CALYPSO SYSTEM

K120564 · Hogan Lovells US LLP · NKB · Jul 16, 2012 · Orthopedic

Device Facts

• Record ID: K120564
• Device Name: CALYPSO SYSTEM
• Applicant: Hogan Lovells US LLP
• Product Code: NKB · Orthopedic
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (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, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

Device Story

Posterior spinal fixation system; provides immobilization and stabilization of thoracic, lumbar, and sacral spine segments. Components include monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. Used by surgeons in clinical/OR settings to treat degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, pseudoarthrosis, or failed fusion. Implants provide mechanical support to facilitate spinal fusion. Device is implanted surgically; provides rigid fixation to stabilize spinal segments during healing process.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1798 and ASTM F1717 (static axial gripping, flexion/extension, compression bending, torsion, dynamic compression). Biocompatibility confirmed per ISO 10993. Sterilization and shelf life validated per ISO 11137, ISO 17665, and ASTM 1980.

Technological Characteristics

Posterior spinal instrumentation system. Materials: Ti6Al4V titanium alloy (ISO 5832-3). Components: monoaxial/polyaxial pedicle screws, union rods, transverse connectors, hooks. Mechanical testing standards: ASTM F1798, ASTM F1717. Biocompatibility: ISO 10993. Sterilization: ISO 11137, ISO 17665.

Indications for Use

Indicated for skeletally mature patients requiring immobilization/stabilization of thoracic, lumbar, or sacral spine as adjunct to fusion. Conditions: degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed fusion revision. Posterior, non-cervical application.

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

• Aesculap Implant Systems, Inc.'s S4 Spinal System (K100623)
• Medtronic Sofamor Danek USA, Inc.'s CD HORIZON Spinal System (K113174)

Submission Summary (Full Text)

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## 510(k) SUMMARY

### lmplanet S.A.'s Calypso System

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

Implanet S.A. Technopole Bordeaux Montesquieu Allée Francois Magendie 33650 Martillac France Phone: [phone] Facsimile: [phone]

Contact Person: Franck Rigal, Director of Quality and Regulatory Affairs

Date Prepared: July 12, 2012

### Name of Device

Calypso System

#### Common or Usual Name

Spinal fixation device

#### Classification Name

888.3070 - Pedicle Screw Spinal System

888.3050 - Spinal interlaminal fixation orthosis

### Predicate Devices

Aesculap Implant Systems, Inc.'s S4 Spinal System (K100623)

Medtronic Sofamor Danek USA, Inc.'s CD HORIZON Spinal System (K113174)

#### Intended Use / Indications for Use

The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (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, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

JUL 16 2012

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## Technological Characteristics

The Calypso System is a posterior instrumentation system consisting of monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. The implants in the system are composed of Ti6Al4V titanium alloy described by ISO 5832-3.

## Performance Data

In support of this 510(k) Premarket Notification, Implanet S.A. has conducted bench testing to demonstrate that the Calypso System provides adequate mechanical strength for its intended use. All bench testing confirmed that the product met the necessary specifications. In addition, the biocompatibility of the device has been confirmed in accordance with ISO-10993, and the company has conducted sterilization and shelf life validation in accordance with recognized industry standards. A list of the tests performed to support substantial equivalence is provided below:

- Static axial gripping capacity, static flexion/extension bending, static axial torque gripping . capacity- ASTM F1798
- Static compression bending ASTM F1717 .
- Static torsion ASTM F1717 .
- Dynamic compression bending ASTM F1717 ●
- Cytotoxicity ISO 10993 ●
- Acute systemic toxicity ISO 10993 ●
- . Shelf life - ASTM 1980
- Implant sterilization validation ISO 11137 ●
- Instrument cleaning and sterilization validation ISO 17665

## Substantial Equivalence

The Calypso System is very similar to the Aesculap Implant Systems, Inc.'s S4 Spinal System and Medtronic Sofamor Danek USA, Inc.'s CD HORIZON Spinal System. The Calypso System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Calypso System and its predicate devices raise no new issues of safety or effectiveness. Performance data, including mechanical testing in static compression bending, static torsion, and dynamic compression bending, as well as biocompatibility and sterility testing, demonstrate that the minor differences between the Calvoso System and the predicates do not adversely impact its performance. Thus, the Calypso System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

Re: K120564

Trade/Device Name: Calypso System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: June 21, 2012 Received: June 21, 2012

JUL 16 2012

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

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Page 2 - Ms. Janice Hogan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

K120564 510(k) Number (if known):_

Device Name: Calypso System

Indications for Use:

The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (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 deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Oil) Division of Surgical, Orthopedic, and Restorative Devices

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KI20564 10(k) Number_

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