M.U.S.T PEDICLE SCREW SYSTEM

K121115 · Medacta International · KWP · Jul 18, 2012 · Orthopedic

Device Facts

• Record ID: K121115
• Device Name: M.U.S.T PEDICLE SCREW SYSTEM
• Applicant: Medacta International
• Product Code: KWP · Orthopedic
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

M.U.S.T. pedicle screw system provides spinal stabilization and fusion; consists of cannulated or non-cannulated poly-axial pedicle screws, rods, and set screws. Screws feature dual lead threads for simplified insertion; color-anodized shafts for diameter identification. Implants are surgically implanted by physicians using standard posterior instrumentation techniques. Rods connect screws to create stable construct. System components are available in sterile or unsterile packaging. Device provides mechanical support to the spine to facilitate fusion in patients with degenerative or traumatic spinal conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance evaluated via static and dynamic compression bending and static torsion testing in accordance with ASTM F1717.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V ELI, ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F1537). Components: Poly-axial pedicle screws (4.5-7mm diameter, 20-90mm length), 5.5mm rods (straight/pre-bent), and set screws. Features: Dual lead thread, color-anodized screw shafts. Sterilization: Available in sterile or unsterile packaging.

Indications for Use

Indicated for skeletally mature patients requiring posterior non-cervical (T1-S2/ilium) or anterolateral (T8-L5) spinal fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

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.

Predicate Devices

• CD Horizon (K091445)
• CD Horizon (K042962)
• USS (K022949)
• Matrix (K100952)
• Valeo (K072022)
• Optima (K024096)
• Expedium (K041119)
• XIA 3 (K083393)
• Solera (K101074)
• Solera (K113174)

Submission Summary (Full Text)

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K121115
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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 [phone] Fax [phone]

Contact Person: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: [phone] Fax: [phone] Email: [e-mail]

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

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# 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 [phone] or [phone] 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)

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(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

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