(260 days)
No
The summary describes a mechanical pedicle screw system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical testing.
Yes.
The device is described as "intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities and deformities of the thoracic, lumbar, and sacral spine," which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
This device is a pedicle screw system intended for immobilization and stabilization of spinal segments, acting as an adjunct to fusion for treating various spinal instabilities and deformities. It is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description explicitly states that the device components are manufactured from metal alloys (Ti6Al4V and Cobalt-Chromium) and are surgically implanted. This indicates a physical, hardware-based medical device, not a software-only device.
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 the device is for "immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used to treat structural problems in the spine.
- Device Description: The description details the materials and components of a pedicle screw system, 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, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are 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 and deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; and failed previous fusion (pseudarthrosis). In addition, the C-Zero Pedicle Screw and Freedom Pedicle Systems are intended for skeletally mature patients in the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.
Product codes
NKB
Device Description
All of the Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems' components (except for CoCr longitudinal rods) are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136. The subject systems' CoCr longitudinal rods are manufactured from wrought Cobal-Chromium as per ASTM-F1537.
The Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems are used to provide immobilization and stabilization of spinal segments in the treatment of acute and chronic instabilities or deformities of the lumbar, thoracic and sacral spine. These pedicel rod and screw systems surgically implanted from a posterior approach. The device subject to this file include polyaxial pedicle screws, rods, connectors and hooks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are adequate for anticipated in-vivo use. The following nonclinical testings were carried out on the worst case sizes of the subject pedicle screws:
- Static and dynamic compression bending testing
- Static torsion testing
- Static Flexion-Extension Moment Test
- Axial Gripping Test
- Axial Torsional Test
- Axial Gripping Test of connector components
- Torsional Gripping Test of connector components
- Screw insertion testing
- Screw pull-out testing
- Screw torque to failure testing
- Freedom Dissociation Test at the screw-tulip interface
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081252, K041449, K023644, K052398, K150184
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 7, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, 2066 AU NSW
Re: K180754
Trade/Device Name: C-Zero Pedicle Screw System, Freedom Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB Dated: October 31, 2018 Received: November 5, 2018
Dear Declan Brazil:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S for MNM
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) K180754
Device Name
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
Indications for Use (Describe)
The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are 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 and deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; and failed previous fusion (pseudarthrosis). In addition, the C-Zero Pedicle Screw and Freedom Pedicle Systems are intended for skeletally mature patients in the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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2 510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name: | C-Zero Pedicle Screw System
Freedom Pedicle Screw System |
| Common Name: | Pedicle screw spinal system |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia
Phone: +61 (2) 9428 5181
Fax: +61 (2) 8456 6065 |
| Date Prepared: | October 31st, 2018 |
| Classification: | Class II per 21 CFR 888.3070: Thoracolumbosacral Pedicle Screw
System (NKB) |
| Predicate Devices: | Primary Predicate
• DePuy Synthes's EXPEDIUM 4.5mm Spine System (K081252)
Additional Predicate
• INTERPORE CROSS International Synergy Spinal Systems (K041449)
• Spinal Concepts' InCompass Spinal Fixation System (K023644)
• K2M Mesa Spinal System (K052398)
• Back to Basic Dymaxeon Spine System (K150184)
Reference Predicate
• Signature Orthopaedics NOOSA ALIF Plate (K163625)
• Signature Orthopaedics CoCr Femoral Head (K121297) |
Device Description:
All of the Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems' components (except for CoCr longitudinal rods) are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136. The subject systems' CoCr longitudinal rods are manufactured from wrought Cobal-Chromium as per ASTM-F1537.
The Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems are used to
4
provide immobilization and stabilization of spinal segments in the treatment of acute and chronic instabilities or deformities of the lumbar, thoracic and sacral spine. These pedicel rod and screw systems surgically implanted from a posterior approach. The device subject to this file include polyaxial pedicle screws, rods, connectors and hooks.
Indications for Use:
The Signature Orthopaedic C-Zero Pedicle Screw and Freedom Pedicle Screw Systems are 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 and deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; and failed previous fusion (pseudarthrosis). In addition, the C-Zero Pedicle Screw and Freedom Pedicle Systems are intended for skeletally mature patients in the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.
Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are adequate for anticipated in-vivo use. The following nonclinical testings were carried out on the worst case sizes of the subject pedicle screws:
- Static and dynamic compression bending testing
- . Static torsion testing
- Static Flexion-Extension Moment Test
- Axial Gripping Test
- . Axial Torsional Test
- . Axial Gripping Test of connector components
- . Torsional Gripping Test of connector components
- . Screw insertion testing
- Screw pull-out testing
- Screw torque to failure testing
- . Freedom Dissociation Test at the screw-tulip interface
Testing Standards:
- ASTM-F1717 Standard Test Methods for Spinal Implant Construct in a ● Vertebrectomy Model
- ASTM-F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM-F543 Standard Specification and Test Method for Metallic Medical Bone Screw
Substantial Equivalence:
The substantial equivalence of the subject devices to the predicate devices above is based
5
upon the similarity of intended use, design (fundamental scientific technology), materials and performance.
Comparison of technological characteristics
The Signature Orthopaedics C-Zero and Freedom Pedicle Screw Systems were biomechanically tested and compared to other predicate systems currently on the market. The design features and sizing of the components were also compared to the predicate devices and found to be substantially the same as these systems. The substantial equivalency between the subject and predicate devices were established based on the following similarities:
- The same indication for use .
- . The same range of intended surgery sites
- Manufactured from similar materials ●
- Similar in most of design features
- Similar Surgical Techniques
- Similar size range ●
The following technological differences exist between the subject and predicate devices:
- Some of design features detail .
- . Cap Screw diameters
- . Varieties of tulip offered
Conclusion
Based upon the predicate comparison, the intended use, similar technological characteristics and the results of the various mechanical testing, the proposed devices are substantially equivalent to the predicate devices.