ProMIS Fixation System

K150380 · Premia Spine, Ltd. · NKB · Jul 17, 2015 · Orthopedic

Device Facts

• Record ID: K150380
• Device Name: ProMIS Fixation System
• Applicant: Premia Spine, Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Jul 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.

Device Story

ProMIS™ Fixation System is a pedicle screw spinal system used for spinal immobilization as an adjunct to fusion. Components include polyaxial pedicle screws, fusion rods (straight or bent), and setscrews. Device is used in thoracic, lumbar, and sacral spine procedures via open or posterior percutaneous approach. Surgeons utilize MIS instrumentation, including a tower system, for percutaneous screw insertion. System provides mechanical stabilization of spinal segments to facilitate fusion. Benefits include treatment of acute/chronic instabilities and deformities. Clinical decision-making is supported by radiographic confirmation of disc degeneration and patient history.

Clinical Evidence

Bench testing only. The system underwent static compression, static torsion, and dynamic compression testing in accordance with ASTM F1717 standards.

Technological Characteristics

Components manufactured from Ti6Al4V per ASTM F136. System comprises polyaxial pedicle screws, fusion rods, and setscrews. Mechanical fixation principle. Designed for open or percutaneous insertion via tower system instrumentation. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal segment immobilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities including DDD, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and 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

• THUNDERBOLT™ and LANCER™ Pedicle Screw Systems (K132049)

Submission Summary (Full Text)

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

Premia Spine Ltd. Mr. Ron Sacher CEO 7 Giborey Israel Street Ramat Poleg, 42504 Israel

Re: K150380

Trade/Device Name: ProMIS™ Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 15, 2015 Received: June 15, 2015

Dear Mr. Sacher:

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

July 17, 2015

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## Page 2 - Mr. Ron Sacher

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 yours,

# 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) K150380

Device Name ProMIS™ Fixation System

#### Indications for Use (Describe)

The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.

Type of Use (Select one or both, as applicable)

| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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### 510(k) SUMMARY Premia Spine's ProMIS™ Fixation System

Premia Spine Ltd. 7 Giborey Israel Street Ramat Poleg, 42504, Israel

Phone: [phone] Facsimile: 972-72-2281201 Contact Person: Mr. Ron Sacher

Date Prepared: June 12, 2015

#### Trade Name: ProMIS™ Fixation System

21 C.F.R. 888.3070 Pedicle screw spinal system. NKB - orthosis, spinal pedicle fixation, for degenerative disc disease, Class III MNH - orthosis, spondylolisthesis spinal fixation, Class II MNI - orthosis, spinal pedicle fixation, Class II

#### Primary Predicate Device

1. THUNDERBOLT™ and LANCER™ Pedicle Screw Systems by Choice Spine, LP (K132049).

#### Intended Use / Indications for Use

The ProMIS™ Fixation System is intended to provide immobilization 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: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; tracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.

#### Device Description

The ProMIS™ Fixation System consists of 3 main parts:

- 1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
- 2. Polyaxial Pedicle screws.
- 3. Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136.

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#### Performance Data

The ProMIS™ Fixation System was subjected to static compression, static torsion, and dynamic compression testing per ASTM F1717.

#### Substantial Equivalence

The subject and predicate systems are made from the same materials and are composed of similar components, including pedicle screws, fusion rods, and set screws. In addition, the diameter and length range of the screws used in the subject devices are within the range of screws cleared in the predicate system. The subject devices use 6.0 mm Ti alloy rods while the predicate system uses 5.5 mm Ti alloy or CoCr rods. Finally, the ProMIS System features very similar surgical instruments compared to the predicate devices. In particular, the ProMIS, like the predicate, has surgical instruments used for percutaneous insertion of pedicle screws via a tower system.

The ProMIS™ Fixation System is substantially equivalent to the THUNDERBOLT™ and LANCER™ Pedicle Screw Systems. The ProMIS™ Fixation System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the ProMIS™ Fixation System and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the ProMIS™ Fixation System is substantially equivalent to THUNDERBOLT™ and LANCER™ Pedicle Screw Systems.

#### Conclusions

The ProMIS™ Fixation System is substantially equivalent to the predicate devices.