(53 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is a temporary implant system used to correct spinal deformity and facilitate spinal fusion, which are therapeutic actions.
No
The ST360° Spinal Fixation System is described as a "temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion." It is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "temporary implant system" consisting of "screws connected to rods" manufactured from "titanium alloy". This clearly indicates a physical hardware 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 describes a surgical implant system for spinal fixation. This involves physically stabilizing the spine during fusion, not performing tests on biological samples outside the body.
- Device Description: The description details a system of screws, rods, and connectors made of titanium alloy, designed to be implanted in the spine. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the ST360° Spinal Fixation System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (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, deformities or curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to turnors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.
Product codes
NKB, MNH, MNI, KWP
Device Description
The ST360°® Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. Iumbar and sacral areas of the spine. Implants of this system consist of screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, rods in varving lengths, and fixed and adjustable transverse connectors. The implants in this system are manufactured from titanium alloy (Ti-6AI-4V ELI), conforming to ASTM F136.
This system's screws, rods, and connectors can be rigidly locked into a wide range of configurations, thereby allowing each construct to be formed to the needs of an individual patient. The ST360° Spinal Fixation System is intended to be used with bone graft which is required to provide additional spinal support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, sacral areas of the spine, sacral iliac attachment
Indicated Patient Age Range
Pedicle screw fixation is limited to skeletally mature patients.
Intended User / Care Setting
Not Found
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
The performance testing included components of the subject ST360° Spinal Fixation System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the subject S7360° Spinal Fixation System to be substantially equivalent to its predicate device, ST360° Spinal Fixation System.
- Bench testing (Static Axial Compression (Bending), Static Torsion, and Axial . Compression (Bending) Fatique per ASTM F1717-12; and Static Axial Gripping Capacity. Static Torsion Gripping Capacity, Static Flexion-Extension Gripping Capacity, Static Torsion Gripping Capacity, Static Transverse Moment Gripping Capacity, and Static Axial Torsional Capacity per ASTM F1798-97 (Reapproved 2008)) for implants, screws, rods, and connection component, confirmed the product performance of the subject ST360° Spinal Fixation System is suitable for its intended use.
- . Cadaver lab testing of the subject ST360° Spinal Fixation System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
- . Biocompatibility testing ensured the subject ST360° Spinal Fixation System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- . Sterilization and Dry Time testing ensured the subject S7360° Spinal Fixation System steam sterilization, and dry time requirements and instructions are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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510(k) SUMMARY
ST360°® Spinal Fixation System
Date of Summary Preparation:
Submitter:
Establishment Registration Number:
Company Contact:
Secondary Contact:
Trade Name:
Device Names:
Device Classifications:
Product Codes:
Regulation Numbers:
Regulation Description:
October 24, 2013
Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439
2184052
Michelle Lenz Regulatory Affairs Specialist Email: Michelle.Lenz@Zimmer.com Office 952.830.6243 Fax 952.837.6843
Jonathan Gilbert Director of Regulatory Affairs Email: Jonathan. Gilbert@Zimmer.com Office: 952.830.6385 Fax: 952,837.6985
ST360°® Spinal Fixation System
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Appliance Fixation, Spinal Interlaminal/Spinal interlaminal fixation Orthosis
Class III (Class II under 21 CFR 888.3050)
NKB, MNH, MNI, KWP
21 CFR § 888.3070 21 CFR § 888.3050
Pedicle screw spinal system
Predicate Devices:
The modified S7360'® Spinal Fixation System is substantially equivalent to the legally marketed predicate device, ST360°® Spinal Fixation System cleared in K022374, K041925 and K072183.
1
General Device Description:
The ST360°® Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. Iumbar and sacral areas of the spine. Implants of this system consist of screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, rods in varving lengths, and fixed and adjustable transverse connectors. The implants in this system are manufactured from titanium alloy (Ti-6AI-4V ELI), conforming to ASTM F136.
This system's screws, rods, and connectors can be rigidly locked into a wide range of configurations, thereby allowing each construct to be formed to the needs of an individual patient. The ST360° Spinal Fixation System is intended to be used with bone graft which is required to provide additional spinal support.
Indications for Use:
The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (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, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scollosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.
Summary of Technological Characteristics:
Implant Design: Implants of the ST360° Spinal Fixation System include polyaxial self-tapping screws of various diameters and lengths; hex end, straight, curved, and top-loading rods of various diameters and lengths, and transverse connectors in both solid and adjustable designs.
Implant Placement: Implants of the ST360° Spinal Fixation System are designed for posterior use in the thoracic, lumbar and sacral areas of the spine.
Materials - Implants and Instruments: Implants of the ST360° Spinal Fixation System are made from titanium alloy (Ti-6Al-4V ELI). The associated reusable patient-contacting instruments are manufactured from stainless steel that meets the requirements of ASTM A564 / A564M - 10: Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
Sterility - Implants and Instruments: ST360°® Spinal Fixation System implants are provided to the end user non-sterile in a poly bag and protective outer box. The associated instruments and perforated instrument cases for use with the ST360°® Spinal Fixation System implants are also supplied non-sterile. All implants and instruments must be sterilized by the healthcare facility prior to use.
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Summary of Performance Testing:
The ST360° Spinal Fixation System is substantially equivalent to the predicate devices in design, materials, function and intended use.
The performance testing included components of the subject ST360° Spinal Fixation System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the subject S7360° Spinal Fixation System to be substantially equivalent to its predicate device, ST360° Spinal Fixation System.
- Bench testing (Static Axial Compression (Bending), Static Torsion, and Axial . Compression (Bending) Fatique per ASTM F1717-12; and Static Axial Gripping Capacity. Static Torsion Gripping Capacity, Static Flexion-Extension Gripping Capacity, Static Torsion Gripping Capacity, Static Transverse Moment Gripping Capacity, and Static Axial Torsional Capacity per ASTM F1798-97 (Reapproved 2008)) for implants, screws, rods, and connection component, confirmed the product performance of the subject ST360° Spinal Fixation System is suitable for its intended use.
- . Cadaver lab testing of the subject ST360° Spinal Fixation System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
- . Biocompatibility testing ensured the subject ST360° Spinal Fixation System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- . Sterilization and Dry Time testing ensured the subject S7360° Spinal Fixation System steam sterilization, and dry time requirements and instructions are substantially equivalent to the predicate devices.
Substantial Equivalence:
The modified ST360°® Spinal Fixation System covered by this submission shares the same technological characteristics as the predicate device, ST360°® Spinal Fixation System (K022374. K041925, K072183). Both have the same intended use, operating principle, materials, packaging materials and processes, and substantially equivalent performance characteristics. The indications for use are identical except that references to hooks are being removed from the indications for the modified device. since hooks for this system were commercialized.
Design verification testing was performed on the modified ST360°® Spinal Fixation System in accordance with ASTM F1717-12, and ASTM F1798-97 (reapproved 2008). Design validation under simulated use conditions using a cadaver specimen was also performed. The test results confirm that the modified ST360'® Spinal Fixation System is substantially equivalent to the predicate device, the ST360°® Spinal Fixation System (K022374, K041925, K072183):
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2013
Zimmer Spine, Incorporated Ms. Michelle Lenz Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K133291
Trade/Device Name: ST360® Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, K WP Dated: October 24, 2013 Received: October 25, 2013
Dear Ms. Lenz:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Michelle Lenz
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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Zimmer'Spine - 510(k) - ST360°® Spinal Fixation System - Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name:
ST360°® Spinal Fixation System
Indications for Use:
The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (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, deformities or curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to turnors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zane W. Wyatt -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133291