(62 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not algorithm performance evaluations.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities, addressing conditions like fractures, deformities, and degenerative diseases, which are therapeutic interventions.
No
The device is described as an immobilization and stabilization system for spinal segments, intended as an adjunct to fusion for various instabilities and conditions. It is a surgical implant designed to provide physical support, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description explicitly states that the system consists of physical components like longitudinal members, anchors, interconnecting devices, and fasteners, which are hardware implants.
No, 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 provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system designed to immobilize and stabilize the spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the Saxxony™ Posterior Cervical Thoracic System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Saxxony™ Posterior Cervical Thoracic System is intended to immobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments as an adjunct to fusion for the following acute and chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Saxxony™ Posterior Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Saxxony™ Posterior Cervical Thoracic System rods may be connected to cervicothoracic or thoracolumbar stabilization systems ranging in diameter from 3.5mm, using corresponding rod to rod connectors and/or transition rods.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
SaxxonyTM Posterior Cervical Thoracic System consists of longitudinal members, anchors, interconnecting devices and fasteners in a variety of sizes to accommodate differing anatomic requirements. The implants are sold non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (C1 to C7) and thoracic (T1 to T3) spinal segments, cervical spine
Indicated Patient Age Range
Not Found
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 Saxxony™ Posterior Cervical Thoracic System constructs included static and dynamic compression bending and static torsion according to ASTM F1717.
The mechanical test results demonstrate that Saxxony™ Posterior Cervical Thoracic 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.
K150552, K070638, K994187, K945700, K142838
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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November 13, 2018
Nexxt Spine, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026
Re: K182508
Trade/Device Name: Saxxony™ Posterior Cervical Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: September 10, 2018 Received: September 12, 2018
Dear Dr. Warden:
We have reviewed vour 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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
SaxxonyTM Posterior Cervical Thoracic System
Indications for Use (Describe)
The Saxxony™ Posterior Cervical Thoracic System is intended to immobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments as an adjunct to fusion for the following acute and chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Saxxony™ Posterior Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Saxxony™ Posterior Cervical Thoracic System rods may be connected to cervicothoracic or thoracolumbar stabilization systems ranging in diameter from 3.5mm, using corresponding rod to rod connectors and/or transition rods.
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
| Date: | 10 September 2018 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Contact Person: | 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: | SaxxonyTM Posterior Cervical Thoracic System |
| Common Name: | Posterior cervical-thoracic system |
| Device Classification | Unclassified, Pre-amendment Device |
| Classification Name; | |
| Regulation; Device | |
| Product Code: | Orthosis, Cervical Pedicle Screw Spine Fixation; Unclassified, Pre- |
| amendment; NKG | |
| Appliance, Fixation, Spinal Interlaminal: 888.3050; KWP | |
| Device Description: | SaxxonyTM Posterior Cervical Thoracic System consists of longitudinal |
| members, anchors, interconnecting devices and fasteners in a variety of | |
| sizes to accommodate differing anatomic requirements. The implants are | |
| sold non-sterile. | |
| Intended Use: | The SaxxonyTM Posterior Cervical Thoracic System is intended to |
| immobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal | |
| segments as an adjunct to fusion for the treatment of the following acute | |
| and chronic instabilities: traumatic spinal fractures and/or traumatic | |
| dislocations; instability or deformity; failed previous fusions (e.g. | |
| pseudarthrosis); tumors involving the cervical/thoracic spine; and | |
| degenerative disease, including intractable radiculopathy and/or | |
| myelopathy, neck and/or arm pain of discogenic origin as confirmed by | |
| radiographic studies, and degenerative disease of the facets with instability. | |
| The SaxxonyTM Posterior Cervical Thoracic System is also intended to | |
| restore the integrity of the spinal column even in the absence of fusion for a | |
| limited time period in patients with advanced stage tumors involving the | |
| cervical spine in whom life expectancy is of insufficient duration to permit | |
| achievement of fusion. | |
| In order to achieve additional levels of fixation, the SaxxonyTM Posterior | |
| Cervical Thoracic System rods may be connected to cervicothoracic or | |
| thoracolumbar stabilization systems ranging in diameter from 3.5mm to | |
| 6.5mm, using corresponding rod to rod connectors and/or transition rods. | |
| Materials: | The SaxxonyTM Posterior Cervical Thoracic System is manufactured from |
| Ti-6Al-4V ELI titanium alloy (ASTM F136) or cobalt chrome (ASTM F1537). | |
| Primary Predicate | ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal Systems |
| (Globus Medical, Incorporated, K150552) | |
| Additional Predicates: | Atoll Cervico-Thoracic System (Theken Spine – K070638), CerviFix |
| StarLock System (Synthes USA – K994187), Synthes (USA) Anterior | |
| Cervical Vertebrae Plate System (Synthes (USA) – K945700), Synapse | |
| OCT System (Synthes USA Products LLC ) – K142838) | |
| Performance Data: | Mechanical testing of worst case Saxxony™ Posterior Cervical Thoracic |
| System constructs included static and dynamic compression bending and | |
| static torsion according to ASTM F1717. | |
| The mechanical test results demonstrate that Saxxony™ Posterior Cervical | |
| Thoracic System performance is substantially equivalent to the predicate | |
| devices. | |
| Technological | |
| Characteristics: | The Saxxony™ Posterior Cervical Thoracic System possesses similar |
| technological characteristics as the predicate devices. These include: | |
| • performance (as described above), | |
| • basic design (rod, screw, hook and connectors configuration), | |
| • material (titanium and cobalt chrome alloys), and | |
| • sizes (dimensions are comparable to those offered by the predicate | |
| systems). | |
| Therefore the fundamental scientific technology of the Saxxony™ Posterior | |
| Cervical Thoracic System is the same as previously cleared devices. | |
| Conclusion: | The Saxxony™ Posterior Cervical Thoracic System possesses the same |
| intended use and technological characteristics as the predicate devices. | |
| Therefore the Saxxony™ Posterior Cervical Thoracic System is | |
| substantially equivalent for its intended use. |
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