(96 days)
No
The device description focuses on mechanical components (screws, rods, connectors) for spinal fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes.
The device is indicated as an adjunct to fusion for various medical conditions, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. These indications suggest the device is used to treat or alleviate a disease or condition, which aligns with the definition of a therapeutic device.
No
This device is a pedicle screw system, described as an "adjunct to fusion" and used for "stabilization and the fusion of the lumbar and thoracic spine." These are therapeutic, not diagnostic, functions.
No
The device description clearly outlines physical implants made of titanium and CoCrMo, including screws and cross connectors, which are hardware components.
Based on the provided text, the 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, not a diagnostic one.
- Device Description: The description details the physical components of the system (screws, cross connectors, rods) and their materials. These are all physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to stabilize the spine.
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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, NKB, KWQ, KWP
Device Description
The M.U.S.T. Extension consists of the following implants that are to be used as part of the M.U.S.T. pedicle screw system (K121115):
- New sizes (diameter and length) of the solid polyaxial pedicle screws that were . cleared under K121115
- Solid and cannulated monoaxial pedicle screws .
- Cross connectors .
The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Extension includes different sizes of screws and cross connectors. The screws are fixed in the pedicle and the vertebrae. The straight and pre-bent rods (K121115) act as a connector between the different screws to create a stable construct. The cross connectors act as a stabilizing construct between the rods on each side of the vertebrae. The cross connectors have an adjustable medial/lateral length in order to address various distances between the rods depending on the patient's anatomy. Rod distances from 35mm to 98 mm can be addressed with the various connector sizes. The connector offers an angular adjustable central joint in order to align the connection to the rod. The anqular adjustable feature as well as the size range of the connectors is within the range of the predicate devices. The M.U.S.T. Extension can be applied with the common surgical technique for posterior instrumentation.
The M.U.S.T. Extension cross connectors are made of Titanium alloy (Ti6AI4V ELI -ISO 5832-3, ASTM F136) and come in 4 sizes: 35-42, 40-50, 48-66, and 64-98. The M.U.S.T. Extension pedicle screws are made of either Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or a combination of Titanium alloy (Ti6AI4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. Extension solid polyaxial pedicle screws have diameters of 8, 9, and 10mm and lengths between 20 and 100mm in 5mm increments. The M.U.S.T. Extension solid monoaxial pedicle screws have diameters between 4.5 and 7mm and lengths between 25 and 65mm in 5mm increments in addition to screws with a diameter of 8mm with lengths between 25 and 90mm. The M.U.S.T. Extension cannulated monoaxial pedicle screws have diameters between 5 and 7mm and lengths between 40 and 60mm in 5mm increments. The screw shaft is color anodized to simplify the identification of the screw diameter. The pedicle screw has a dual lead thread to simplify the screw insertion and reduce the number of turns. The threads are designed with a cylindrical diameter. The construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws are available both in sterile and unsterile packaging while the cross connectors are available in sterile packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical pedicle (T1-S2/ilium), anterolateral (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The modification to the device system to include the addition of 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 predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards. FDA quidance, and comparison to the predicate device system. The testing was conducted on the worst case component size and option/design based on engineering analysis. The M.U.S.T. Extension was compared to the worst case of the predicate devices and it was determined that the M.U.S.T. Extension are not worst case.
M.U.S.T. Extension has similar performance testing as the predicates in terms of: Static compression/bending yield strength ASTM F 1717 Fatique compression/bending strength ASTM F 1717 Static compression/bending stiffness ASTM F 1717 Static torsion vield strength ASTM F 1717 Static torsion stiffness ASTM F 1717
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121115, K083393, K042962, K091445, K072022, K041119
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.
0
K132878 Page 1 of 3
DEC 1 8 2013
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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
Mr. Adam Gross Contact Person: Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com
September 9, 2013 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: M.U.S.T. Extension Common Name: Pedicle screw spinal system Classification Name: orthosis, Spinal pedicle fixation, for degenerative disc disease
21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Class III Device Product Codes: MNI, MNH, NKB, KWQ, KWP
Predicate Devices:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K121115 | M.U.S.T Pedicle Screw System | Medacta International | 7/18/2012 |
| K083393 | XIA3 | Stryker | 4/23/2009 |
| K042962, | |||
| K091445 | CD Horizon | Medtronic | 12/14/2004, |
| 9/27/2010 | |||
| K072022 | Valeo Pedicle Screw System | Amedica | 11/19/2007 |
| K041119 | Expedium | Depuy | 7/19/2004 |
1
Product Description
The M.U.S.T. Extension consists of the following implants that are to be used as part of the M.U.S.T. pedicle screw system (K121115):
- New sizes (diameter and length) of the solid polyaxial pedicle screws that were . cleared under K121115
- Solid and cannulated monoaxial pedicle screws .
- Cross connectors .
The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Extension includes different sizes of screws and cross connectors. The screws are fixed in the pedicle and the vertebrae. The straight and pre-bent rods (K121115) act as a connector between the different screws to create a stable construct. The cross connectors act as a stabilizing construct between the rods on each side of the vertebrae. The cross connectors have an adjustable medial/lateral length in order to address various distances between the rods depending on the patient's anatomy. Rod distances from 35mm to 98 mm can be addressed with the various connector sizes. The connector offers an angular adjustable central joint in order to align the connection to the rod. The anqular adjustable feature as well as the size range of the connectors is within the range of the predicate devices. The M.U.S.T. Extension can be applied with the common surgical technique for posterior instrumentation.
The M.U.S.T. Extension cross connectors are made of Titanium alloy (Ti6AI4V ELI -ISO 5832-3, ASTM F136) and come in 4 sizes: 35-42, 40-50, 48-66, and 64-98. The M.U.S.T. Extension pedicle screws are made of either Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or a combination of Titanium alloy (Ti6AI4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. Extension solid polyaxial pedicle screws have diameters of 8, 9, and 10mm and lengths between 20 and 100mm in 5mm increments. The M.U.S.T. Extension solid monoaxial pedicle screws have diameters between 4.5 and 7mm and lengths between 25 and 65mm in 5mm increments in addition to screws with a diameter of 8mm with lengths between 25 and 90mm. The M.U.S.T. Extension cannulated monoaxial pedicle screws have diameters between 5 and 7mm and lengths between 40 and 60mm in 5mm increments. The screw shaft is color anodized to simplify the identification of the screw diameter. The pedicle screw has a dual lead thread to simplify the screw insertion and reduce the number of turns. The threads are designed with a cylindrical diameter. The construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws are available both in sterile and unsterile packaging while the cross connectors are available in sterile packaging.
2
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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Comparison to Predicate Devices
The indications for use and materials of the M.U.S.T. Extension are identical to the previously cleared predicate devices. The design features, geometries, and sizes of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the M.J.S.T. Extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Performance Testing
The modification to the device system to include the addition of 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 predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards. FDA quidance, and comparison to the predicate device system. The testing was conducted on the worst case component size and option/design based on engineering analysis. The M.U.S.T. Extension was compared to the worst case of the predicate devices and it was determined that the M.U.S.T. Extension are not worst case.
M.U.S.T. Extension has similar performance testing as the predicates in terms of: Static compression/bending yield strength ASTM F 1717 Fatique compression/bending strength ASTM F 1717 Static compression/bending stiffness ASTM F 1717 Static torsion vield strength ASTM F 1717 Static torsion stiffness ASTM F 1717
Conclusion:
Based on the above information, the M.U.S.T. Extension can be considered as substantially equivalent to its predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2013
Medacta International SA % Medacta USA Mr. Adam Gross 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K132878
Trade/Device Name: M.U.S.T. Extension Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 27, 2013 Received: September 30, 2013
Dear Mr. Gross:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Adam Gross
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Ronald Nean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132878
Device Name: M.U.S.T. Extension
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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use × (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Zane W. Wyatt -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132878
M.U.S.T. Extension 510(k)