When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); degenerative spondylolisthesis with objective evidence of neurologic impairment; severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; fracture; dislocation; scoliosis; kyphosis; spinal tumor; failed previous fusion (pseudarthrosis)

The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
· Degenerative spondylolisthesis with objective evidence of neurologic impairment,
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint,
· Fracture,
· Dislocation,
· Scoliosis,
· Kyphosis,
· Spinal tumor,
· Failed previous fusion (pseudarthrosis).

Device Description

The modified Erisma® Lp Spinal Fixation System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System device (K240872). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, Offset Connectors, screw sets and associated instruments. Further, the implants used in the cleared Erisma® Lp Spinal Fixation System device and modified Erisma® Lp Spinal Fixation System are both made of Ti6Al4V alloy per ASTM F136.

The modified Erisma® LP MIS is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® LP MIS device (K162367). The Erisma® LP MIS device is indicated for the surgical treatment of spinal pathologies by percutaneous access. The treatment consists of the stabilization of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The Erisma® LP MIS consists of cannulated extended pedicle screws and straight or pre-bent rods that can be used via posterior percutaneous surgical approach to provide the immobilization and the stabilization of spinal segments in mature patients as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar and sacral spine. The components are available in a variety of diameters and lengths to accommodate patient anatomy and are made from ISO 5832-3 or ASTM F136 medical grade Titanium alloy.

The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System and the Erisma® LP MIS, with the addition of new components: 'Uniplanar Screws'

AI/ML Overview

The provided text describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered device. Therefore, it does not contain the specific information requested about acceptance criteria and studies related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence to predicate devices for a modified Erisma® Lp Spinal Fixation System and Erisma® LP MIS. The performance data presented are for mechanical tests, not clinical studies involving AI or human interpretation.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not for an AI/ML powered medical device.

The "Performance Data" section explicitly states: "Dynamic compression bending test and Static torsion mechanical verification test according to ASTM F1717 and static torsional grip test according to ASTM F1798 were performed to characterize the subject modification addressed in this notification." These are mechanical tests for a physical implant, not a study of an AI algorithm's diagnostic or predictive capabilities.

Summary

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July 24, 2024

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Clariance % Magalie Hennequin Quality & Regulatory Affairs & Clinical Director Clariance Inc. 42547 Farrington Street Dallas. Texas 75207

Re: K241863

Trade/Device Name: Erisma® Lp Spinal Fixation System; Erisma® LP MIS Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 24, 2024 Received: June 27, 2024

Dear Magalie Hennequin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

Image /page/1/Picture/5 description: The image shows a signature block with the word "Sincerely" at the top. Below that is the name "Eileen Cadel - S". To the right of the name is a digital signature block that states the document was digitally signed by Eileen Cadel on July 24, 2024, at 08:30:16 -04'00".

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K241863

Device Name Erisma® Lp Spinal Fixation System; Erisma® LP MIS

Indications for Use (Describe)

When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); degenerative spondylolisthesis with objective evidence of neurologic impairment; severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; fracture; scoliosis; kyphosis; spinal tumor; failed previous fusion (pseudarthrosis)

The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

· Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

· Degenerative spondylolisthesis with objective evidence of neurologic impairment,
· Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint.
· Fracture,
· Dislocation,
· Scoliosis,
· Kyphosis,
· Spinal tumor,
· Failed previous fusion (pseudarthrosis).

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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510(K) SUMMARY

Erisma® LP Spinal Fixation System Erisma® LP MIS

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CLARIANCE SAS 18, rue Robespierre 62217 Beaurains, France

Phone: +33(0)3 2116 1215 Facsimile: +33(0)3 2115 5073

Contact Person: Magalie HENNEQUIN, Quality & Requlatory Affairs & Clinical Director. Consultant: Magalie HENNEQUIN, Quality & Regulatory Affairs & Clinical Director Date Prepared: May 27th, 2024.

Name of Device:

Erisma® Lp Spinal Fixation System Erisma® LP MIS

Common or Usual Name:

Thoracolumbosacral pedicle screw system

Classification Name:

Class II, 21 CFR 888.3070 - NKB

Predicate Devices

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (K240872) Primary predicate.

Erisma® LP MIS (K162367) Additional predicate

Device Description

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Fixation System device and modified Erisma® Lp Spinal Fixation System are both made of Ti6Al4V alloy per ASTM F136.

The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System and the Erisma® LP MIS, with the addition of new components: 'Uniplanar Screws'

Intended Use / Indications for Use

Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
· Degenerative spondylolisthesis with objective evidence of neurologic impairment,
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint,
· Fracture,
· Dislocation,
· Scoliosis,
· Kyphosis,
· Spinal tumor,
· Failed previous fusion (pseudarthrosis).

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Summary of Technological Characteristics

The modified Erisma® Lp Spinal Fixation System and the modified Erisma® LP MIS devices possess the same technological characteristics as the predicate devices. No changes have been made as part of this submission. The fundamental scientific technology of the subject devices remains unchanged.

Performance Data

Dynamic compression bending test and Static torsion mechanical verification test according to ASTM F1717 and static torsional grip test according to ASTM F1798 were performed to characterize the subject modification addressed in this notification.

Conclusions

The modified Erisma® Lp Spinal Fixation System is substantially equivalent to the cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System device (K240872) and the cleared Erisma® LP MIS (K162367).

The modified Erisma® Lp Spinal Fixation System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Performance data demonstrate that the subject devices are substantially equivalent to the already cleared Erisma® Deformity Spinal System: Erisma® Lp Spinal Fixation System device (K240872) and the cleared Erisma® LP MIS (K162367). Thus, the modified Erisma® Lp Spinal Fixation System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.