(83 days)
Not Found
No
The device description and intended use focus on the mechanical components and surgical application of a spinal screw system, with no mention of AI or ML capabilities.
Yes
The device is described as an implantable system intended for "immobilization of spinal segments" and to "stabilize and fuse the spine" for various conditions, directly treating physical ailments.
No
This device is a surgical implant (posterior cervical screws system) intended for immobilization and stabilization of spinal segments, not for diagnosis.
No
The device description explicitly states it is a multi-component system constructed from titanium and CoCrMo materials, consisting of rods, screws, hooks, and connectors. This indicates it is a hardware-based medical device, not software-only.
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 surgical implant system designed to provide mechanical support and stabilization to the spine. It is used in vivo (within the body) during surgical procedures.
- Device Description: The description details a multi-component system made of titanium and CoCrMo materials, consisting of rods, screws, hooks, and connectors. These are physical components implanted into the body.
- 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, etc.) 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 screws system 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 from T1 to 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 Screws System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited 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 Screws 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 Screws 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.
Product codes
NKG, KWP
Device Description
The M.U.S.T. MINI Posterior Cervical Screws System is a multi-component system constructed from titanium and CoCrMo materials, consisting of rods that are longitudinally interconnected and anchored to adjacent vertebrae using screws. Stability enhancement is possible by means of interconnection mechanisms and transverse connectors used as cross connectors.
The M.U.S.T. MINI Posterior Cervical Screws System is intended to stabilize and fuse the spine in degenerative disc disease, spinal fusion, cervical fractures, and in surgically repaired spinal pseudo-arthrosis. In addition, the M.U.S.T. MINI Posterior Cervical Screws System is used in deformity correction e.g. scoliosis to correct and stabilize the spine.
The M.U.S.T. MINI Posterior Cervical Screws System consists of polyaxial screws (full and partially threaded), cannulated polyaxial screws (full and partially threaded), hooks, cross connectors, connectors and rods (straight and transition) are manufactured of Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6Al-4V ELI). The M.U.S.T. MINI Posterior Cervical Screws System rods (straight and transition) are manufactured of Cobalt-Chromium-Molybdenum Alloy.
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 from T1 to T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Mechanical Tests:
- Static and dynamic compression per ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
- Static and dynamic torsion per ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
- Static axial and torsional grip per ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.
- A-P screw pull out per ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.
- Flexion-extension per ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.
- Torque to failure.
Cadaver Testing.
Design Comparisons.
Pyrogenicity:
- The Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
K142838, K070573, K023675, K991089, K123906, K110197, K030197, K121725, K132878, K141988, K153664, K162061, K171170
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Elizabeth Rose, MST, RAC Regulatory Affairs Manager Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
August 1, 2017
Re: K171369
Trade/Device Name: M.U.S.T. MINI Posterior Cervical Screws System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 10, 2017 Received: May 10, 2017
Dear Ms. Rose:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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 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
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 screws system is intended to provide immobilization of spinal segments as an adjunct to 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 screws 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 screws 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 screws 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
3.0 510(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 Manager Consultant: Elizabeth Rose, Regulatory Affairs Manager, Mapi USA, Inc. Date Prepared: May 10, 2017 Date Revised: July 25, 2017
II. Device
| Device Proprietary Name: | M.U.S.T. MINI Posterior Cervical Screws System |
|---|---|
| Common or Usual Name: | Posterior Cervical System |
| Classification Name: | Orthosis Cervical Pedicle Screw Spinal Fixation |
| Primary Product Code: | NKG |
| Secondary Product Code: | KWP |
| Device Classification | Unclassified |
Predicate Device III.
Substantial equivalence is claimed to the following devices: Primary Predicate:
-
Synapse Occipital-Cervical-Thoracic (OCT) System, K142838, Synthes USA Products, ● LLC (also referred to as Synthes' Synapse System)
Additional Predicates -
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)
-
. Vertex Reconstruction System, Vertex Select Reconstruction System, K123906, Medtronic Sofamor Danek USA, Inc. (also referred to as Medtronic's Vertex)
-
Exactech Gibralt Spinal System, K110197, Exactech, Inc. ●
-
Blackstone Posterior Cervical System, K030197, Blackstone Medical, Inc. .
4
- Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System, K121725, Pioneer Surgical ● Technology
- M.U.S.T. Extension, K132878, Medacta International SA (also known as M.U.S.T. Pedicle ● Screws System)
- M.U.S.T. Pedicle Screws System, K141988, Medacta International SA ●
- M.U.S.T. Pedicle Screws System, K153664, Medacta International SA .
- . M.U.S.T. Pedicle Screws System, K162061, Medacta International SA
- M.U.S.T. Pedicle Screw System Extension Straight Connectors and Additional Screws. ● K171170, Medacta International SA
IV. Device Description
The purpose of this submission is to gain clearance for the M.U.S.T. MINI Posterior Cervical Screws System. The M.U.S.T. MINI Posterior Cervical Screws System is a multi-component system constructed from titanium and CoCrMo materials, consisting of rods that are longitudinally interconnected and anchored to adjacent vertebrae using screws. Stability enhancement is possible by means of interconnection mechanisms and transverse connectors used as cross connectors.
The M.U.S.T. MINI Posterior Cervical Screws System is intended to stabilize and fuse the spine in degenerative disc disease, spinal fusion, cervical fractures, and in surgically repaired spinal pseudo-arthrosis. In addition, the M.U.S.T. MINI Posterior Cervical Screws System is used in deformity correction e.g. scoliosis to correct and stabilize the spine.
The M.U.S.T. MINI Posterior Cervical Screws System consists of polyaxial screws (full and partially threaded), cannulated polyaxial screws (full and partially threaded), hooks, cross connectors, connectors and rods (straight and transition) are manufactured of Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6Al-4V ELI). The M.U.S.T. MINI Posterior Cervical Screws System rods (straight and transition) are manufactured of Cobalt-Chromium-Molybdenum Alloy.
The M.U.S.T. MINI Posterior Cervical Screws System is similar to competitor predicate devices Synthes' Axon System (K991089 and K023675). Synthes' Synapse System (K070573 and K142838) and Medtronic's Vertex System (K123906).
V. Indications for Use
The M.U.S.T. MINI Posterior Cervical Screws System 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 from T1 to 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
5
M.U.S.T. MINI Posterior Cervical Screws System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited 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 Screws 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 Screws 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.
VI. Comparison of Technological Characteristics
The M.U.S.T. MINI Posterior Cervical Screws System and the predicate devices share the following characteristics:
- indications for use;
- . material:
- o The materials for the Rods, Connectors, and Hooks are made of the similar materials of titanium alloy and CoCrMo. The Polyaxial Screws are made of titanium alloy Eli versus the predicate which are made of titanium aluminum niobium.
- screw diameters: ●
- screw driving interface:
- rod diameters:
- rod straight lengths:
- connector designs;
- hook designs:
- hook sizes:
- sterile:
- device usage.
The M.U.S.T. MINI Posterior Cervical Screws System is technologically different from the predicate devices as follows:
- polyaxial screw lengths:
- polyaxial angulation:
- rod tapered lengths.
The M.U.S.T. MINI Posterior Cervical Screws System components are manufactured from Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy (ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium-6Aluminum-4Vanadium Alloy and ASTM F136-13 Standard Specification For Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy For Surgical Implant Applications) and/or Cobalt-Chromium-Molybdenum Alloy (Co-Cr-Mo) (ISO 5832-12 Second Edition 2007-05-01: Implants For Surgery-- Metallic Materials -- Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
6
[Including: Technical Corrigendum 1 (2008)] and ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538 and UNS R31539)).
The polyaxial screws, hooks, lateral connector, rod to rod connector, cross connector clamp and spinous reconstruction cross connectors are Type III color anodized.
These materials have a long history of use in implantable orthopedic devices and material information has been provided in the listed predicate devices' 510(k) submissions; Synthes' Axon System (K991089 and K023675), Synthes' Synapse System (K070573 and K142838) and Medtronic's Vertex System (K123906).
A comparison of the subject and predicate devices are provided in the tables below.
Technological comparison
| Parameters | M.U.S.T. MINI
Posterior Cervical
Screws System:
Polyaxial Screws
(Subject Device) | Synthes Synapse
Systems
K070573 and
K142838
(Predicate Device) | Synthes
Cervifix/Axon
Systems
K991089 and
K023675
(Predicate Device) | Medtronic Vertex
Reconstruction
System
K123906
(Predicate Device) |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium Alloy
(ELI) | Titanium
Aluminum
Niobium | Titanium
Aluminum
Niobium | Titanium
Aluminum
Niobium, Nitinol |
| Screw Diameter | 3.5 mm, 4.0 mm,
4.5 mm | 3.5 mm, 4.0 mm,
4.5 mm | 3.5 mm, 4.0 mm | 3.5 mm, 4.0 mm,
4.5 mm |
| Length | Ø 3.5 mm and Ø
4.0 mm: 10 to 40
mm
(Full Thread)
Ø 4.0 mm and Ø
4.5 mm:
26 to 42 mm
(Partial Thread)
Ø 4.5 mm: 26 to 50
mm
(Full Thread) | Cancellous: 8-50
mm
Smooth shaft (10
mm w/o thread):
18-50 mm | Cancellous: 8-26
mm
Cortex: 28-50 mm | Ø 3.5 mm: 10-40
mm (Full Thread)
Ø 4.0 mm and Ø
4.5 mm: 10-52 mm
(Full Thread)
Ø 3.5 mm and Ø
4.0 mm: 18-40 mm
(Partial Thread) |
| Device Usage | Single Use | Single Use | Single Use | Single Use |
| Biocompatibility | Implant with
permanent >30 day | Implant with
permanent >30 day | Implant with
permanent >30 day | Implant with
permanent >30 day |
| Sterilization | Yes | Yes | Yes | Sterile/Non-Sterile |
7
| Parameters | M.U.S.T. MINI
Posterior Cervical
Screws System: Rods
(Subject Device) | Synthes Synapse
Systems
K070573 and K142838
(Predicate Device) | Synthes Cervifix/Axon
Systems
K991089 and K023675
(Predicate Device) |
|------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Material | Titanium Alloy (ELI)
and CoCrMo | Titanium Aluminum
Niobium | Titanium Alloy (TAN)
and Commercial Pure
Titanium |
| Diameter | Straight: Ø 3.5 mm
Tapered: Ø 3.5/5.5 mm | Straight: Ø 3.5 mm
Tapered: Ø 3.5/5.0 mm,
Ø 3.5/6.0 mm, Ø 4.0/5.0
mm and Ø 4.0/6.0 mm | Straight: Ø 3.5 mm
Tapered: Ø 3.5/5.0 mm
and Ø 3.5/6.0 mm |
| Length | Straight: 80 mm, 120
mm, 240 mm, 350 mm
Tapered: 180 mm,
360 mm, 420 mm,
600 mm | Straight: 80 mm,
120 mm, 240 mm,
350 mm
Tapered: 40 mm,
80 mm | Straight: 80 mm,
120 mm, 240 mm
Tapered: 120/170 mm,
240/250 mm,
190/500 mm |
| Device Usage | Single Use | Single Use | Single Use |
| Biocompatibility | Implant with permanent
30 day | Implant with permanent
30 day | Implant with permanent
30 day |
| Sterilization | Sterile | Sterile | Sterile |
| Parameters | M.U.S.T. MINI
Posterior Cervical
Screws System:
Connectors
(Subject Device) | Synthes Synapse
Systems
K070573 and K142838
(Predicate Device) | Synthes Cervifix/Axon
Systems
K991089 and K023675
(Predicate Device) |
|-----------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Material | Titanium Alloy (ELI) | Titanium Alloy (ELI) | Titanium Alloy (ELI) |
| Lateral Connector | Diameter: Ø 3.5 mm
Length: 10 mm and 15 mm | Diameter: Ø 3.5 mm
and Ø 4.0 mm
Length: Unknown | Diameter: Ø 3.5 mm
Length: Unknown |
| Rod to Rod Connector | Diameter: Ø 3.5 to Ø 5.5 mm | Diameter: Ø 3.5 to Ø 3.5 mm
Ø 3.5 to Ø 4.0 mm
Ø 3.5 to Ø 5.0 mm
Ø 3.5 to Ø 6.0 mm | Diameter: Ø 3.5 to Ø 3.5 mm
Ø 3.5 to Ø 5.0 mm
Ø 3.5 to Ø 6.0 mm |
| Standard Cross
Connector | Adjustable Length: 15 to 70 mm | Adjustable Length: 60 to 75 mm | Length: 60 mm and 75 mm |
| Screw to Screw Cross
Connector | Distance: 22-30 mm,
29-37 mm, 36-44 mm,
43-51 mm, 50-58 mm | Distance: 4 adjustable
sizes (specific distance
unknown) | N/A |
| Device Usage | Single Use | Single Use | Single Use |
8
| Parameters | M.U.S.T. MINI
Posterior Cervical
Screws System:
Connectors
(Subject Device) | Synthes Synapse
Systems
K070573 and K142838
(Predicate Device) | Synthes Cervifix/Axon
Systems
K991089 and K023675
(Predicate Device) |
|------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Biocompatibility | Implant with permanent
30 day | Implant with permanent
30 day | Implant with permanent
30 day |
| Sterilization | Sterile | Sterile | Sterile |
| Parameters | M.U.S.T. MINI Posterior Cervical
Screws System
(Subject Device) | Synthes Synapse Systems
K070573 and K142838
(Predicate Device) |
|------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------|
| Material | Titanium Alloy (ELI) | Titanium Alloy (ELI) |
| Types | Straight, Angled (right/left), and
Offset (right/left) | Straight, Angled (right/left), and
Offset (right/left) |
| Size | Small (4.5 mm) and Large (6.0 mm) | Small (4.5 mm) and Large (6.0 mm) |
| Device Usage | Single Use | Single Use |
| Biocompatibility | Implant with permanent >30 day | Implant with permanent >30 day |
| Sterilization | Sterile | Sterile |
Discussion
As seen above, the technological differences between the subject and predicate devices do not raise new questions of safety and/or effectiveness. The M.U.S.T. MINI Posterior Cervical Screws System is the same or similar to the predicate devices in terms of intended use, materials of construction, design, size, diameter, device usage, and sterility. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the M.U.S.T. MINI Posterior Cervical Screws System to the identified predicate devices.
9
Performance Data VII.
The following mechanical tests are being provided in support of a substantial equivalence determination. Based on the risk analysis, testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance document "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s".
Non-Clinical Studies
- . Mechanical Tests
- o Static and dynamic compression
- Per ASTM F1717-15 Standard Test Methods for Spinal Implant I Constructs in a Vertebrectomy Model
- Static and dynamic torsion O
- Per ASTM F1717-15 Standard Test Methods for Spinal Implant . Constructs in a Vertebrectomy Model
- o Static axial and torsional grip
- Per ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue . Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- 0 A-P screw pull out
- . Per ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- o Flexion-extension
- . Per ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- 0 Torque to failure
- o Static and dynamic compression
- Cadaver Testing ●
- Design Comparisons
- Pyrogenicity ●
- o The Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
- The subject devices are not labeled as non-pyrogenic or pyrogen free. о
Clinical Studies
- No clinical studies were conducted. .
10
VIII. Conclusion
The information provided above supports that the M.U.S.T. MINI Posterior Cervical Screws System is as safe and effective as the predicate devices. Therefore, it is concluded that the M.U.S.T. MINI Posterior Cervical Screws System is substantially equivalent to the predicate devices.
-------------------------------------This space intentionally left blank------------------------------------------------------------------------------------------------------