(57 days)
Not Found
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 and restore the integrity of the spinal column, which are therapeutic functions for treating certain medical conditions.
No
The device is described as a spinal fixation system intended for immobilization and restoration of spinal integrity, which are therapeutic functions, not diagnostic ones.
No
The device description clearly lists physical components such as longitudinal rods, screw anchors, and interconnecting devices, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to provide immobilization and restore spinal column integrity. This is a therapeutic and structural function within the body.
- Device Description: The device components are described as surgical implants (rods, screws, connectors) used for fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support and stabilization.
N/A
Intended Use / Indications for Use
Cortium is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fraumatic 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.
Cortium 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, Cortium can also be connected to Momentum via transition rods or connectors. Please refer to the Momentum Instructions for Use for a list of indications for use.
Product codes
NKG
Device Description
The Cortium system is a posterior occipital-cervical-thoracic (OCT) spinal fixation system. The system components include longitudinal rods, screw anchors, and interconnecting devices such as anchor-to-rod and rod-to-rod connectors, rod-to-rod crosslinks and screw-to-screw crosslinks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3)
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 Cortium constructs included ASTM F1717 static and dynamic compression bending and static torsion, F1798 tulip pull-off testing and F2706 static and dynamic compression bending and static and dynamic torsion. The mechanical test results demonstrate that Cortium performance is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
neon3™ (ulrich GmbH & Co KG – K161032), CerviFix StarLock System (Synthes USA – K994187), neon3™ (ulrich GmbH & Co KG - K150650), neon system (ulrich GmbH & Co KG - K113346)
Reference Device(s)
Not Found
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.
0
May 2, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ulrich medical USA, Inc. Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K230614
Trade/Device Name: Cortium™ Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG Dated: March 3, 2023 Received: March 6, 2023
Dear Hans 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. 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
1
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,
Colin O'neill -S
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known)
Device Name
Cortium™
Indications for Use (Describe)
Cortium is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fraumatic 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.
Cortium 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, Cortium can also be connected to Momentum via transition rods or connectors. Please refer to the Momentum Instructions for Use for a list of indications for use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ | |
|---|---|
| ☐ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for Ulrich Medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" starting from a black square. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.
| Date: | 3 March 2023 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Sponsor Contact: | Hans Stover, President & CEO |
| Proposed Trade Name: | Cortium™ |
| Common Name: | Occipital-cervical-thoracic system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3075 |
| Regulation Name: | Posterior cervical screw system |
| Product Code: | NKG |
| Device Description: | The Cortium system is a posterior occipital-cervical-thoracic (OCT) spinal |
| fixation system. The system components include longitudinal rods, screw | |
| anchors, and interconnecting devices such as anchor-to-rod and rod-to-rod | |
| connectors, rod-to-rod crosslinks and screw-to-screw crosslinks. | |
| Indications for Use: | Cortium is intended to provide immobilization and stabilization of spinal |
| segments in skeletally mature patients as an adjunct to fusion for the | |
| following acute and chronic instabilities of the craniocervical junction, 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. | |
| Cortium 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, Cortium can also be | |
| connected to Momentum via transition rods or connectors. Please refer to | |
| the Momentum Instructions for Use for a list of indications for use. | |
| Materials: | The Cortium implants are manufactured from titanium alloy (ASTM F136), |
| titanium (ASTM F67) or cobalt chrome (ASTM F1537). Instruments are | |
| predominantly manufactured from stainless steels per ASTM F899. | |
| Primary Predicate: | neon3™ (ulrich GmbH & Co KG – K161032) |
| Additional Predicates: | CerviFix StarLock System (Synthes USA – K994187), neon3™ (ulrich GmbH |
| & Co KG - K150650), neon system (ulrich GmbH & Co KG - K113346) | |
| Performance Data: | Mechanical testing of worst case Cortium constructs included ASTM F1717 static and dynamic compression bending and static torsion, F1798 tulip pull-off testing and F2706 static and dynamic compression bending and static and dynamic torsion. |
| The mechanical test results demonstrate that Cortium performance is substantially equivalent. | |
| Technological Characteristics: | Cortium possesses technological characteristics similar to one or more of the predicate devices. These include: |
| intended use (as described above) basic design (rod-based having screw anchors), material (titanium, titanium alloy, CoCr), sizes (dimensions are comparable to those offered by the predicate systems) The fundamental scientific technology of Cortium is the same as previously cleared devices. | |
| Conclusion: | Cortium possesses the same intended use and technological characteristics as the predicate devices. Therefore Cortium is substantially equivalent for its intended use. |
4