JAZZ SYSTEM

K132287 · Hogan Lovells US LLP · OWI · Sep 25, 2013 · Orthopedic

Device Facts

• Record ID: K132287
• Device Name: JAZZ SYSTEM
• Applicant: Hogan Lovells US LLP
• Product Code: OWI · Orthopedic
• Decision Date: Sep 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The JAZZ is intended to be used as a temporary implant in orthopedic surgery, 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 spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The JAZZ may also be used in coniunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants. The JAZZ is intended to be used with the Implanet Spine System.

Device Story

JAZZ System is a spinal posterior fixation implant; provides stable interface between spinal constructs and rods. Components include polyester (polyethylene-terephthalate) braid, titanium alloy connector, and stainless steel malleable strip and buckle. Used in spinal surgery (trauma, reconstruction, degenerative) to secure vertebral structures (T1 to L5) as a bone anchor during bony fusion. Operated by surgeons in clinical settings. Functions as a mechanical stabilizer; used in conjunction with Implanet Spine System and other titanium alloy implants. Benefits patient by providing temporary stabilization to aid bone fracture repair and spinal deformity correction.

Clinical Evidence

Bench testing only. Testing included static tensile, viscoelastic characteristics, static axial compression corpectomy, and dynamic tension/compression testing. Biocompatibility confirmed per ISO-10993. Sterilization and shelf life validated per industry standards.

Technological Characteristics

Components: polyester (polyethylene-terephthalate) braid, titanium alloy connector, stainless steel malleable strip and buckle. Mechanical bone fixation cerclage. Biocompatibility per ISO-10993. No software or energy source.

Indications for Use

Indicated for patients undergoing spinal surgery requiring temporary stabilization as a bone anchor, including spinal trauma (sublaminar/facet wiring), spinal reconstruction (scoliosis, kyphosis, spondylolisthesis), and spinal degenerative surgery (adjunct to fusion).

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

• Zimmer Spine, Inc.'s Universal Clamp® Spinal Fixation System (K110348)
• Implanet S.A.'s JAZZ System (K121541)

Submission Summary (Full Text)

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#### Page 1 of 2

#### 510(k) SUMMARY

#### Implanet, S.A.'s JAZZ System

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

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

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

Date Prepared: September 25, 2013

#### Name of Device

JAZZ System

# Common or Usual Name / Classification Name

**SEP 2 5 2013**

888.3010 - Bone fixation cerclage

#### Product code

OWI

#### Predicate Devices

Zimmer Spine, Inc.'s Universal Clamp® Spinal Fixation System (K110348)

Implanet S.A.'s JAZZ System (K121541)

#### Intended Use / Indications for Use

The JAZZ is intended to be used as a temporary implant in orthopedic surgery, 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 spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ may also be used in coniunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants.

The JAZZ is intended to be used with the Implanet Spine System.

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#### Device Description

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.

# Technological Characteristics

The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle.

#### Performance Data

This 510(k) premarket notification incorporates by reference the bench testing performed in support of Implanet S.A.'s JAZZ System (K121541). All bench testing confirmed that the product met the necessary specifications and functioned as intended. Sterilization and shelf life validation testing conducted for the JAZZ System in accordance with recognized industry standards are also incorporated by reference. In addition, the biocompatibility of the device was confirmed in accordance with ISO-10993. A list of the tests performed to support substantial equivalence is provided below:

- Static Tensile Test (braid); .
- . Viscoelastic Characteristics (braid);
- Static Tensile Testing; .
- Static Axial Compression Corpectomy Construct Testing; .
- Dynamic Tension Testing: .
- Dynamic Axial Compression Corpectomy Construct Testing. .

In addition, verification/validation testing performed using the dynamic axial compression corpectory construct confirmed that the modified JAZZ System satisfied the acceptance criteria.

# Substantial Equivalence

The JAZZ System is substantially similar to the previously cleared JAZZ System (K121541), as well as the Zimmer Universal Clamp System (K110348). The JAZZ 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 JAZZ System and its predicate devices raise no new issues of safety or effectiveness. Thus, the JAZZ System is substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that form a stylized "H" shape.

Public Health Service

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

September 25, 2013

Implanet, S.A. % Ms. Janice M. Hogan Hogan and Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K 132287

> Trade/Device Name: JAZZ system Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: July 23, 2013 Received: July 23, 2013

# 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.

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Page 2 - Ms. Janice M. Hogan

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 (reporting of medical device-related 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 OFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/default.htm for the CDRF/'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/MedicalDeviccs/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith

for

Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

K132287 510(k) Number (if known):

Device Name: JAZZ System

#### 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 spinal deformities 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 allov whenever "wiring" may help secure the attachment of other implants.

The JAZZ System is intended to be used with the Implanet Spine System.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132287

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