(62 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of AI or ML capabilities.
Yes
The device is described as a "temporary implant to be used in orthopedic surgery" intended to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures," clearly indicating a therapeutic purpose.
No
The device is a temporary implant used for stabilization during orthopedic surgery, not for diagnosing conditions. Its function is to provide physical support, not to detect or analyze medical conditions.
No
The device description explicitly lists hardware components such as polyester braid, titanium alloy connector and screw, and stainless steel malleable strip and buckle.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that JAZZ is a "temporary implant to be used in orthopedic surgery" for "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a surgical device used in vivo (within the body) for structural support and stabilization.
- Device Description: The description details components like a polyester braid, titanium alloy connector and screw, and stainless steel malleable strip and buckle. These are all physical components designed for implantation and mechanical function within the body.
- Anatomical Site: The device is used on "Spinal structures such as the lamina, facet, or transverse processes from T1 to L5," which are internal anatomical structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used directly on the body for structural support.
N/A
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:
- 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.
Product codes (comma separated list FDA assigned to the subject device)
OWI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new performance data was needed to support the change in indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zimmer Spine, Inc.’s Universal Clamp® Spinal Fixation System (K142053), Implanet S.A.’s JAZZ System (K143759)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
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.(b)
Classification. Class II.
0
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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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:
-
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
- 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.
4
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.