(68 days)
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device, the M.U.S.T. Pedicle Screws System, is intended for posterior non-cervical pedicle fixation and non-pedicle fixation or anterolateral fixation. It is indicated as an adjunct to fusion for various medical conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. These uses directly involve treating or mitigating diseases and conditions, which aligns with the definition of a therapeutic device.
No
The M.U.S.T. Pedicle screws system is an implant intended for spinal stabilization and fusion, not for diagnosing conditions.
No
The device description clearly states that the device is a system of pedicle screws, rods, and connectors, which are physical implants made of metallic materials. This is a hardware medical device, not software.
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 device for surgical implantation to stabilize the spine. This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details physical components like screws, rods, and connectors made of specific materials. These are all elements of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis or monitoring of a disease state through in vitro testing.
The device is a surgical implant system used to treat spinal conditions, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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 (78-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, KWQ, KWP
Device Description
The M.U.S.T. Midline Cortical (MC) Screw System is intended to be used as part of the M.U.S.T. Pedicle Screw system (K12115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) 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 (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K12115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).
The M.U.S.T. Midline Cortical (MC) Screw System introduce new polyaxial screws and reduction screws (solid and cannulated), developed with a focus on Midline Cortical Trajectory approach. The devices subject of this submission are:
- M.U.S.T. MC polyaxial screws Solid ●
- M.U.S.T. MC polyaxial screws Cannulated ●
- M.U.S.T. MC polyaxial reduction screws Solid ●
- M.U.S.T. MC polyaxial reduction screws Cannulated
Intended purpose and the performance specification of the devices are equivalent to the ones of the current US cleared portfolio: polyaxial screws are already used in the MUST implant construct.
The M.U.S.T. Midline Cortical (MC) Screws and the Inlay are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -Metallic materials - Part 3: Wrought titanium 6-vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); the Tulip and the Setscrew are made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials -Part 3: Wrought cobalt-chromium-molybdenum alloy, the same material of the previous cleared M.U.S.T. Pedicle Screw (K153664, K121115, K171170).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle fixation (T1-S2/ilium), non-pedicle fixation, or anterolateral fixation (78-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
- DESIGN VALIDATION
- A wetlab has been performed to validate the MUST MC implants and related instruments. The cadaver labs were performed by 3 experienced surgeons according to MUST MC surgical technique
- Geometrical Analysis MUST MC implants: To ensure that the implant has sufficient O fixation in the bone, a geometrical analysis was performed in comparison to approved and marketed implants, related to the most important dimensions of the threads.
- PERFORMANCE TESTING
- Worst Case definition for ASTM F1717 testing: discussion of implant types and sizes, chosen O as the worst case for mechanical testing of the spinal construct in a vertebrectomy model.
- Mechanical evaluation under static compression bending to ASTM F1717-18 O Standard test methods for Spinal Implants Construct in a Vertebrectomy model
- Mechanical evaluation under dynamic compression bending according to ASTM F1717-18 O Standard test methods for Spinal Implants Construct in a Vertebrectomy model
- Mechanical evaluation under static torsion according to ASTM F1717-18 Standard test о methods for Spinal Implants Construct in a Vertebrectomv model
- PYROGENICITY
- ENDOTOXINS-MEDIATED PYROGENICITY ASSESSMENT REPORT FOR: "MUST PEDICLE SCREWS IMPLANTS SURGICAL KITS" TF VI-PS-01, RAS-01.008.141 Rev. 5, Dated: October 17 2020
- ENDOTOXINS-MEDIATED PYROGENICITY ASSESSMENT FOR: "MUST MC o MODULAR TAP" TF VS-PS-01, RAS-01.008.260 Rev. 0, Dated: February 18 2020.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171170, K121115, K153664, K171758, K072022
Reference Device(s)
K12115, K132878, K141988, K153664, K162061, K171170, K171758, K193365
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.
0
April 20, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logo is simple and professional, and it is easily recognizable.
Medacta International SA % Mr. Christopher Lussier Senior Director, Quality & Regulatory Medacta USA 3973 Delp Street Memphis. Tennessee 38118
Re: K210427
Trade/Device Name: M.U.S.T. Midline Cortical (MC) Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ, KWP Dated: February 9, 2021 Received: February 11, 2021
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K210427
Device Name
M.U.S.T. Midline Cortical (MC) Screw System
Indications for Use (Describe)
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 (78-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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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
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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: February 9, 2021 Date Revised: April 12, 2021
II. Device
| Device Proprietary Name: | M.U.S.T. Midline Cortical (MC) Screw System |
|---|---|
| Common or Usual Name: | Pedicle screw spinal system |
| Classification Name: | Thoracolumbosacral pedicle screw system |
| Primary Product Code: | NKB |
| Secondary Product Code: | KWQ, KWP |
| Regulation Number: | 21 CFR 888.3070, 21 CFR 888.3060, 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. Pedicle Screw System, K171170, Medacta International SA ●
Additional predicate devices: -
M.U.S.T. Pedicle Screw System, K121115, Medacta International SA
-
M.U.S.T. Pedicle Screw System, K153664, Medacta International SA ●
-
M.U.S.T. Combined Set Screws, K171758, Medacta International SA ●
-
Valeo Pedicle Screw System, K072022, Amedica Corp.
4
IV. Device Description
The M.U.S.T. Midline Cortical (MC) Screw System is intended to be used as part of the M.U.S.T. Pedicle Screw system (K12115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) 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 (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K12115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).
The M.U.S.T. Midline Cortical (MC) Screw System introduce new polyaxial screws and reduction screws (solid and cannulated), developed with a focus on Midline Cortical Trajectory approach. The devices subject of this submission are:
- M.U.S.T. MC polyaxial screws Solid ●
- M.U.S.T. MC polyaxial screws Cannulated ●
- M.U.S.T. MC polyaxial reduction screws Solid ●
- M.U.S.T. MC polyaxial reduction screws Cannulated
Intended purpose and the performance specification of the devices are equivalent to the ones of the current US cleared portfolio: polyaxial screws are already used in the MUST implant construct.
The M.U.S.T. Midline Cortical (MC) Screws and the Inlay are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -Metallic materials - Part 3: Wrought titanium 6-vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); the Tulip and the Setscrew are made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials -Part 3: Wrought cobalt-chromium-molybdenum alloy, the same material of the previous cleared M.U.S.T. Pedicle Screw (K153664, K121115, K171170).
V. 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
5
VI. Comparison of Technological Characteristics
The new M.U.S.T. Midline Cortical (MC) Screws and the predicate devices (K153664, K12115, K171170) share the following characteristics:
- indication for use; ●
- screw shaft dimensions; ●
- screw and inlay material (Ti6Al4V ELI);
- tulip and setscrew material (CoCrMo) ●
- setscrew (cleared through K171758) ●
- through hole diameter (applicable to cannulated versions);
- biocompatibility;
- . device usage;
- sterility;
- shelf life;
- packaging. ●
The difference between the M.U.S.T. Midline Cortical (MC) Screws and the predicate devices are:
- Tulip dimensions;
- Screw thread, Spherical Head dimensions and recess.
VII. Performance Data
The introduction of the M.U.S.T. Midline Cortical (MC) Screw components into M.U.S.T. - Pedicle Screw System portfolio was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.
The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION
- o A wetlab has been performed to validate the MUST MC implants and related instruments. The cadaver labs were performed by 3 experienced surgeons according to MUST MC surgical technique
6
- Geometrical Analysis MUST MC implants: To ensure that the implant has sufficient O fixation in the bone, a geometrical analysis was performed in comparison to approved and marketed implants, related to the most important dimensions of the threads.
PERFORMANCE TESTING ●
- Worst Case definition for ASTM F1717 testing: discussion of implant types and sizes, chosen O as the worst case for mechanical testing of the spinal construct in a vertebrectomy model.
- Mechanical evaluation under static compression bending to ASTM F1717-18 o Standard test methods for Spinal Implants Construct in a Vertebrectomy model
- Mechanical evaluation under dynamic compression bending according to ASTM F1717-18 O Standard test methods for Spinal Implants Construct in a Vertebrectomy model
- Mechanical evaluation under static torsion according to ASTM F1717-18 Standard test о methods for Spinal Implants Construct in a Vertebrectomv model
- PYROGENICITY ●
- o ENDOTOXINS-MEDIATED PYROGENICITY ASSESSMENT REPORT FOR: "MUST PEDICLE SCREWS IMPLANTS SURGICAL KITS" TF VI-PS-01, RAS-01.008.141 Rev. 5, Dated: October 17 2020
- ENDOTOXINS-MEDIATED PYROGENICITY ASSESSMENT FOR: "MUST MC o MODULAR TAP" TF VS-PS-01, RAS-01.008.260 Rev. 0, Dated: February 18 2020.
Clinical Studies:
- No clinical studies were conducted. ●
Conclusion VIII.
Based on the above information, the M.U.S.T. Midline Cortical (MC) Screws are substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.