(196 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities and conditions of the cervical and thoracic spine, which aligns with the definition of a therapeutic device.
No
The device is described as a modular, posterior system used for surgical stabilization and fixation of the spine, intended to provide immobilization and restore integrity of the spinal column. There is no mention of diagnostic capabilities, only therapeutic and supportive functions.
No
The device description explicitly states that neon3™ is a modular, posterior system with physical components including longitudinal members, anchors, and interconnection devices, indicating it is a hardware-based medical device.
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: The description of neon3™ clearly states it is a "modular, posterior system used for the surgical stabilization and fixation of the cervical and thoracic regions of the spine." This describes a surgical implant, not a device that analyzes samples outside the body.
- Intended Use: The intended use describes the conditions the device is used to treat by providing structural support and stabilization within the body. It does not involve analyzing biological samples.
Therefore, based on the provided information, neon3™ is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): 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.
neon3TM 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.
Product codes
NKG, KWP
Device Description
neon 3™ is a modular, posterior system used for the surgical stabilization and fixation of the cervical and thoracic regions of the spine. The system components include longitudinal members, anchors and interconnection devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C1 to C7) and the thoracic spine (T1 to T3)
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 neon3™ constructs included static and dynamic compression bending and torsion according to ASTM F1717. Tulip/shank dissociation testing was performed on the worst case neon3™ screws.
Published literature and the mechanical test results demonstrate that neon3™ performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K070638, K113346, K151031, K990965, K030377, K011966
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2015
ulrich GmbH & Company KG % Mr. Hans Stover President and CEO ulrich medical USA, Incorporated 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K150650
Trade/Device Name: neon3TM Regulatory Class: Unclassified Product Code: NKG, KWP Dated: August 21, 2015 Received: August 24, 2015
Dear Mr. Stover:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (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.
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Page 2 - Mr. Hans Stover
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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150650
Device Name neon3TM
Indications for Use (Describe)
neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): 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.
neon?™ 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.
| 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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Section 8 – 510(k) Summary
Image /page/3/Picture/1 description: The image contains the logo for Ulrich medical USA. The logo features a stylized "U" with a black square to the left of the letter. Below the word "Ulrich" is the text "medical USA" in a smaller font size.
| Date: | 10 March 2015 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KG |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | |
| Phone: +49 (0) 731-9654-1304 | |
| Fax: +49 (0) 731-9654-2802 | |
| Contact Person: | Hans Stover |
| ulrich medical USA, Inc. | |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Proposed Trade Name: | neon3 тм |
| Common Name: | Posterior cervicothoracic system |
| Device Classification: | Posterior, Cervical Pedicle Screw Spine Fixation |
| Orthopaedic and Rehabilitation Devices Panel | |
| Unclassified; Pre-Amendment Device | |
| Product Code: NKG | |
| Appliance, Fixation, Spinal Interlaminal | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Class 2 per 21 CFR 888.3050 | |
| Product Code: KWP | |
| Device Description: | neon 3™ is a modular, posterior system used for the surgical stabilization |
| and fixation of the cervical and thoracic regions of the spine. The system | |
| components include longitudinal members, anchors and interconnection | |
| devices. | |
| Indications for Use: | neon3™ is intended to provide immobilization and stabilization of spinal |
| segments as an adjunct to fusion for the following acute and chronic | |
| instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to | |
| T3): 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. | |
| neon 3TM 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. | |
| Materials: | neon 3™ components are manufactured from Grade 2 titanium (ASTM F67), |
| Ti-6Al-4V titanium alloy (ASTM F136) or Cobalt Chrome (ASTM F1537) | |
| Primary Predicate: | Synapse Occipital-Cervical-Thoracic (OCT) System (Synthes, K142838) |
| Reference Devices: | Atoll Cervico-Thoracic System (Integra [orig. Theken Spine] – K070638), |
| neon™ (ulrich medical – K113346), | |
| Virage OCT Spinal Fixation System (Zimmer Spine Inc. – K151031) and | |
| CerviFix® System (Synthes Spine – K990965, K030377 and K011966) | |
| Performance Data: | Mechanical testing of worst case neon3™ constructs included static and |
| dynamic compression bending and torsion according to ASTM F1717. | |
| Tulip/shank dissociation testing was performed on the worst case neon3™ | |
| screws. |
Published literature and the mechanical test results demonstrate that neon3™
performance is substantially equivalent to the predicate devices. |
| Technological
Characteristics: | neon3™ possesses the same technological characteristics as one or more
of the predicate devices. These include:
intended use (as described above) basic design (rod-based having screw and/or hook anchors), material (titanium / titanium alloy), sizes (dimensions are comparable to those offered by the predicate systems) and The fundamental scientific technology of neon3™ is the same as previously cleared devices. |
| Conclusion: | neon3™ possesses the same intended use and technological
characteristics as the predicate devices. Therefore neon3™ is substantially
equivalent for its intended use. |
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