Santis Pedicle Screw System

K150507 · Lanterna Medical Technologies · NKB · Apr 3, 2015 · Orthopedic

Device Facts

• Record ID: K150507
• Device Name: Santis Pedicle Screw System
• Applicant: Lanterna Medical Technologies
• Product Code: NKB · Orthopedic
• Decision Date: Apr 3, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Santis Pedicle Screw System is intended for immobilization of the spine. The Santis Pedicle Screw System is indicated for posterical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Story

Santis™ Pedicle Screw System is a spinal fixation implant system consisting of straight/pre-curved rods, cannulated/non-cannulated pedicle screws, compression retaining assemblies, cross connectors, and set screws. Used for spinal immobilization and stabilization as an adjunct to fusion. Implanted via open or percutaneous MIS surgical approaches by surgeons. System components are available in various sizes to accommodate patient-specific pathology. The device provides mechanical stabilization to the spine to facilitate fusion. This specific submission serves to clear the previously cleared device as a sterile, packaged product.

Clinical Evidence

Bench testing only. Validation included package integrity (ASTM F1886-09, F1929-12, D3078, F2096), gamma sterilization (ANSI/AAMI/ISO 11137 and 11607), shelf life (ASTM F1980), and shipping validation (ASTM D4169). All tests passed.

Technological Characteristics

Components constructed from Ti6Al4V ELI (ASTM F136) or cobalt chrome (ASTM F1537). System includes rods, pedicle screws (cannulated/non-cannulated), compression assemblies, cross connectors, and set screws. Sterile, gamma-sterilized, packaged device.

Indications for Use

Indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Santis™ Pedicle Screw System (K133063)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 3, 2015

Lanterna Medical Technologies % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K150507

Trade/Device Name: Santis™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 23, 2015 Received: March 24, 2015

Dear Dr. Jansen:

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

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Page 2 - Rich Jansen, Pharm.D.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150507

Device Name Santis Pedicle Screw System

#### Indications for Use (Describe)

The Santis Pedicle Screw System is intended for immobilization of the spine. The Santis Pedicle Screw System is indicated for posterical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> <span style="font-size:16px">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> <span style="font-size:16px">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

| Date Prepared:<br>Submitter | March 10, 2015<br>Lanterna Medical Technologies<br>Horace Hale, President<br>Postfach 231<br>Rorschacherstrasse 294<br>St. Gallen, Switzerland, 9016<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Rich Jansen, Pharm. D.<br>Silver Pine Consulting<br>[e-mail] |
| Device:<br>Product Class:<br>Classification:<br>Common Name:<br>Product Codes:<br>Panel Code: | Santis™ Pedicle Screw System<br>Class III<br>21 CFR §888.3070 Pedicle Screw Spinal System<br>Pedicle Screw System<br>NKB, MNI, MNH<br>87 |

Purpose: The purpose of this submission is to gain clearance of previously cleared devices as sterile, packaged products.

Predicate Device(s): The primary predicate device is the Santis™ Pedicle Screw System (K133063)

### Device Description:

The Santis™ Pedicle Screw System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis™ Pedicle Screw System can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure.

Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.

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## Indications for Use:

The Santis™ Pedicle Screw System is intended for immobilization and stabilization of the spine. The Santis™ Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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.

# Technological Characteristics:

The technological characteristics of the subject device and the predicate device are summarized below.

| | Subject Device |
|-------------------------|-------------------|
| Indications for Use | Same as predicate |
| Surgical Technique | Same as predicate |
| Screw Options and sizes | Same as predicate |
| Cross Connectors | Same as predicate |
| Rod sizes | Same as predicate |
| Materials | Same as predicate |

# Performance Standards:

Performance testing includes:

| Validation | Standard | Pass/Fail |
|---------------------|-------------------------------------|-----------|
| Package integrity | F1886-09, F1929-12, D3078 and F2096 | Passed |
| Gamma sterilization | ANSI/AAMI/ISO 11137 and 11607 | Passed |
| Shelf life | ASTM F1980 | Passed |
| Shipping validation | ASTM D4169 | Passed |

# Conclusion:

Lanterna Medical Technologies concludes that the Santis™ Pedicle Screw System is substantially equivalent to the previously cleared Santis™ Pedicle Screw System. The packaging and sterilization processes have been validated and raise no new questions of safety or effectiveness.