture in order to achieve anterior decompression of the spinal | |
| cord and neural tissues, and to restore the height of a collapsed vertebral | |
| body. The device is intended for use with autograft or allograft and with | |
| supplemental internal fixation. | |
| Materials: | Matrixx™ System implants are manufactured from Ti-6Al-4V ELI titanium |
| alloy (ASTM F3001). | |
| Primary Predicate: | Primary: Cascadia Interbody System (K2M Inc. - K160125) |
| Additional Predicates: | Additional: Honour System (Nexxt Spine, LLC – K120345), Lumbar I/F |
| Cage (DePuy Spine – P960025) | |
| Performance Data: | Mechanical testing of worst case Matrixx™ System devices included static |
| and dynamic compression, static and dynamic compression shear and | |
| static torsion according to ASTM F2077. In addition, the subsidence | |
| properties were evaluated according to ASTM F2267 and expulsion | |
| according to the ASTM draft standard. The manufactured surface was | |
| evaluated according to ASTM F1978. | |
| The mechanical test results demonstrate that Matrixx™ System | |
| performance is substantially equivalent to the predicate devices. | |
| Technological Characteristics: | The Matrixx™ System possesses the same technological characteristics as |
| one or more of the predicate devices. These include: intended use (as described above) basic design (additively manufactured structure) material (titanium alloy) sizes (dimensions are comparable to those offered by the predicate systems) and The Matrixx™ System is the same as previously cleared devices. | |
| Conclusion: | The Matrixx™ System possesses the same intended use and technological |
| characteristics as the predicate devices. Therefore Matrixx™ System is | |
| substantially equivalent for its intended use. |
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