(97 days)
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.
The M.U.S.T. pedicle screw system is intended to be used for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system is characterized by different sizes of screws and rods. The screws are fixed in the pedicle and the vertebrae. The rods act as a connector between the different screws to create a stable construct. The M.U.S.T. pedicle screw implants can be applied with the common surgical technique for posterior instrumentation. The M.U.S.T. pedicle screw implants are made of Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. pedicle screw implants consist of either cannulated or non cannulated poly-axial pedicle screws. The screws are offered with a diameter between 4.5 and 7mm and a length between 20 and 90mm. 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 pedicle screw is connected by 5.5mm Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or CoCrMo (ISO 5832-12, ASTM F 1537) rods to create a stable construct. The rods are offered straight and pre bent. The pre bent rods have a curvature of 200mm. The construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws, set screws and rods are available both in sterile and unsterile packaging.
The Medacta M.U.S.T. pedicle screw system's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Metric) | Predicate Device Performance (Reference Standard) | M.U.S.T. Pedicle Screw System Performance |
|---|---|---|
| Static Torsion Yield Torque | Met for predicate devices | Substantially equivalent |
| Static Torsion Stiffness | Met for predicate devices | Substantially equivalent |
| Static Axial Compression | Met for predicate devices | Substantially equivalent |
| Dynamic Axial Compression Performance | Met for predicate devices | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of number of screws or rods tested for the M.U.S.T. pedicle screw system. It states that "mechanical testing of the M.U.S.T. pedicle screw system included static and dynamic compression bending and static torsion according to ASTM F1717." ASTM F1717 is a standard for spinal implant testing that typically specifies the number of samples required for each test. However, the exact number used in this specific submission is not detailed.
The data provenance is from mechanical testing in a laboratory setting, not from clinical human or animal data. Therefore, there is no country of origin or retrospective/prospective designation in the human data sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device is based on engineering standards and mechanical testing results, not expert medical consensus or clinical outcomes. The "ground truth" is defined by the performance benchmarks established by the ASTM F1717 standard and the performance of legally marketed predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as the "test set" involves objective mechanical measurements against a standard, not subjective interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, and its primary evaluation for substantial equivalence is based on biomechanical performance against established standards and predicate devices, not on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense, the performance testing described is "standalone" as it focuses solely on the mechanical properties of the device itself (algorithm only, if one considers the device's design and material properties as its "algorithm") without human intervention during the actual tests of the device's mechanical strength and durability.
7. The Type of Ground Truth Used
The ground truth used is based on mechanical performance standards (ASTM F1717) and the demonstrated performance of legally marketed predicate devices. The M.U.S.T. pedicle screw system was deemed "substantially equivalent" to these predicates in terms of mechanical performance.
8. The Sample Size for the Training Set
Not applicable. This report describes the evaluation of a physical medical device (pedicle screw system) through mechanical testing, not a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's evaluation.
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K121115
page 1 of 3
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a sans-serif font, with two triangles above the "M". There is a horizontal line below the word "Medacta", and the word "International" is below the line. To the right of the word "International" is a symbol that looks like a plus sign.
JUL 18 2012
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: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: April 9, 2012
DEVICE INFORMATION
Trade/Proprietary Name: M.U.S.T. pedicle screw system 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:
K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera, Medtronic
M.U.S.T. pedicle screw system 510(k)
Section 5 - Page 2 of 4
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Product Description
The M.U.S.T. pedicle screw system is intended to be used for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system is characterized by different sizes of screws and rods. The screws are fixed in the pedicle and the vertebrae. The rods act as a connector between the different screws to create a stable construct. The M.U.S.T. pedicle screw implants can be applied with the common surgical technique for posterior instrumentation.
The M.U.S.T. pedicle screw implants are made of Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. pedicle screw implants consist of either cannulated or non cannulated poly-axial pedicle screws. The screws are offered with a diameter between 4.5 and 7mm and a length between 20 and 90mm. 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 pedicle screw is connected by 5.5mm Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or CoCrMo (ISO 5832-12, ASTM F 1537) rods to create a stable construct. The rods are offered straight and pre bent. The pre bent rods have a curvature of 200mm. The construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws, set screws and rods are available both in sterile and unsterile packaging.
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); spondvlolisthesis; 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 M.U.S.T. pedicle screw system is substantially equivalent to the predicate devices in terms of intended use, material, sizes, and biomechanical performance.
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K12///15
page 3 of 3
Performance Testing
The M.U.S.T. pedicle screw system is substantially equivalent in mechanical performance to the predicates in regards to Static Torsion Yield Torque and Stiffness, Static Axial Compression and Dynamic Axial Compression Performance. The mechanical testing of the M.U.S.T. pedicle screw system included static and dynamic compression bending and static torsion according to ASTM F1717.
Conclusion:
Based on the above information, the M.U.S.T. pedicle screw system can be considered as substantially equivalent to its predicate devices.
Section 5 - Page 4 of 4
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Medacta USA Mr. Adam Gross 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K121115
Trade/Device Name: M.U.S.T pedicle screw system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: June 22, 2012 Received: June 25, 2012
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
JUL 18 2012
{4}------------------------------------------------
Page 2 - Mr. Adam Gross
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by tions (Sections 531-542 of the Act); 21 CFR 1000-1050. product intinution von or your device on our labeling regulation (21 CFR Part 801), please n you dosite opev.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 I ba may 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,
Eunice Keith
´ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121115
Device Name: M.U.S.T. pedicle screw system
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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
M.U.S.T. pedicle screw system 510(k) June 22, 2012
Section 4 - Page 2 of 2
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.