PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
Applicant
Spineart
Product Code
NKG · Orthopedic
Decision Date
May 1, 2020
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3075
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the crania-cervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to 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 occipito-cervico-thoracic fixation system is 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. The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (C1 to C7) and the thoracic spine (T1 to T3). In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA® TL Posterior Osteosynthesis Systems with rod connectors. Transition rods may also be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for skeletally mature patients.
Device Story
PERLA® system is a posterior occipito-cervico-thoracic fixation system; comprises screws, rods, set screws, hooks, rod connectors, and cross-connectors. Used by surgeons in clinical settings to provide spinal immobilization/stabilization. Components rigidly lock to rods to adapt to individual patient anatomy. System connects to ROMEO®2 and PERLA® TL systems via rod connectors/transition rods. Provides mechanical support to spinal column; facilitates fusion or restores integrity in tumor cases. Benefits include stabilization of unstable spinal segments and pain relief from degenerative conditions.
Clinical Evidence
Bench testing only. Non-clinical mechanical testing performed: static compression bending, static torsion, dynamic compression bending, and dynamic torsion per ASTM F2706-18. Results demonstrate mechanical properties comparable to predicate devices. Bacterial endotoxin testing performed per USP standards.
Technological Characteristics
Materials: medical grade titanium alloy (ASTM F136) and medical grade cobalt chromium (ASTM F1537). Components: occipital plates, screws, rods, transition rods, rod-to-rod connectors. Sterilization: gamma sterilization for sterile-supplied implants; reusable instruments provided non-sterile (except drill). Endotoxin limit: 20 EU/device.
Indications for Use
Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for acute/chronic instabilities of crania-cervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3). Conditions include traumatic fractures/dislocations, instability/deformity, failed fusions, cervical tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in advanced cervical tumor patients 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
Mountaineer OCT, Summit SI OCT Spinal Fixation System (K110353, K151885)
Neon3T™ Universal OCT Spinal Stabilization (K161032)
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May 1, 2020
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SPINEART Mr. Franck Pennesi Chief Technical Officer 3 Chemin du Pre Fleuri 1228 Plan Les Quates Geneva, Switzerland
Re: K200571
Trade/Device Name: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: March 3, 2020 Received: March 4, 2020
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/cdrh/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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
### K200571
Device Name
PERLA® posterior occipito-cervico-thoracic fixation system
#### Indications for Use (Describe)
The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the crania-cervical junction. the cervical spine (Cl to C7) and the thoracic 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 occipito-cervico-thoracic fixation system is 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.
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (Cl to C7) and the thoracic spine (Tl to T3).
In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA® TL Posterior Osteosynthesis Systems with rod connectors. Transition rods mav also be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for skeletally mature patients.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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## Traditional 510k
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# 510(k) SUMMARY
| 510k | TRADITIONAL |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basis for submission | New devices |
| 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: +41 22 570 1200 Fax: +41 22 594 8306<br>Mail: fpennesi@spineart.com<br>Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr |
| Date Prepared | February 27, 2020 |
| Common Name | Pedicle screw spinal system |
| Trade Name | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System |
| Classification Name | Posterior cervical screw system |
| Class | II |
| Product Code | NKG, KWP |
| CFR section | 888.3075 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate: Mountaineer OCT, Summit SI OCT Spinal Fixation System manufactured by Depuy Synthes, Inc (K110353, K151885)<br>Additional predicates: Neon3T™ Universal OCT Spinal Stabilization manufactured by Ulrich Gmbh & CO. KG (K161032); Vertex Reconstruction System manufactured by Medtronic Sofamor Danek USA, Inc (K143471); Tiger Occipital-Cervical-Thoracic Spinal Fixation System manufactured by Corelink LLC (K132504); Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System manufactured by Pioneer Surgical Technology, Inc (K121725); Oasys Spinal System manufactured by Stryker Spine (K111719) |
| Indications for use | The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the crania-cervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to 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.<br>The PERLA® posterior occipito-cervico-thoracic fixation system is 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 |
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| spine in whom life expectancy is of insufficient duration to permit achievement of<br>fusion. | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The occipital bone screws are limited to occipital fixation only. The use of the<br>multi-axial screws is limited to placement in the cervical spine (C1 to C7) and the<br>thoracic spine (T1 to T3). | |
| In order to achieve additional levels of fixation, the PERLA® posterior occipito-<br>cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA®<br>TL Posterior Osteosynthesis Systems with rod connectors. Transition rods may also<br>be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system<br>to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the<br>ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a<br>list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications<br>of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for<br>skeletally mature patients. | |
| Description of the<br>device | The PERLA® system consists of a range of screws, rods, set screws, hooks, rod<br>connectors and cross-connectors. These connecting components can be rigidly<br>locked to the rod in a variety of configurations to be adapted for the individual<br>case. The PERLA® system is manufactured from medical grade titanium alloy and<br>medical grade cobalt chromium conforming respectively to standards ASTM F136<br>and ASTM F1537. The PERLA® implants are delivered either non sterile or sterile<br>(gamma sterilization) and supplied with dedicated surgical instruments (reusable<br>- provided non-sterile except for the drill supplied as sterile or not sterile).<br>Bacterial endotoxin testing on final, finished devices as specified in USP standard<br>is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. |
| Technological<br>characteristics<br>compared to<br>the<br>predicate devices | The subject product line extension of the PERLA® Posterior Cervico-Thoracic<br>Fixation System (K153386, K190071) consists of implants for occipital fixation. The<br>line extension includes occipital plates, occipital screws, occipital rods, occipital<br>adjustable rods, transition rods and rod to rod connectors. As was established in<br>this submission, the PERLA® components for occipital fixation are substantially<br>equivalent and have the same technological characteristics to predicate devices in<br>areas including indications for use, function, material composition, design, range<br>of sizes and mechanical performance. |
| Discussion of Testing | The following non-clinical tests were conducted on the PERLA® components for<br>occipital fixation: Static Compression bending, Static Torsion, Dynamic<br>Compression bending and Dynamic Torsion per ASTM F2706-18. Results<br>demonstrate comparable mechanical properties to the predicate devices. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons,<br>indications for use, and non-clinical performance testing, the PERLA® components<br>for occipital fixation have demonstrated substantial equivalence to the identified<br>predicate devices. |
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