Perla® Posterior Cervico-Thoracic Fixation System

K190071 · Spineart · NKG · Feb 25, 2019 · Orthopedic

Device Facts

• Record ID: K190071
• Device Name: Perla® Posterior Cervico-Thoracic Fixation System
• Applicant: Spineart
• Product Code: NKG · Orthopedic
• Decision Date: Feb 25, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from Tl-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PERLA® posterior cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

Device Story

Posterior cervico-thoracic fixation system; provides spinal stabilization/immobilization. Components include rods, hooks, multi-axial screws, set screws, rod/transverse connectors. Used in surgical settings by orthopedic/neurosurgeons. Components rigidly locked in various configurations to adapt to individual patient anatomy. Subject device modification adds 4.5mm diameter multi-axial screws to existing system. System promotes fusion; restores spinal integrity in palliative tumor cases. Connectable to ROMEO® Posterior Osteosynthesis System for extended fixation.

Clinical Evidence

No clinical data. Bench testing only, relying on engineering analysis and previously cleared predicate data (ASTM F1717, F1798, F543).

Technological Characteristics

Materials: Titanium alloy Ti6Al4V ELI (ASTM F136). Components: rods, hooks, multi-axial screws (3.5mm, 4.0mm, 4.5mm diameters), set screws, connectors. Polyaxiality: 60°. Sterilization: Gamma. Connectivity: Mechanical integration with ROMEO® system. Software: None.

Indications for Use

Indicated for patients with acute/chronic cervical (C1-C7) and upper thoracic (T1-T3) spinal instabilities requiring immobilization/stabilization as an adjunct to fusion. Includes traumatic fractures/dislocations, instability/deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for temporary spinal column restoration in patients with advanced cervical tumors where fusion is not feasible due to limited life expectancy.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• PERLA Posterior Cervico-Thoracic Fixation System (K153386)

Reference Devices

• ROMEO® Posterior Osteosynthesis System

Submission Summary (Full Text)

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February 25, 2019

SPINEART Mr. Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates Geneva, Switzerland

Re: K190071

Trade/Device Name: Perla® Posterior Cervico-Thoracic Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: January 11, 2019 Received: January 15, 2019

Dear Mr. Pennesi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Ronald P. Jean -S

for 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) K190071

#### Device Name

Perla® Posterior Cervico-Thoracic Fixation system

#### Indications for Use (Describe)

The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from Tl-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PERLA® posterior cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

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

| <div> <span> <span style="font-size:16px">☒</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> |

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# SPECIAL 510k DEVICE MODIFICATION PERLA® POSTERIOR CERVICO-THORACIC FIXATION SYSTEM

## 510(k) SUMMARY

| Type of 510k | 510k SPECIAL – DEVICE MODIFICATION |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for submission | Extension of the range of Perla® Posterior Cervico-Thoracic Fixation system |
| Submitted by | SPINEART<br>3 Chemin du Pré Fleuri<br>1228 PLAN LES OUATES<br>GENEVA SWITZERLAND |
| Contacts | Franck PENNESI Chief Technical Officer<br>Phone: [phone] Fax: [phone]<br>Mail: [e-mail]<br>Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) [e-mail] |
| Date Prepared | February 20, 2019 |
| Common Name | Orthosis, Cervical Pedicle Screw Spinal Fixation |
| Trade Name | Perla® Posterior Cervico-Thoracic Fixation system |
| Product Code | NKG / KWP |
| Class | Unclassified |
| Device panel | Orthopedic |
| Legally marketed predicate devices | Primary predicate: PERLA Posterior Cervico-Thoracic Fixation System (K153386)<br>manufactured by Spineart<br>Additional predicate: None |
| Indications for use | The PERLA® posterior cervico-thoracic fixation system is intended to provide<br>immobilization and stabilization of spinal segments as an adjunct to fusion for the<br>following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic<br>spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or<br>deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical<br>spine; and degenerative disease, including intractable radiculopathy and/or myelopathy,<br>neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and<br>degenerative disease of the facets with instability. The PERLA® posterior cervico-thoracic<br>fixation system is also intended to restore the integrity of the spinal column even in the<br>absence of fusion for a limited time period in patients with advanced stage tumors<br>involving the cervical spine in whom life expectancy is of insufficient duration to permit<br>achievement of fusion. In order to achieve additional levels of fixation, the PERLA®<br>posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior<br>Osteosynthesis System with rod connectors. Transition rods may also be used to connect<br>the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior<br>Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package<br>insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use. |
| | |
| Description of the device | The Spineart Perla® system is a posterior cervico-thoracic fixation system intended to<br>provide stabilization to promote fusion of the cervical spine and the upper thoracic spine.<br>Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws,<br>set screws, rod connectors and transverse connectors. These connecting components<br>can be rigidly locked to the rod in a variety of configurations to be adapted for the<br>individual case.<br>The multi-axial screws are available with diameters 3.5mm and 4.0 mm with lengths<br>ranging from 08 mm up to 52 mm. The purpose of this Special 510(k) application is to<br>introduce an additional range of multi-axial screw with 4.5 mm diameter and lengths<br>ranging from 08 mm up to 52 mm to the Perla® spinal system. |
| Technological<br>characteristics compared<br>to the predicate devices | The unique aspect of the new 4.5 mm multi-axial screws which differs from the existing<br>Perla® multi-axial screws is the diameter of the bone screw that is enlarged to diameter<br>4.5 mm. All other design features are strictly the same as for existing Perla® multi-axial<br>screws. Compared with previously cleared predicate multi-axial screws, the subject<br>multi-axial screws with 4.5 mm in diameter are made of the same material (Titanium<br>alloy Ti6Al4V ELI conforming to ASTM F136), available in the same lengths ranging from<br>08 mm up to 52 mm, present the same design and polyaxiality of 60° and use the same<br>set screw. Both previously cleared and new multi-axial screws are delivered sterile<br>(gamma sterilization) and supplied with the same dedicated surgical instruments<br>(reusable – provided non-sterile).<br>The following non-clinical tests were conducted on predicate devices:<br>- Static Compression Bending, Static Torsion and Dynamic Compression Bending<br>according to ASTM F1717<br>- Static flexion-extension testing, Static axial gripping and Static torsion gripping<br>according to ASTM F1798<br>- Axial pullout strength and Torque to failure according to ASTM F543<br>- Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing<br>to achieve the Endotoxin limit of 20 EU / device. |
| Discussion of Testing | An engineering analysis was performed and determined the new 4.5 mm multi-axial<br>screws do not constitute a new worst-case design in the Perla spinal system. No<br>additional testing has been performed for the Perla® 4.5 mm multi-axial screws. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons, and<br>indications for use, the Perla® 4.5 mm multi-axial screws have demonstrated substantial<br>equivalence to the identified predicate devices. |

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