(110 days)
No
The summary describes a system of physical implants (hooks, rods, connectors) and manual surgical instruments for spinal fixation. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on mechanical strength testing.
No.
The device is an orthopedic implant intended to provide stabilization as an adjunct to fusion or during the repair of bone fractures, rather than to treat a disease or health condition directly.
No
Explanation: The Jazz Claw System is described as a system of hooks and rods intended for immobilization and posterior fixation of spinal segments as an adjunct to fusion and for temporary stabilization during bone fusion and repair of bone fractures. It is a surgical implant system, not a device used to diagnose medical conditions.
No
The device description explicitly states it consists of physical components: hooks, rods, and connectors, which are temporary implants used in orthopedic surgery. It also mentions manual surgical instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Jazz Claw System is for providing immobilization of spinal segments as an adjunct to fusion and for posterior fixation for various spinal conditions. It is a surgical implant used directly on the patient's body.
- Device Description: The device is described as hooks, rods, and connectors, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Jazz Claw System is an in vivo device (used inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector 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;
-
- Spinal reconstructive surqery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ CLAW connector may also be used in coniunction with other medical implants made of titanium allov or Cobalt-chromium-molybdenum alloy whenever "wiring" mav help secure the attachment of other implants.
The Jazz Claw System (hooks and rods) is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior 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 (fracture or dislocation);
- spinal stenosis:
- spinal deformities (scoliosis, kyphosis and/or lordlosis)
- tumor;
- pseudarthrosis; and
- revision of a failed fusion attempt.
The Jazz Claw System (hooks and rods) is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNI, MNH, KWP, OWI
Device Description
The JAZZ CLAW System consists of the JAZZ CLAW hook and JAZZ CLAW rod.
The JAZZ CLAW connector and the cleared JAZZ braid are also separate components, as well as manual surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments of the thoracic, lumbar and/or sacral spine.
Indicated Patient Age Range
Skeletally mature patients. Adolescent idiopathic scoliosis (for JAZZ CLAW System (hooks and rods)).
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)
Performance Data:
The strength of the overall construct (JAZZ CLAW connector used with hooks and rods) was assessed per ASTM F1717 dynamic axial compression testing and found to be equivalent to the predicate JAZZ system (K151740) and Implanet Spinal System (K143731). In addition. enqineering rationales were performed to support device performance of the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods).
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.
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.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
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.
(b)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2016
Implanet, S.A. % Ms. Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K160226
Trade/Device Name: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP, OWI Dated: April 11, 2016 Received: April 11, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 (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" (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/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
Indications for Use
510(k) Number (if known)
K160226
Device Name
JAZZ CLAW System (hooks and rods)
Indications for Use (Describe)
The Jazz Claw System (hooks and rods) is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic. Jumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior 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 (fracture or dislocation);
- spinal stenosis; ●
- spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
- tumor:
- . pseudarthrosis; and
- revision of a failed fusion attempt. ●
The Jazz Claw System (hooks and rods) is indicated as an adjunct to freat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.
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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"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.
FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
3
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
JAZZ CLAW connector
Indications for Use (Describe)
The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector 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:
- 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 CLAW connector 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
区 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 Drug 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.
FORM FDA 3881 (8/14)
Page 1 of 4
4
510(k) SUMMARY
Implanet, S.A.'s JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
Submitter'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: Regis Le Couedic, Director of Quality and Regulatory Affairs; Chief Technology Officer
Date Prepared: May 17, 2016
Name of Device
-
- JAZZ CLAW connector
-
- JAZZ CLAW System (hooks and rods)
Common or Usual Name
-
- Bone fixation cerclage
-
- Pedicle screw system
Classification Name
-
- 21 CFR § 888.3010, Bone fixation cerclage; Product Code: OWI
-
- 21 CFR § 888.3070, Pedicle screw spinal system; Product Codes: NKB, OSH, MNI, MNH; 21 CFR § 888.3050, Spinal interlaminal fixation orthosis ; Product Code: KWP
Predicate and Reference Devices
-
- Implanet S.A. JAZZ System (K151740) (primary predicate for JAZZ CLAW connector)
Intended Use / Indications for Use
-
- The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector 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.
5
The indications for use include the following applications:
-
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
- Spinal reconstructive surqery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ CLAW connector may also be used in coniunction with other medical implants made of titanium allov or Cobalt-chromium-molybdenum alloy whenever "wiring" mav help secure the attachment of other implants.
-
- The Jazz Claw System (hooks and rods) is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior 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 (fracture or dislocation); ●
- spinal stenosis: ●
- spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
- tumor; ●
- pseudarthrosis; and ●
- o revision of a failed fusion attempt.
The Jazz Claw System (hooks and rods) is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.
Device Description / Technological Characteristics
The JAZZ CLAW System consists of the JAZZ CLAW hook and JAZZ CLAW rod.
The JAZZ CLAW connector and the cleared JAZZ braid are also separate components, as well as manual surgical instruments.
Technological Comparison
The technological differences with the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods) in comparison to the predicates for each device are minor. Both the JAZZ CLAW connector and the JAZZ System consist of a connector that attaches to the rods of a pedicle screw system (i.e., the JAZZ CLAW System (hooks and rods) and contains a braid to "wire" the surrounding bony structure.
The JAZZ CLAW System (hooks and rods) also contains an additional component, a laminar hook. This hook is similar to other hooks cleared in pedicle screw systems, such as the Implanet Spine System (K143731), and provides an additional attachment point to the spine. The addition of the hook does not raise different safety or effectiveness questions as it is a component typically included in pedicle screw systems to which the JAZZ CLAW connector
6
attaches. Thus, the modification to include a hook simply supplies the surgeon with an alternate method to add a laminar hook to the previously cleared Implanet Spine System.
Both the JAZZ CLAW connector and the cleared JAZZ System use established connection mechanisms. Specifically, both the JAZZ System and the JAZZ CLAW connector contain an internal screw used to tighten the device onto a rod. For the cleared JAZZ system, the rod is part of a separately cleared pedicle screw system while the JAZZ CLAW is connected to the JAZZ CLAW System (hooks and rods) via a rod dedicated for the hook. The JAZZ CLAW System also contains a set screw locking mechanism, identical to the locking mechanism cleared with the ISS pedicle screw system (K143731). The hook also attaches to its dedicated rod via the same set screw mechanism.
Performance Data
The strength of the overall construct (JAZZ CLAW connector used with hooks and rods) was assessed per ASTM F1717 dynamic axial compression testing and found to be equivalent to the predicate JAZZ system (K151740) and Implanet Spinal System (K143731). In addition. enqineering rationales were performed to support device performance of the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods).
Substantial Equivalence
The JAZZ CLAW connector is substantially equivalent to the cleared JAZZ System. The JAZZ CLAW System (hooks and rods) are substantially equivalent to the cleared Implanet Spinal System and Synthes Cervifix System. The subject devices have the same intended uses and indications, and similar technological characteristics, and principles of operation as their associated predicate devices. The minor technological differences between the subject devices and the predicate devices raise no new issues of safety or effectiveness.