Sterispine™ PS

K170528 · Safe Orthopaedics · NKB · Mar 9, 2017 · Orthopedic

Device Facts

• Record ID: K170528
• Device Name: Sterispine™ PS
• Applicant: Safe Orthopaedics
• Product Code: NKB · Orthopedic
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation 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; tumor; pseudoarthrosis and failed previous fusion.

Device Story

Sterispine™ PS is a thoracolumbosacral pedicle screw system; provides spinal segment immobilization as an adjunct to fusion. System components include multiaxial screws, cannulated multiaxial screws (with/without extended heads), and straight/prebent rods. Supplied sterile with single-use surgical instruments. Used in posterior, non-cervical spinal surgery; operated by surgeons. Provides mechanical stabilization of spinal segments to facilitate fusion. Added screw lengths (65-85mm) expand existing range; mechanical properties verified via comparison to previously tested worst-case configurations.

Clinical Evidence

Bench testing only. Mechanical testing conducted on predicate devices per ASTM F1717 (static compression, static torsion, dynamic compression) and ASTM F1798 (static slipping, static bending, static rotation). Bacterial endotoxin testing performed per USP standards to meet 20 EU/device limit.

Technological Characteristics

Thoracolumbosacral pedicle screw system. Components: multiaxial/cannulated screws (Ø5.5, 6.5, 7.5mm; lengths 25-85mm) and rods (Ø5.5, 6.5, 7.5mm; lengths 30-380mm). Mechanical testing per ASTM F1717 and ASTM F1798. Supplied sterile.

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical pedicle or non-pedicle fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, 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

• Sterispine™ PS (K112453)
• Sterispine™ PS (K121299)
• Sterispine™ PS (K130632)
• Sterispine™ PS (K140802)
• Sterispine™ PS (K151747)
• Sterispine™ PS (K151921)

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

March 9, 2017 Safe Orthopaedics Mr. Pierre Dumouchel Chief Executive Officer Parc des Bellevues, Allée Rosa Luxembourg - Batiment le Californie 95160 Eragny sur Oise FRANCE

Re: K170528

Trade/Device Name: Sterispine™ PS Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: February 21, 2017 Received: February 22, 2017

Dear Mr. Dumouchel:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/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 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.

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) K170528

Device Name Sterispine™ PS

Indications for Use (Describe)

The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion.

Sterispine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation 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; tumor; pseudoarthrosis and failed previous fusion.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| 510k | Special 510k |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basis for Submission | New devices |
| Submitted by | SAFE ORTHOPAEDICS |
| | Allée Rosa Luxembourg |
| | Parc des Bellevues- Batiment le Californie |
| | 95610 - Eragny sur Oise |
| | France |
| Contacts | Pierre DUMOUCHEL- CEO |
| | [e-mail] |
| | Regulatory contact: Isabelle DRUBAIX (Idée Consulting) |
| | [e-mail] |
| Date prepared | March 7th 2017 |
| Common name | Pedicle screw spinal system |
| Trade Name | Sterispine™ PS |
| Classification name | Thoracolumbosacral Pedicle Screw System |
| Class | II |
| Product code | NKB |
| CFR section | 888.3070 |
| Device panel | Orthopedic |
| Legally marketed predicate | Primary predicate: Sterispine™ PS K112453, |
| devices | Additional predicates: Sterispine™ PS K121299, K130632, K140802, |
| | K151747, K151921) |
| Indications for use | The Sterispine™ PS system is intended to provide immobilization |
| | and stabilization of spinal segments in skeletally mature patients as |
| | an adjunct of fusion. |
| | Sterispine™ PS system is intended for posterior, non-cervica |
| | pedicle and non-pedicle fixation 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 ; tumor ; pseudoarthrosis and failed |
| | previous fusion. |
| Description of the device | The cleared range of Sterispine™ Ps system include multiaxial |
| | screws and cannulated multiaxial screws with or without extended |
| | head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 60mm) and straight |
| | and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to |
| | 380mm). Components of Sterispine™ PS range of products is |
| | supplied sterile with a sterile single-use set of surgical instruments. |
| Technological characteristics | The screw lengths added within this submission for each screw<br>diameter (Ø5.5, 6.5 and 7.5mm) is 65 to 85mm. |
| Discussion of testing | Sterispine™ PS conforms to special control established for pedicle<br>screw spinal system and to Spinal system 510(k)s- Guidance for<br>industry and FDA staff Document issued on May 3, 2004. The<br>following testing were conducted on the Sterispine™ PS predicate<br>device (K112453): Mechanical testing per ASTM F1717 standard<br>test method for spinal implant constructs in a vertebrectomy model<br>and ASTM F1798 standard guide for evaluating the static and<br>fatigue properties of interconnection mechanisms and<br>subassemblies used in spinal arthrodesis implants. Testing<br>according to ASTM F1717 includes static compression, static torsion<br>and dynamic compression. Testing according to ASTM F1798<br>includes Static slipping, static bending and static rotation. Bacterial<br>endotoxin testing as specified in USP standard is used for<br>pyrogenicity testing to achieve the Endotoxin limit of 20 EU /<br>device. These tests result have demonstrated comparable<br>mechanical properties to predicates devices.<br>It has been demonstrated that the added sizes of screws are not<br>worst cases. So, the worst case screw that has been previously<br>identified and tested (K112453, K151921). No additional risks have<br>been identified when compared with Sterispine™ PS screws<br>previously cleared. Consequently, no new additional testing was<br>needed for the added sizes. |
| Conclusion | The extended range of Sterispine™ PS system is substantially<br>equivalent to its predicate devices Sterispine™ PS (K112453,<br>K121299, K130632, K140802, K151747, K151921) in terms of<br>intended use, material, design, mechanical properties and function. |

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