Erisma® LP MIS

K162367 · Clariance, Sas · NKB · Oct 27, 2016 · Orthopedic

Device Facts

• Record ID: K162367
• Device Name: Erisma® LP MIS
• Applicant: Clariance, Sas
• Product Code: NKB · Orthopedic
• Decision Date: Oct 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Erisma® LP MIS is a pedicle screw spinal system for percutaneous, posterior, non-cervical spinal fixation; used as an adjunct to fusion. System comprises cannulated extended pedicle screws and rods; designed for stabilization of thoracic, lumbar, and sacral spinal segments. Operated by surgeons in clinical settings; provides immobilization of spinal segments to treat instabilities or deformities. Primary design feature is extended break-off tabs on pedicle screws to facilitate minimally invasive surgical (MIS) access. Device components are implanted to restore spinal stability; surgeon selects appropriate diameters and lengths based on patient anatomy. Benefits include reduced surgical invasiveness compared to traditional open approaches while maintaining equivalent fixation performance.

Clinical Evidence

Bench testing only. Performance data includes dynamic ASTM F1717 testing and sterilization validation to demonstrate substantial equivalence.

Technological Characteristics

Materials: Medical grade Titanium alloy (ISO 5832-3 or ASTM F136). Components: Cannulated extended pedicle screws, straight/pre-bent rods, and surgical instruments. Form factor: MIS-compatible with break-off tabs. Sterilization: Validated. Energy source: None (mechanical).

Indications for Use

Indicated for skeletally mature patients requiring percutaneous, posterior, non-cervical pedicle fixation for degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, severe spondylolisthesis (Grades 3-4, L5-S1), fracture, dislocation, scoliosis, kyphosis, spinal tumor, or pseudarthrosis.

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

• Erisma LP Spinal Fixation System (K153326)
• ES2 Spinal System (K122845)

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

October 27, 2016

CLARIANCE SAS % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K162367

Trade/Device Name: Erisma® LP MIS Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: August 23, 2016 Received: August 23, 2016

Dear Ms. Hogan:

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 Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

#### K162367

Device Name: Erisma® LP MIS

#### Indications for Use

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).

Type of Use

区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

_ Over-The-Counter Use (21 CFR 801

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☐ Over-The-Counter Use (21 CFR 801

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# 510(k) SUMMARY

# Erisma® LP MIS

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

# CLARIANCEÁIœÙ

18 rue Robespierre

F-62217 Beaurains, FRANCE

Phone: [phone] Facsimile: [phone]

Contact Person: Pascal Rokegem, Chief Technology Officer

Date Prepared: October 25, 2016

# Name of Device and Name/Address of Sponsor

Erisma® LP MIS

## Common or Usual Name

Non cervical Minimal Invasive Pedicle Spinal System

## Classification Name

Pedicle Screw Spinal System

Class III, 21 CFR 888.3070 - NKB, MNH and MNI

## Predicate Devices

Erisma LP Spinal Fixation System Manufactured by CLARIANCE SAS (K153326) (Primary predicate device)

ES2 Spinal System Manufactured by STRYKER Spine (K122845) (Additional predicate device)

## Indications for Use

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:

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- 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).

# Technological Characteristics

The Erisma® LP MIS device is intended to be used 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 Erisma® LP MIS also contains surqical instruments common for posterior percutaneous spinal fixation approach. The primary purpose of this submission is to extend the breakoff tabs of the pedicle screws to allow for minimally invasive surgery. The documentation provided demonstrates that the Erisma® LP MIS is substantially equivalent to the predicate devices in terms of material, design and indications for use.

## Performance Data

Bench Testing was performed to establish equivalence including:

- Dynamic ASTM F1717 testing ●
- Sterilization validation

## Substantial Equivalence

The Erisma® LP MIS device has the same intended use and indications, as well as very similar principles of operation and technological characteristics to the cleared company's Erisma® LP (K153326) and the Stryker Spine ES2 Spinal System (K122845) predicate

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devices. The primary change to the system is the extension of the breakable tabs to allow for MIS insertion, which is technologically similar to the Stryker Spine ES2 Spinal System. These changes do not raise different safety or effectiveness questions. Performance data demonstrates that the Erisma® LP MIS is substantially equivalent to its predicate devices.

# Conclusions

The Erisma® LP MIS is substantially equivalent to the predicate devices.