JAZZ System, including JAZZ Band

K170730 · Implanet, S.A. · OWI · Jun 9, 2017 · Orthopedic

Device Facts

• Record ID: K170730
• Device Name: JAZZ System, including JAZZ Band
• Applicant: Implanet, S.A.
• Product Code: OWI · Orthopedic
• Decision Date: Jun 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinaldeformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis; - 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium-molybenum alloy whenever "wiring" may help secure the attachment of other implants.

Device Story

JAZZ System is a temporary orthopedic implant used as a bone anchor for stabilization during bony fusion or fracture repair. Components include JAZZ Band (braid), buckle, connectors, hooks, and rods. Used in spinal surgery (trauma, reconstruction, degenerative) by surgeons to secure implants via sublaminar or facet wiring techniques. The device functions by anchoring to bone and connecting to other titanium or cobalt-chromium-molybdenum alloy implants. The modification involves changes to the ultrasonic welding of the braid and the metal buckle design. The system provides mechanical stabilization to assist in spinal deformity correction and fusion.

Clinical Evidence

Bench testing only. Static tensile testing and biocompatibility assessment per ISO 10993 were performed to compare the modified JAZZ Band to the predicate device.

Technological Characteristics

Temporary orthopedic bone fixation system. Components include braid (band), buckle, connectors, hooks, and rods. Materials include titanium alloy and cobalt-chromium-molybdenum alloy. Mechanical fixation via ultrasonic welding of the braid and metal buckle tightening. Non-software device.

Indications for Use

Indicated for patients undergoing spinal trauma, reconstructive, or degenerative surgery requiring temporary stabilization as a bone anchor or adjunct to spinal fusion. Applications include sublaminar/facet wiring, correction of spinal deformities (adolescent idiopathic scoliosis, adult scoliosis, kyphosis, spondylolisthesis), and fracture repair.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Implanet's JAZZ System (K151740)
• Implanet's JAZZ Systems (K162764)
• Implanet's JAZZ Lock (K153348)

Submission Summary (Full Text)

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Public Health Service

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

June 9, 2017

Implanet, S.A. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, Pennsylvania 19103

Re: K170730

Trade/Device Name: JAZZ System, including JAZZ Band Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: April 3, 2017 Received: April 3, 2017

Dear Janice 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

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K170730

Device Name JAZZ System, including JAZZ Band

Indications for Use (Describe)

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

- Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinaldeformities such as adolescent 2. idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- ന് Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium-molybenum alloy whenever "wiring" may help secure the attachment of other implants.

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

| <div> <span style="font-size: 10pt"> <span style="font-family: Symbol"> <span> </span> </span> <span style="font-family: Calibri, sans-serif"> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </div> |
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| <div> <span style="font-size: 10pt"> <span style="font-family: Symbol"> <span> </span> </span> <span style="font-family: Calibri, sans-serif"> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </div> |

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## 510(k) SUMMARY Implanet's JAZZ System. including JAZZ Band K170730

#### 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: Regis Le Couedic, Director of Quality and Regulatory Affairs; Chief Technology Officer

Date Prepared: June 8, 2017

#### Application Correspondent:

Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: [phone]

#### Name of Device:

JAZZ System, including JAZZ Band

#### Common or Usual Name:

Bone, Fixation, Cerclage, Sublaminar

#### Classification Name:

Bone, Fixation, Cerclage

#### Primary Product Code

OWI

## Regulation Number

21 CFR § 888.3010

#### Device Class

Class II

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## Predicate Devices

Implanet's JAZZ System (K151740) (primary)

Implanet's JAZZ Systems (K162764) (additional)

Implanet's JAZZ Lock (K153348) (additional)

## Device Description

The JAZZ Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.

## Intended Use/Indications for Use

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

- 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinaldeformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis:
- 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ System may also be used in coniunction with other medical implants made of titanium alloy or cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.

## Purpose of 510(k)

The purpose of this 510(k) is to modify the Jazz Band component of the JAZZ Systems. Minor changes are being made to the ultrasonic welding of the braid and the design of the metal buckle used to tighten the braid.

### Performance Data

These changes were assessed per ISO 10993 and static tensile testing to show equivalent biocompatibility and mechanical performance to the predicate.

## Conclusions

The modified JAZZ Band is as safe and effective as the predicate JAZZ Braid. The JAZZ Band has the same intended uses and indications, as well as similar technological characteristics and principles of operation as its predicate device. In addition, the minor technological differences between the JAZZ Band and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the modified JAZZ

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Band is as safe and effective as the predicate JAZZ Braid. Thus, the JAZZ Band is substantially equivalent.