(20 days)
Not Found
No
The device description focuses on physical components (screws, connectors) and material properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are non-clinical mechanical tests.
Yes
The device is described as a 'posterior cervical screw system' intended to provide 'immobilization of spinal segments as an adjunct to fusion' for various conditions like 'traumatic spinal fractures', 'instability or deformity', 'tumors', and 'degenerative disease'. These uses directly treat or alleviate a disease or injury, which aligns with the definition of a therapeutic device.
No
This device is a surgical implant (posterior cervical screw system) intended to provide immobilization and stabilization, not to diagnose a condition.
No
The device description clearly states it is a "posterior cervical screw system" and describes physical components like screws and connectors made of Ti-6Al-4V ELI. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide immobilization and stabilization of spinal segments. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details the physical components of the system (screws, connectors, rods) and their material, all of which are consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instability or deformity; failed previous (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The M.U.S.T. Mini posterior cervical screw 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 M.U.S.T. Mini posterior cervical screw system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screw system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.
When used with the Occipital Plate the M.U.S.T Mini posterior cervical screw system is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - 73) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The M.U.S.T. MINI poly-axial screws and lateral connectors are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369).
The poly-axial screws included in the line-extension are equivalent to the ones legally marketed, with the exception of individual length. For the Ø4.5mm poly screws, the length is extended from "26 to 50mm" to "14 to 50mm" (adding the 14 to 24 mm sizes).
The range of Ø4mm and Ø4.5mm partial thread screws design is extended from "26 to 42mm" to "26 to 50mm" (adding the 44 to 50mm sizes) with 2 mm of increments. For the Ø3.5mm partial thread screws, the lengths of 26 to 40mm are added, 2 mm increments.
The range of full thread screw design Ø4.5mm is extended from 26-50mm to 14-50mm with 2 mm increments.
All the poly-axial screws features are the same: intended use, diameters, pitch, threading pitch, length increment, range of motion, driving interface, material, surface finishing, manufacturing process, washing, packaging and final storing condition.
The lateral connectors introduced as line-extension are equivalent to the ones legally marketed, with the exception of the length: same intended use, diameter of the shaft, fixing interfaces, material, surface finishing, machining, washing, packaging and final storing condition.
The Lateral connector included in this line extension are aimed the product range from 10-15mm to 10-30mm, in steps of 5mm.
The M.U.S.T. MINI poly-axial screws and lateral connectors are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)), the same material of the previous cleared M.U.S.T. MINI M.U.S.T. MINI Posterior Cervical Screws System (K171369).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C1 to C7), thoracic spine from T1-T3, occipito-cervico-thoracic junction (occiput - 73)
Indicated Patient Age Range
skeletally mature patient
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)
- Engineering Rationale: A comparative analysis of the subject devices to the identified predicate and reference devices was performed to determine if the line-extension created a new worst-case product size. It was determined that the subject poly-axial screws and lateral connectors are substantially equivalent to the previously cleared predicate device and that the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial MUST MINI implants product range.
- Non-Clinical Studies:
- Performance Tests: Static and Fatigue Testing: ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model; Static and Fatigue Testing: ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Cadaver Testing
- Design Comparisons
- Bacterial Endotoxin Testing (LAL Method)
- Clinical Studies: No clinical studies were conducted.
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.
K171369, K142838, K070573, K023675, K991089, K042508
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.
0
Image /page/0/Picture/0 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
February 10, 2020
Medacta International SA % Mr. Chris Lussier Senior Director of Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K200130
Trade/Device Name: M.U.S.T. MINI Posterior Cervical Screws System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG, KWP Dated: January 17, 2020 Received: January 21, 2020
Dear Mr. Lussier:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 (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 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.
Ronald P. Jean, Ph.D. Director (Acting) 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
M.U.S.T. MINI Posterior Cervical Screws System
Indications for Use (Describe)
The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instability or deformity; failed previous (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The M.U.S.T. Mini posterior cervical screw 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 M.U.S.T. Mini posterior cervical screw system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screw system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.
When used with the Occipital Plate the M.U.S.T Mini posterior cervical screw system is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - 73) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
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
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director of Quality and Regulatory, Medacta USA Date Prepared: January 17, 2019 Date Revised: February 10, 2020
II. Device
| Device Proprietary Name: | M.U.S.T. MINI Posterior Cervical Screws System |
|---|---|
| Common or Usual Name: | Spinal Interlaminal Fixation Orthosis |
| Classification Name: | Appliance, Fixation, Spinal Interlaminal |
| Primary Product Code: | NKG, KWP |
| Regulation Number: | 21 CFR, 888.3075, 21 CFR 888.3050 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device:
-
M.U.S.T. MINI Posterior Cervical Screws System, K171369, Medacta International SA ●
Additional predicate devices: -
Synapse Occipital-Cervical-Thoracic (OCT) System, K142838, Synthes USA Products, . LLC (also referred to as Synthes' Synapse System)
-
Synapse System, K070573, Synthes Spine Co. LP, (also referred to as Synthes' ● Synapse System)
-
Synthes Cervifix/Axon, K023675, Synthes (USA), (also referred to as Synthes ) Axon ● System)
-
Synthes Cervifix System, K991089, Synthes Spine, (also referred to as Synthes Axon System)
-
Depuy Mountaneer OCT spinal system, K042508, DEPUY SPINE (USA), INC. ●
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IV. Device Description
The M.U.S.T. MINI poly-axial screws and lateral connectors are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369).
The poly-axial screws included in the line-extension are equivalent to the ones legally marketed, with the exception of individual length. For the Ø4.5mm poly screws, the length is extended from "26 to 50mm" to "14 to 50mm" (adding the 14 to 24 mm sizes).
The range of Ø4mm and Ø4.5mm partial thread screws design is extended from "26 to 42mm" to "26 to 50mm" (adding the 44 to 50mm sizes) with 2 mm of increments. For the Ø3.5mm partial thread screws, the lengths of 26 to 40mm are added, 2 mm increments.
The range of full thread screw design Ø4.5mm is extended from 26-50mm to 14-50mm with 2 mm increments.
All the poly-axial screws features are the same: intended use, diameters, pitch, threading pitch, length increment, range of motion, driving interface, material, surface finishing, manufacturing process, washing, packaging and final storing condition.
The lateral connectors introduced as line-extension are equivalent to the ones legally marketed, with the exception of the length: same intended use, diameter of the shaft, fixing interfaces, material, surface finishing, machining, washing, packaging and final storing condition.
The Lateral connector included in this line extension are aimed the product range from 10-15mm to 10-30mm, in steps of 5mm.
The M.U.S.T. MINI poly-axial screws and lateral connectors are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)), the same material of the previous cleared M.U.S.T. MINI M.U.S.T. MINI Posterior Cervical Screws System (K171369).
V. Indications for Use
The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures, and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; 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 M.U.S.T. Mini posterior cervical screw 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.
5
In order to achieve additional levels of fixation, the M.U.S.T. Mini posterior cervical screw system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screw system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.
When used with the Occipital Plate the M.U.S.T Mini posterior cervical screw system is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - T3) in treatment of the instabilities mentioned above. including occipitocervical dislocation.
VI. Comparison of Technological Characteristics
The M.U.S.T. MINI Posterior Cervical Screws System poly-axials screws and the predicate devices share the following characteristics:
- diameter and length;
- materials of construction; ●
- biocompatibility; ●
- device usage;
- sterility;
- shelf life; and ●
- packaging.
- lengths
The poly-axials screws are substantially equivalent to the primary predicate device M.U.S.T. MINI Posterior Cervical Screws System (K171369).
The M.U.S.T. MINI Posterior Cervical Screws System lateral connectors and the predicate devices share the following characteristics:
- diameter
- materials of construction; ●
- biocompatibility;
- device usage; ●
- sterility;
- shelf life: and o
- packaging. ●
The Extension M.U.S.T. MINI Posterior Cervical Screws System lateral connectors are technologically different from the predicate devices as follows:
- · lengths
As seen above, the M.U.S.T. MINI Posterior Cervical Screws System lateral connectors are substantially equivalent to the predicate devices in terms of diameter; materials, biocompatibility, device usage, sterility, shelf life and packaging.
Regarding the M.U.S.T. MINI Posterior lateral connectors, the only difference between the subject and predicate devices is the lengths: extended from "10m and 15mm" to 10mm, 15mm, 20mm, 25mm, and 30mm (an addition of the 20m, 25mm, and 30mm lengths). This addition of connector
6
lengths does not introduce any new worst case as compared to the shorter lengths and thus there is no impact on safety and performance of the overall construct.
The new feature has been designed in order to increase the product range. This technological difference does not raise new questions of safety or effectiveness and a comparison evaluation shows there are no new risks associated with the subject device design.
VII. Performance Data
- Engineering Rationale
A comparative analysis of the subject devices to the identified predicate and reference devices was performed to determine if the line-extension created a new worst-case product size. It was determined that the subject poly-axial screws and lateral connectors are substantially equivalent to the previously cleared predicate device and that the lineextension can be considered within the scope of the design verification and validation testing previously completed for the initial MUST MINI implants product range.
The predicate M.U.S.T. MINI Posterior Cervical Screws System (cleared under K171369) was tested using the worst-case device for each of the following tests:
Non-Clinical Studies
- Performance Tests ●
- o Static and Fatigue Testing: ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- o Static and Fatigue Testing: ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- o Static and Fatigue Testing: ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Cadaver Testing
- Design Comparisons ●
- Bacterial Endotoxin Testing (LAL Method) ●
Clinical Studies
- o No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the M.U.S.T. MINI Posterior Cervical Screws System poly-axial screws and lateral connectors are as safe and effective as the predicate devices.
Although minor differences in length exist between the subject and primary predicate device, testing supports that these differences do not raise any new questions of safety or effectiveness. Therefore, it is concluded that the M.U.S.T. MINI Posterior Cervical Screws System poly-axial screws and lateral connectors are substantially equivalent to the identified predicate devices.