(127 days)
No
The 510(k) summary describes a spinal implant system consisting of mechanical components and materials. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests.
Yes
The device is described as an "adjunct to fusion" for various spinal conditions, indicating its role in treatment and healing.
No
Explanation: The device is a spinal implant system intended for posterior non-cervical fixation as an adjunct to fusion for various spinal conditions. Its described purpose is to provide immobilization and support as part of a surgical fusion procedure, not to diagnose medical conditions.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, plates, and connecting components made from various medical-grade materials. It is a spinal implant system, not a software-only device.
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 as an adjunct to fusion. This is a therapeutic device used in vivo (within the body) to treat structural issues in the spine.
- Device Description: The device is described as a system of rods, hooks, screws, plates, and connecting components made from various medical-grade materials. These are physical implants.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The CD HORIZON® Spinal System with or without SEXTANT® intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatic indications noted below.
When used for posterior non-cervical pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/ or trauma. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the noncervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNH, MNI, KWP, KWQ
Device Description
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt chromium molybdenum alloy, or medical grade PEEK OPTIMA-LTI. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.
The purpose of this 510(k) is to add additional non-sterile rods to the CD HORIZON® Spinal System. The type of rods includes a series of tapered and straight rods. The subject rods are manufactured out of medical grade cobalt-chromium-molybdenum alloy.
The subject rods along with other components such as metal screws, hooks and other connecting components are intended to help provide immobilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical; non-cervical spine (TI-S1); thoracic, lumbar, and/or sacral spine
Indicated Patient Age Range
skeletally mature patients; pediatic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical Testing
In accordance with, Guidance for Industry and FDA Staff - Spinal System 510(k)'s, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing was completed in accordance with ASTM F1798 - "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The tests completed were:
- Axial Grip Testing
- Axial Torsion Testing
- Flexion Extension Static Testing
- Flexion Extension Fatigue Testing
Construct compression bending fatigue testing was also completed in accordance with ASTM F 1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
The subject devices met the pre-determined acceptance criteria for all tests.
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.
K132111, K043488, K113174, K121680
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 the department's name encircling a stylized emblem. The emblem features three human profiles facing right, layered to create a sense of depth and unity. The profiles are rendered in a simple, elegant style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2014
Medtronic Sofamor Danek USA, Incorporated Ms. Lila Joe Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K141604
Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: September 26, 2014 Received: September 29, 2014
Dear Ms. Joe:
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
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" (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.
Ronald鸭剑ean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141604
Device Name CD HORIZON® Spinal System
Indications for Use (Describe)
The CD HORIZON® Spinal System with or without SEXTANT® intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatic indications noted below.
When used for posterior non-cervical pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/ or trauma. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the noncervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Expiration Date: January 31, 2017 See PRA Statement on last page.
Form Approved: OMB No. 0910-0120
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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CD HORIZON® Spinal System 510(k) Summarv September 26, 2014
| I. | Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133 |
|------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Lila Joe
Principal Regulatory Affairs Specialist |
| II. | Proprietary Trade Name: | CD HORIZON® Spinal System |
| III. | Classification Name: | Pedicle Screw Spinal System, Spinal Intervertebral Body Fixation
Orthosis, and Spinal Interlaminal Fixation Orthosis (21 CFR
888.3070, 888.3060 and 888.3050) |
| IV. | Classification: | Class III |
| V. | Product Codes: | NKB. OSH. MNH. MNI. KWO. KWP |
VI. Product Description
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt chromium molybdenum alloy, or medical grade PEEK OPTIMA-LTI. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.
The purpose of this 510(k) is to add additional non-sterile rods to the CD HORIZON® Spinal System. The type of rods includes a series of tapered and straight rods. The subject rods are manufactured out of medical grade cobalt-chromium-molybdenum alloy.
The subject rods along with other components such as metal screws, hooks and other connecting components are intended to help provide immobilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine.
VII. Indications
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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 (i.e., fracture or dislocation); spinal
5
stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondvlolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
VIII. Summary of the Technological Characteristics
The subject CD HORIZON® Spinal System rods have identical indications, intended use, fundamental scientific technology, materials, and similar design features as the CD HORIZON® Spinal System predicates previously cleared by FDA in K043488 (S.E. 03/21/2005), K113174 (S.E. 11/21/2011), K121680 (S.E. 07/05/2012), and primary predicate K132111 (S.E. 08/06/2013). Like the predicate CD HORIZON® Spinal System rods, the subject rods have diameters ranging from 4.75mm to 6.30mm and lengths of 500mm and 600mm.
IX. Identification of Legally Marketed Devices
The subject CD HORIZON® Spinal System indications, intended use, fundamental scientific technology, design features, sterilization, and materials are similar to Medtronic's CD HORIZON® Spinal System. These predicates include CD HORIZON® Spinal System K042025 (S.E. 08/25/2004), K043488 (S.E. 03/21/2005), K091974 (S.E. 09/02/2009), K113174 (S.E. 11/21/2011), K121680 (S.E. 07/05/2012), and K132111 (primary predicate, S.E. 08/06/2013)
6
X. Discussion of the Non-Clinical Testing
Mechanical Testing
In accordance with, Guidance for Industry and FDA Staff - Spinal System 510(k)'s, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing was completed in accordance with ASTM F1798 - "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The tests completed were:
- -Axial Grip Testing
- Axial Torsion Testing -
- -Flexion Extension Static Testing
- Flexion Extension Fatigue Testing -
Construct compression bending fatigue testing was also completed in accordance with ASTM F 1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
The subject devices met the pre-determined acceptance criteria for all tests.
Conclusions Drawn from the Non-Clinical Tests XI.
No new risks have been introduced to the CD HORIZON® Spinal System by the addition of the subject rods, and the subject rods do not create a new worst case for the overall CD HORIZON® Spinal System. Therefore, Medtronic believes the subject CD HORIZON® Spinal System, including the subject rods, to be substantially equivalent to legally marketed predicate devices, including the predicate CD HORIZON® Spinal System.