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.

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.

AI/ML Overview

The provided text describes the submission for a medical device called the "M.U.S.T. MINI Posterior Cervical Screws System" to the FDA for 510(k) clearance. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical studies for new uses.

Therefore, the document does not contain information about:

Acceptance criteria for an AI/algorithm-based device and reported device performance. The device is a physical surgical implant, not an AI or algorithm.
Sample size used for a test set or data provenance for an AI/algorithm.
Number of experts or their qualifications for establishing ground truth for an AI/algorithm test set.
Adjudication method for an AI/algorithm test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data) for an AI/algorithm.
Sample size for a training set (AI/algorithm).
How ground truth for a training set was established (AI/algorithm).

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal screws system) through:

Comparison of Technological Characteristics: Detailed tables comparing the subject device's materials, dimensions (screw diameter, length, rod diameter, length), device usage, biocompatibility, and sterilization status to several predicate devices (e.g., Synthes Synapse Systems, Synthes Cervifix/Axon Systems, Medtronic Vertex Reconstruction System).
Performance Data (Non-Clinical Studies): The document lists various mechanical tests conducted to support substantial equivalence. These tests include:
- Static and dynamic compression (Per ASTM F1717-15)
- Static and dynamic torsion (Per ASTM F1717-15)
- Static axial and torsional grip (Per ASTM F1798-13)
- A-P screw pull out (Per ASTM F1798-13)
- Flexion-extension (Per ASTM F1798-13)
- Torque to failure
- Cadaver Testing (listed but no details provided)
- Design Comparisons
- Pyrogenicity (Bacterial Endotoxin Test and Pyrogen Test per European Pharmacopoeia and USP)
Acceptance Criteria for the Mechanical Tests: The text states that "acceptance criteria that were based on standards and FDA guidance document 'FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s'". However, the specific quantitative acceptance criteria values (e.g., minimum load to failure, maximum displacement) and the exact reported performance results of the subject device against these criteria are not explicitly provided in the excerpt. The document states that these tests "support a substantial equivalence determination," implying the device met these criteria.

In summary, the provided document is a 510(k) summary for a physical medical device and does not contain the information requested regarding acceptance criteria and studies for an AI/algorithm-based device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K171369

Device Name

M.U.S.T. MINI Posterior Cervical Screws System

Indications for Use (Describe)

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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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. .

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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 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

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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

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[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. MINIPosterior CervicalScrews System:Polyaxial Screws(Subject Device)	Synthes SynapseSystemsK070573 andK142838(Predicate Device)	SynthesCervifix/AxonSystemsK991089 andK023675(Predicate Device)	Medtronic VertexReconstructionSystemK123906(Predicate Device)
Material	Titanium Alloy(ELI)	TitaniumAluminumNiobium	TitaniumAluminumNiobium	TitaniumAluminumNiobium, 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 Ø4.0 mm: 10 to 40mm(Full Thread)Ø 4.0 mm and Ø4.5 mm:26 to 42 mm(Partial Thread)Ø 4.5 mm: 26 to 50mm(Full Thread)	Cancellous: 8-50mmSmooth shaft (10mm w/o thread):18-50 mm	Cancellous: 8-26mmCortex: 28-50 mm	Ø 3.5 mm: 10-40mm (Full Thread)Ø 4.0 mm and Ø4.5 mm: 10-52 mm(Full Thread)Ø 3.5 mm and Ø4.0 mm: 18-40 mm(Partial Thread)
Device Usage	Single Use	Single Use	Single Use	Single Use
Biocompatibility	Implant withpermanent >30 day	Implant withpermanent >30 day	Implant withpermanent >30 day	Implant withpermanent >30 day
Sterilization	Yes	Yes	Yes	Sterile/Non-Sterile

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Parameters	M.U.S.T. MINIPosterior CervicalScrews System: Rods(Subject Device)	Synthes SynapseSystemsK070573 and K142838(Predicate Device)	Synthes Cervifix/AxonSystemsK991089 and K023675(Predicate Device)
Material	Titanium Alloy (ELI)and CoCrMo	Titanium AluminumNiobium	Titanium Alloy (TAN)and Commercial PureTitanium
Diameter	Straight: Ø 3.5 mmTapered: Ø 3.5/5.5 mm	Straight: Ø 3.5 mmTapered: Ø 3.5/5.0 mm,Ø 3.5/6.0 mm, Ø 4.0/5.0mm and Ø 4.0/6.0 mm	Straight: Ø 3.5 mmTapered: Ø 3.5/5.0 mmand Ø 3.5/6.0 mm
Length	Straight: 80 mm, 120mm, 240 mm, 350 mmTapered: 180 mm,360 mm, 420 mm,600 mm	Straight: 80 mm,120 mm, 240 mm,350 mmTapered: 40 mm,80 mm	Straight: 80 mm,120 mm, 240 mmTapered: 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. MINIPosterior CervicalScrews System:Connectors(Subject Device)	Synthes SynapseSystemsK070573 and K142838(Predicate Device)	Synthes Cervifix/AxonSystemsK991089 and K023675(Predicate Device)
Material	Titanium Alloy (ELI)	Titanium Alloy (ELI)	Titanium Alloy (ELI)
Lateral Connector	Diameter: Ø 3.5 mmLength: 10 mm and 15 mm	Diameter: Ø 3.5 mmand Ø 4.0 mmLength: Unknown	Diameter: Ø 3.5 mmLength: Unknown
Rod to Rod Connector	Diameter: Ø 3.5 to Ø 5.5 mm	Diameter: Ø 3.5 to Ø 3.5 mmØ 3.5 to Ø 4.0 mmØ 3.5 to Ø 5.0 mmØ 3.5 to Ø 6.0 mm	Diameter: Ø 3.5 to Ø 3.5 mmØ 3.5 to Ø 5.0 mmØ 3.5 to Ø 6.0 mm
Standard CrossConnector	Adjustable Length: 15 to 70 mm	Adjustable Length: 60 to 75 mm	Length: 60 mm and 75 mm
Screw to Screw CrossConnector	Distance: 22-30 mm,29-37 mm, 36-44 mm,43-51 mm, 50-58 mm	Distance: 4 adjustablesizes (specific distanceunknown)	N/A
Device Usage	Single Use	Single Use	Single Use

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Parameters	M.U.S.T. MINIPosterior CervicalScrews System:Connectors(Subject Device)	Synthes SynapseSystemsK070573 and K142838(Predicate Device)	Synthes Cervifix/AxonSystemsK991089 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 CervicalScrews System(Subject Device)	Synthes Synapse SystemsK070573 and K142838(Predicate Device)
Material	Titanium Alloy (ELI)	Titanium Alloy (ELI)
Types	Straight, Angled (right/left), andOffset (right/left)	Straight, Angled (right/left), andOffset (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.

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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
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 <85>) and the Pyrogen Test according to USP chapter <151> for pyrogenicity determination.
- The subject devices are not labeled as non-pyrogenic or pyrogen free. о

Clinical Studies

No clinical studies were conducted. .

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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.

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Regulation Number and Section

§ 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.