(87 days)
K12115, K132878
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests.
Yes
The device is described as a "fixation device" intended for "stabilization and fusion" in various spinal conditions, clearly indicating a direct role in treating medical conditions.
No
The M.U.S.T. Pedicle Screw System is described as a fixation device intended for stabilization and fusion of the spine, not for diagnosis.
No
The device description explicitly details various hardware components made of specific materials (Ti-6Al-4V ELI, Co-Cr-Mo) and includes mechanical performance testing, indicating it is a physical medical device system, 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 for spinal fixation and fusion. This is a therapeutic device used in vivo (within the body) during surgery.
- Device Description: The description details physical components like screws, rods, and connectors made of specific materials. These are all components of 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, 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. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/Ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Product codes
NKB, MNI, MNH, KWQ, KWP
Device Description
The M.U.S.T. Pedicle Screw System devices are fixation devices intended for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screw System includes cannulated or non-cannulated poly-axial pedicle screws (K12115, K132878), cannulated or noncannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), and cross connectors (K132878).
The new lateral connectors can be used when a certain off-set screw has to be implanted with the rod. The lateral connectors offer the same interface to the monoaxial screw (K132878). The lateral connectors are offered in three sizes (20, 40 and 60 mm sizes) to accept a 5.5mm rod and manufactured of Ti-6Al-4V ELI (ISO 5832-3, ASTM F136).
The new anodized rods and anodized enhanced rods act as a connector between the different screws to create a stable construct. The screws are used in combination with 5.5mm titanium allov rods. This allows the surqeon to choose the construct stiffness based on the indication by maintaining the screw sizes. They are offered as a 5.5mm diameter in various lengths (100, 200, 300 and 480 mm sizes) and manufactured of Ti-6AI-4V ELI (ISO 5832-3, ASTM F136).
The new rod-to-rod connectors can be used to connect two rods to increase the construct stability. The cross connectors have a medial/lateral length adjustable element in order to address different distances. Rod distances from 35mm to 98 mm can be addressed with the different connector sizes. The rod to rod connectors are manufactured of Ti-6AI-4V ELI (ISO 5832-3. ASTM F136) and the set-screws are made of Co-Cr-Mo (ISO 5832-12, ASTM F1537).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical pedicle fixation (T1-S2/ilium), anterolateral fixation (T8-L5)
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
The addition of the subject devices was evaluated by risk analysis to identify any new risks associated with the screw modification and inclusion of the rod to rod connectors, lateral connectors and anodized rods. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.
The following mechanical tests were performed or leveraged to support the substantial equivalence on the subject devices:
Rod to Rod Connectors, Lateral Connectors, Anodized Rods
-
- Static Compression Bending Strength ASTM F1717
-
- Static Torsion Strength ASTM F1717
-
- Dynamic Compression Bending Strength ASTM F1717
-
- Static Transverse Moment ASTM F1798
-
- Four-Point Dynamic Bending Strength ASTM F2193
Conclusion:
Based on the above information, the M.U.S.T. Pedicle Screw System can be considered substantially equivalent to the identified predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K121115, K141988, K141044, K132878, K041119, K984578, K983583
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
Medacta International SA % Ms. Elizabeth Wheeler Manager. Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K162061
Trade/Device Name: M.U.S.T. Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: July 26, 2016 Received: July 28, 2016
Dear Ms. Wheeler:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21CFR 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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a bold, sans-serif font. The text is black and appears to be against a white background. The name is written on a single line, with a slight shadow effect on some of the letters.
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) K162061
Device Name M.U.S.T. Pedicle Screw System
Indications for Use (Describe)
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/Ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
| 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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3
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3 510(k) Summary
- Applicant/Sponsor: 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 Bai Regulatory Affairs Manager Phone: +41 91 696 60 60 Fax: +41 91 696 60 66 Email: baj@medacta.ch
- Date Prepared: July 25, 2016 Date Revised: September 30, 2016
DEVICE INFORMATION
| Trade/Proprietary Name: | M.U.S.T. Pedicle Screw System |
|---|---|
| Common or Usual Name: | Pedicle screw spinal system |
| Classification Name: | Pedicle screw spinal system |
| Primary Product Code: | NKB |
| Secondary Product Code: | MNI, MNH, KWQ, KWP |
| Regulation Number: | 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 |
| Device Class: | III |
PREDICATE DEVICE INFORMATION
Primary Predicate: M.U.S.T. Pedicle Screw System, K121115, Medacta International SA
Additional Predicates M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Extension, K141044, Medacta International SA M.U.S.T. Extension, K132878, Medacta International SA Expendium Spine System, K041119, DePuy Spine, Inc.
4
Synergy D2 Spinal Implants, K984578, Interpore Cross International MOSS Miami Spinal System, K983583, DePuy Inc.
DEVICE DESCRIPTION
The M.U.S.T. Pedicle Screw System devices are fixation devices intended for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screw System includes cannulated or non-cannulated poly-axial pedicle screws (K12115, K132878), cannulated or noncannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), and cross connectors (K132878).
The new lateral connectors can be used when a certain off-set screw has to be implanted with the rod. The lateral connectors offer the same interface to the monoaxial screw (K132878). The lateral connectors are offered in three sizes (20, 40 and 60 mm sizes) to accept a 5.5mm rod and manufactured of Ti-6Al-4V ELI (ISO 5832-3, ASTM F136).
The new anodized rods and anodized enhanced rods act as a connector between the different screws to create a stable construct. The screws are used in combination with 5.5mm titanium allov rods. This allows the surqeon to choose the construct stiffness based on the indication by maintaining the screw sizes. They are offered as a 5.5mm diameter in various lengths (100, 200, 300 and 480 mm sizes) and manufactured of Ti-6AI-4V ELI (ISO 5832-3, ASTM F136).
The new rod-to-rod connectors can be used to connect two rods to increase the construct stability. The cross connectors have a medial/lateral length adjustable element in order to address different distances. Rod distances from 35mm to 98 mm can be addressed with the different connector sizes. The rod to rod connectors are manufactured of Ti-6AI-4V ELI (ISO 5832-3. ASTM F136) and the set-screws are made of Co-Cr-Mo (ISO 5832-12, ASTM F1537).
INDICATIONS FOR USE
The M.U.S.T. Pedicle screws system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Discussion:
The Indications for Use Statement is identical to the predicate device.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The indications for use, design features, and materials of the subject devices are substantially equivalent to those of the predicate devices.
5
| Feature | Lateral Connectors | M.U.S.T. Pedicle Screw
System
K121115, K132878 | DePuy Expedium
K041119 |
|-----------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------|
| Material of
Construction | Connector: Ti-6Al-4V ELI
(ISO 5832-3, ASTM F136)
Set Screw: Co-Cr-Mo (ISO
5832-12, ASTM F1537) | SAME | SAME |
| Sterilization
Method | Sterile: Gamma
Non-sterile | SAME | SAME |
| Device Usage | Single Use | SAME | SAME |
| Sizes | 3 Sizes (20mm, 40mm,
60mm) | 40mm | 3 sizes (20mm, 50mm,
150mm |
| Rod Compatibility | 5.5mm | SAME | SAME |
| Shelf Life | 5 years | 5 years | SAME |
| Features | Anodized Rods and Anodized Enhanced
Rods | M.U.S.T. Pedicle Screw System
K121115, K132878, K141044, K141988 |
|-----------------------------|---------------------------------------------|---------------------------------------------------------------------|
| Material of
Construction | Ti-6Al-4V ELI (ISO 5832-3, ASTM F136) | SAME |
| Adonization | Gold | SAME (Screws, Hooks, Cross Connectors) |
| Sterilization
Method | Sterile: Gamma
Non-sterile | SAME |
| Device
Usage | Single Use | SAME |
| Diameter | 5.5mm | SAME |
| Lengths | 4 sizes (100mm, 200mm, 300mm, 480mm) | SAME |
| Shelf Life | 5 years | SAME |
6
| Features | Rod to Rod
Connectors | M.U.S.T.
Pedicle Screw
System
K121115 | Synergy Spinal
System
K984578 | DePuy Moss
Miami
K983583 | DePuy
Expedium
K041119 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------|
| Material of
Construction | Connector: Ti-6Al-4V ELI (ISO 5832-3, ASTM F136)
Set Screw: Co-Cr-Mo (ISO 5832-12, ASTM F1537) | SAME | Titanium and
Stainless Steel | Connector: Ti-6Al-4V ELI (ISO 5832-3, ASTM F136)
Stainless Steel
(ASTM F138) | Connector: Ti-6Al-4V ELI (ISO 5832-3, ASTM F136) |
| Sterilization
Method | Sterile: Gamma
Non-sterile | SAME | UNKNOWN | SAME | SAME |
| Device
Usage | Single Use | SAME | SAME | SAME | SAME |
| Lengths | 4 sizes
(10.5mm,
16mm, 29mm,
31mm) | N/A | UNKNOWN | UNKNOWN | 4 Sizes (5mm,
10mm, 15mm,
20mm) |
| Rod
Diameter | 5.5mm up to
6.35mm | 5.5mm | 4.75mm,
6.35mm | 5.0mm, 6.35mm | 5.5mm |
| Shelf Life | 5 years | SAME | UNKNOWN | SAME | SAME |
| Additional
Features | In Line, In Line
Open, Domino
Narrow, Domino
Wide, Domino
Open, Tulip
Based Narrow,
Tulip Base Wide | NA | UNKNOWN | UNKNOWN | In Line, Domino |
The fundamental scientific technology of the devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
7
PERFORMANCE TESTING
The addition of the subject devices was evaluated by risk analysis to identify any new risks associated with the screw modification and inclusion of the rod to rod connectors, lateral connectors and anodized rods. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.
The following mechanical tests were performed or leveraged to support the substantial equivalence on the subject devices:
Rod to Rod Connectors, Lateral Connectors, Anodized Rods
-
- Static Compression Bending Strength ASTM F1717
-
- Static Torsion Strength ASTM F1717
-
- Dynamic Compression Bending Strength ASTM F1717
-
- Static Transverse Moment ASTM F1798
-
- Four-Point Dynamic Bending Strength ASTM F2193
Conclusion:
Based on the above information, the M.U.S.T. Pedicle Screw System can be considered substantially equivalent to the identified predicate devices.