← Product Code [OWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI) · K151740
# JAZZ System (K151740)
_Implanet, S.A. · OWI · Aug 27, 2015 · Orthopedic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K151740
## Device Facts
- **Applicant:** Implanet, S.A.
- **Product Code:** [OWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI.md)
- **Decision Date:** Aug 27, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3010
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic, Pediatric
## 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 spinal deformities 2. such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis; - 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-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
## Device Story
JAZZ System is a spinal posterior fixation implant; provides stable interface between spinal constructs and rods. Components secured around vertebral structures (lamina, facet, or transverse processes from T1 to L5). Used in orthopedic surgery by physicians to provide temporary stabilization as bone anchor during bony fusion or fracture repair. May be used with titanium or cobalt-chromium-molybdenum implants to secure attachments. Device functions as a mechanical bone fixation cerclage.
## Clinical Evidence
No clinical data. Bench testing only; the 510(k) submission was limited to a modification of the indications for use, for which no new performance data was required.
## Technological Characteristics
Components: polyester (polyethylene-terephthalate) braid, titanium alloy connector and screw, stainless steel malleable strip and buckle. Functions as a bone fixation cerclage for spinal posterior fixation. Mechanical device; no software or energy source.
## Regulatory 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
- Universal Clamp® Spinal Fixation System ([K142053](/device/K142053.md))
- JAZZ System ([K143759](/device/K143759.md))
## 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
August 27, 2015
Implanet. S.A. % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K151740
Trade/Device Name: JAZZ System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: June 26, 2015 Received: June 29, 2015
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 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.
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Page 2 - Ms. Janice M. Hogan
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# 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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510(k) Number (if known) K151740
### Device Name
#### JAZZ System
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 spinal deformities 2. such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. ന്
The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
| 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
# 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 Francois Magendie 33650 Martillac France
| Phone: | +33 557 995 555 |
|------------|-----------------|
| Facsimile: | +33 557 995 700 |
Contact Person: Reqis Le Couedic, Director of Quality and Requlatory Affairs: Chief Technology Officer
Date Prepared: June 26, 2015
## Name of Device
JAZZ System
### Common or Usual Name / Classification Name
21 CFR § 888.3010, Bone fixation cerclage; Product Code: OWI- bone fixation cerclage, sublaminar, Class II
#### Predicate Devices
Zimmer Spine, Inc.'s Universal Clamp® Spinal Fixation System (K142053) (Primary) Implanet S.A.'s JAZZ System (K143759) (Additional)
## ''''''''' 'bhYbXYX'UsY'#adications' 'Zor'l se
JAZZ is a temporary implant intended to be used in orthopedic surgery. The JAZZ System 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;
- /8. Spinal degenerative surgery, as an adjunct to spinal fusions.
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The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
## 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 screw; and stainless steel malleable strip and buckle.
# Performance Data
The purpose of this 510(k) was to modify the indications. No new performance data was needed to support the change in indications.
## Substantial Equivalence
The JAZZ System is as safe and effective as the predicate devices. The JAZZ System has the same intended use, technological characteristics, and principles of operation as the previous JAZZ System. The only notable change has been to the indications to make them equivalent to the Universal Clamp System. Thus, the JAZZ System is substantially equivalent.
# Conclusions
The JAZZ System is nearly identical to the previously cleared JAZZ System. The minor changes to its indications do not alter its intended use. The minor changes to the indications for use allow the JAZZ System to be marketed for indications identical of other legally marketed bone fixation cerclage devices. Thus, the JAZZ System is substantially equivalent.
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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K151740](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K151740)
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