(29 days)
K12115, K132878
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a pedicle screw system, is designed for spinal fixation and fusion to treat various medical conditions, indicating a therapeutic purpose.
No
The device is a pedicle screw system used for surgical fixation and fusion of the spine, not for diagnosing medical conditions.
No
The device description clearly details physical components made of materials like Ti6Al4V ELI, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation and fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and extensions made of materials like Ti6Al4V ELI and CoCrMo. These are all components of a surgical implant system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. The device's function is mechanical stabilization of the spine.
- Performance Studies: The performance studies described are mechanical tests (static compression/bending, dynamic compression/bending, static torsion), which are relevant to the structural integrity of a surgical implant, not the accuracy of a diagnostic test.
In summary, the M.U.S.T. Pedicle Screw System is a surgical implant intended for the treatment of spinal conditions, not for diagnosing them.
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) 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.
Product codes
NKB, MNI, MNH, KWQ, KWP
Device Description
The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system (K12115, K132878, K141988) 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), cannulated or non cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K12115), and cross connectors (K132878). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).
This Special 510(k) introduces a new design of the pedicle screw head (Tulip). The new design features two additional tabs in order to perform the rod reduction with the setscrew. The tulip has also changed materials from to CoCrMo to Ti6Al4V ELI.
The size range of the modified Pedicle Screws introduced with this 510(k) is the same as the predicate devices.
The M.U.S.T. Extension consists of the following components, which are all provided in both sterile and unsterile packaging:
Solid Poly-Axial Pedicle Screws: Diameter 4.5, 5, 6, 7mm, Length 20-90mm, Material Ti6Al4V ELI (ISO 5832-3 ASTM F 136)
Cannulated Poly-Axial Pedicle Screws: Diameter 5, 6, 7mm, Length 25-90mm, Material Ti6Al4V ELI (ISO 5832-3 ASTM F 136)
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) or 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 modification to the device system to include the addition of the M.U.S.T. Extension 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 pre-defined 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 mechanical tests, per ASTM F 1717, were performed on the device:
- Static compression/bending strength ASTM F 1717
- Dynamic compression/bending strength ASTM F 1717
- Static torsion strength ASTM F 1717
The device's behavior and performance can be considered equivalent to its predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K12115, K132878
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Medacta International Michael G. Loiterman. MPD. RAC. CCEP Director - Quality, Regulatory and Compliance Medacta USA 1556 West Carroll Avenue Chicago, Illinois 60607
Re: K153664
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: December 18, 2015 Received: December 21, 2015
Dear Mr. Loiterman:
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/Resourcesfor You/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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K153664
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) 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 FF
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Image /page/4/Picture/0 description: The image shows the logo for Medacta International. The logo consists of two blue triangles pointing upwards, followed by the word "Medacta" in blue. Underneath the word "Medacta" is a yellow line, and below that is the word "International" in a smaller font size. To the right of the word "International" is a red square with a white cross in the center.
510(k) Summary
- Applicant/Sponsor: Medacta International Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
- Contact Person: Michael G. Loiterman, MPD, RAC, CCEP Director - Quality, Regulatory and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: 312-548-9971 Fax: 312-546-6881 Email: mloiterman@medacta.us.com
Date Prepared: December 18, 2015
DEVICE INFORMATION
Trade/Proprietary Name: M.U.S.T. Pedicle Screw System Common Name: Pedicle screw spinal system Classification Name: Pedicle screw spinal system 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Class III Device Product Codes: NKB, MNI, MNH, KWQ, KWP
Predicate Device(s):
Primary Predicate
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K121115 | M.U.S.T. Pedicle Screw System | Medacta International | 7/18/2012 |
Additional Predicate
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K141988 | M.U.S.T. Pedicle Screw System | Medacta International | 8/1914 |
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Product Description
The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system (K12115, K132878, K141988) 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), cannulated or non cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K12115), and cross connectors (K132878). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).
This Special 510(k) introduces a new design of the pedicle screw head (Tulip). The new design features two additional tabs in order to perform the rod reduction with the setscrew. The tulip has also changed materials from to CoCrMo to Ti6Al4V ELI.
The size range of the modified Pedicle Screws introduced with this 510(k) is the same as the predicate devices.
The M.U.S.T. Extension consists of the following components, which are all provided in both sterile and unsterile packaging:
| Component | Diameter | Length | Material |
|---|---|---|---|
| Solid Poly-Axial | |||
| Pedicle Screws | 4.5, 5, 6, 7mm | 20-90mm | Ti6Al4V ELI (ISO 5832-3 ASTM F 136) |
| Cannulated Poly-Axial | |||
| Pedicle Screws | 5, 6, 7mm | 25-90mm | Ti6Al4V ELI (ISO 5832-3 ASTM F 136) |
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Indications for Use
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adiunct 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.
Comparison to Predicate Devices
The indications for use, design features and materials of the M.U.S.T. Extension are substantially equivalent to those of the predicate devices. The substantial equivalence of the M.U.S.T. Extension implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.
Performance Testing
The modification to the device system to include the addition of the M.U.S.T. Extension 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 pre-defined 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 mechanical tests, per ASTM F 1717, were performed on the device:
-
- Static compression/bending strength ASTM F 1717
-
- Dynamic compression/bending strength ASTM F 1717
-
- Static torsion strength ASTM F 1717
The device's behavior and performance can be considered equivalent to its predicate.
Conclusion:
Based on the above information, the M.U.S.T. Extension can be considered as substantially equivalent to its predicate devices.