(80 days)
Not Found
No
The document describes a spinal fixation system and navigated surgical instruments. While it mentions image guidance systems (StealthStation®) that use CT, MR, or fluoroscopy images, there is no mention of AI or ML being used for image processing, analysis, or any other function of the device or associated systems. The performance studies focus on biocompatibility and mechanical testing, not algorithmic performance.
Yes
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for multiple medical conditions, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and/or failed previous fusion. These are all therapeutic indications.
No
The device described is a spinal system (CD HORIZON® Spinal System) and navigated reusable instruments intended for surgical fixation and guidance during spinal surgery. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists various hardware components such as rods, hooks, screws, plates, staples, connecting components, and instruments. While it mentions compatibility with a computer-assisted surgery system (StealthStation®), the core device being described is a physical spinal implant system and associated surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the CD HORIZON® Spinal System and associated instruments are used during surgery to fix and stabilize the spine. They are physical implants and surgical tools used directly on the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, the CD HORIZON® Spinal System and its associated instruments fall under the category of surgical implants and instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion 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 stenosis, curvatures (i.e., scoliosis, 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® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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.
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNH, MNI, KWP, KWQ, OLO, HBE
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 subject devices include:
• Bone screws
• Rods
• Set Screws
• Extender
• Extender Cap
• Accessories, case, caddies trays, and lids which may be used to transport and sterilize the subject implants and instruments.
The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems. -
MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS For use with StealthStation® and IPC® POWEREASE™ Systems
Medtronic Navigated Reusable Screwdriver is a spine preparation instrument made of high grade stainless steel. This instrument was specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.
Medtronic Navigated Reusable Screwdriver is compatible with various Medtronic spinal implant systems. This screwdriver is also compatible with Medtronic's IPC® POWEREASET™ System when connected to the POWEREASET™ Driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model, fluoroscopy images
Anatomical Site
non-cervical spine (T1-S1), thoracic lumbar and/or sacral spine
Indicated Patient Age Range
Skeletally mature patients, pediatric patients
Intended User / Care Setting
Surgeon, clinical setting
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)
Biocompatibility: The biocompatibility evaluation for the CD HORIZON® Spinal System devices was conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April, 23, 2013. The subject CD HORIZON® Spinal System bone screws, rods, and set screws are permanent implants and will be classified as permanent , >30 day body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject bone screws are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards: ASTM F1537 – Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants; ASTM F67 - Specification for Unalloyed Titanium for Surgical Implant Applications; ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The subject rods are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards: ASTM F1537 – Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum. The subject set screws are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards: ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The CD HORIZON® Spinal System extender, Extender Cap and screwdriver are external communicating devices and are classified as limited, up to 24 hours of body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These instruments are manufactured from the same medical grade stainless steel as the predicate devices in accordance with the following ASTM standards: ASTM F899 – Standard Specification for Wrought Stainless Steel for Surgical Instruments; ASTM A564 – Standard Specification for Hot-Rolled and Cold Finished Age-Hardening Stainless Steel Bars and Shapes; ASTM A693 – Standard Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheet and Stripe; ASTM A276 – Standard Specification for Stainless Bars and Shapes. The case, caddies trays, and lids used to for shipment and sterilization of instruments are manufactured from aluminum and/or radel and/or polypropylene with the brackets securing the instruments into the case/tray made of silicone and/or nylon coated stainless steel and/or polypropylene and are not patient contacting and do not require biocompatiblity testing. Cobalt Chrome, Commercially Pure Titanium, Titanium Alloy, and medical grade stainless steel have a long history of safe and effective use in spinal surgery and biocompatibility testing is not required and not testing was conducted.
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. It was determined that subject devices do not represent a new worst case. Engineering rationales were used to demonstrate substantial equivalence.
Key results: Based on the risk analysis, test results, and additional supporting documentation provided in the pre-market notification, the subject CD HORIZON® Spinal System is substantially equivalent to the stated predicates. The MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS are substantially equivalent to the stated predicate.
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.
K142847, K091974, K113529, K132639, K102555, K141605, K140454
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 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 stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around the edge.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Becky Ronner Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
February 13, 2015
Re: K143375
Trade/Device Name: CD HORIZON® Spinal System, Medtronic Navigated Reusable Instruments Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ, OLO, HBE Dated: January 16, 2015 Received: January 20, 2015
Dear Ms. Ronner:
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
1
Page 2 - Ms. Becky Ronner
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 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)
Device Name CD HORIZON® Spinal System
Indications for Use (Describe)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion 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 stenosis, curvatures (i.e., scoliosis, 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® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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.
Type of Use (Select one or both, as applicable)
2 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)
3
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."
4
Indications for Use
510(k) Number (if known)
Device Name
Medtronic Navigated Reusable Instruments
Indications for Use (Describe)
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
Type of Use (Select one or both, as applicable)
2 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)
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."
5
510(k) SUMMARY
MEDTRONIC Sofamor Danek USA
January 2015
| Medtronic Sofamor Danek, USA Inc. | |
|---|---|
| Submitter: | 1800 Pyramid Place |
| Memphis, Tennessee 38132 | |
| Telephone: (901)396-3133 | |
| Fax: (901) 346-9738 | |
| Contact Person | Becky Ronner |
| Senior Regulatory Affairs Specialist | |
| Direct Telephone: (901)399-2757 | |
| Date Prepared | November 21, 2014 |
| Common Name | Bone Screws, Rods, Set Screws, Extenders, and Drivers |
| Device/Trade Name | 1. CD HORIZON® Spinal System |
| 2. MEDTRONIC NAVIGATED REUSABLE | |
| INSTRUMENTS | |
| For use with StealthStation® and IPC® POWEREASE™ | |
| Systems | |
| Regulatory Class, | |
| Regulation Number, | |
| Regulation Name, and | |
| Device Product Code | 1. CD HORIZON® Spinal System |
| • Class III | |
| • 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis; KWP | |
| • 21 CFR 888. 3060 Spinal Intervertebral Body Fixation Orthosis; KWQ | |
| • 21 CFR 888.3070 Pedicle Screw System; MNH, MNI, NKB, OSH | |
| 2. MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS | |
| For use with StealthStation® and IPC® POWEREASE™ Systems | |
| • Class II | |
| • 21 CFR 882.4560 Stereoitaxic Instruments; OLO | |
| • 21 CFR 882.4310 Drills, Burs, Trephines & Accessories (Simple, Powered); HBE | |
| Predicate Devices | 1. CD HORIZON® Spinal System |
| • K142847 CD HORIZON® Spinal System (S.E. | |
| 10/27/2014) Primary Predicate | |
| • | K091974 CD HORIZON® Spinal System (S.E 9/2/2009) |
| • | K113529 CD HORIZON® Spinal System (S.E 2/9/2011) |
| • | K132639 CD HORIZON® Spinal System (S.E |
| 11/25/2013) | |
| • | K102555 CD HORIZON® Spinal System (S.E |
| 11/17/2010) | |
| • | K141605 CD HORIZON® Spinal System (S.E 7/14/2014) |
| 2. | MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS |
| For use with StealthStation® and IPC® POWEREASE™ | |
| Systems | |
| • | K140454 Navigated Instruments (S.E 5/22/2014) |
| The predicates have not been subject to a design related | |
| recall. | |
| 1. 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 | |
| subject devices include: | |
| • | Bone screws |
| • | Rods |
| • | Set Screws |
| • | Extender |
| • | Extender Cap |
| Description of Device | • Accessories, case, caddies trays, and lids which may be |
| used to transport and sterilize the subject implants and | |
| instruments. | |
| The subject CD HORIZON® Spinal System device will be | |
| available in similar sizes as the predicate systems. | |
| 2. MEDTRONIC NAVIGATED REUSABLE | |
| INSTRUMENTS For use with StealthStation® and IPC® | |
| POWEREASE™ Systems | |
| Medtronic Navigated Reusable Screwdriver is a spine | |
| preparation instrument made of high grade stainless steel. | |
| This instrument was specifically designed for use in | |
| procedures where the use of stereotactic surgery may be | |
| appropriate. Placing Medtronic single-use sterile spheres | |
| on each of the NavLock™ Tracker passive stems allows a | |
| Medtronic computer-assisted surgery system such as the | |
| StealthStation® Image Guidance System to track the | |
| instruments in the surgical field. |
Medtronic Navigated Reusable Screwdriver is compatible
with various Medtronic spinal implant systems. This
screwdriver is also compatible with Medtronic's IPC®
POWEREASET™ System when connected to the
POWEREASET™ Driver. |
| Indications for Use | 1. CD HORIZON® Spinal System
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 stenosis, curvatures (i.e., scoliosis, kyphosis, 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 progressive spinal deformities (i.e., scoliosis, |
6
7
8
| kyphosis, or lordosis) including idiopathic scoliosis, | ||
|---|---|---|
| neuromuscular scoliosis, and congenital scoliosis. | ||
| Additionally, the CD HORIZON® Spinal System is | ||
| intended to treat pediatric patients diagnosed with the | ||
| following conditions: spondylolisthesis/spondylolysis, | ||
| fracture caused by tumor and/or trauma, pseudarthrosis, | ||
| and/or failed previous fusion. 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. | ||
| 2. | MEDTRONIC NAVIGATED REUSABLE | |
| INSTRUMENTS For use with StealthStation® and IPC® | ||
| POWEREASET™ Systems | ||
| Medtronic Navigated Reusable Instruments are intended to | ||
| be used during the preparation and placement of Medtronic | ||
| screws during spinal surgery to assist the surgeon in | ||
| precisely locating anatomical structures in either open, or | ||
| minimally invasive, procedures. Medtronic Navigated | ||
| Reusable Instruments are specifically designed for use with | ||
| the StealthStation® System, which is indicated for any | ||
| medical condition in which the use of stereotactic surgery | ||
| may be appropriate, and where reference to a rigid | ||
| anatomical structure, such as a skull, a long bone, or | ||
| vertebra, can be identified relative to a CT or MR-based |
9
| model, fluoroscopy images, or digitized landmarks of the | |
|---|---|
| anatomy. Medtronic Navigated Reusable Instruments are | |
| also compatible with the IPC® POWEREASET™ System. | |
| 1. CD HORIZON® Spinal System | |
| Comparison of | |
| Technological | |
| Characteristics with the | |
| Predicate Devices: | The CD HORIZON® Spinal System has the same |
| fundamental technology, cobalt chrome, titanium and stainless | |
| steel material as the predicate devices. The predicate and | |
| subject devices are intended to help provide immobilization | |
| and stabilization of spinal segments as an adjunct to fusion of | |
| the thoracic lumbar and/or sacral spine. | |
| K142847 CD HORIZON® Spinal System (S.E. | |
| 10/27/2014) (Primary Predicate) K091974 CD HORIZON® Spinal System (S.E 9/2/2009) K113529 CD HORIZON® Spinal System (S.E 2/9/2011) K132639 CD HORIZON® Spinal System (S.E | |
| 11/25/2013) K102555 CD HORIZON® Spinal System (S.E | |
| 11/17/2010) K141605 CD HORIZON® Spinal System (S.E 7/14/2014) 2. MEDTRONIC NAVIGATED REUSABLE | |
| INSTRUMENTS For use with StealthStation® and IPC® | |
| POWEREASET™ Systems |
The subject Medtronic Navigated Reusable Instrument for use
with StealthStation® and IPC® POWEREASET™ Systems
has the same fundamental technology and stainless steel
material as the predicate devices. The predicate and subject
devices are intended to be used during the preparation and
placement of Medtronic screws during spinal surgery to assist
the surgeon in precisely locating anatomical structures in
either open, or minimally invasive, procedures. Medtronic
Navigated Reusable Instruments are specifically designed for
use with the StealthStation® System, which is indicated for
any medical condition in which the use of stereotactic surgery
may be appropriate, and where reference to a rigid anatomical
structure, such as a skull, a long bone, or vertebra, can be
identified relative to a CT or MR-based model, fluoroscopy
images, or digitized landmarks of the anatomy. Medtronic |
| | Navigated Reusable Instruments are also compatible with the |
10
| Performance Data: | IPC® POWEREASET™ System.
K140454 Navigated CD HORIZON® Instruments (S.E
5/22/2014)
The following performance data were provided in support of
substantial equivalence. |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility
The biocompatibility evaluation for the CD HORIZON®
Spinal System devices was conducted in accordance with
FDA's Draft Guidance for Industry and FDA Staff "Use of
International Standard ISO-10993, Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing" issued April,
23, 2013. |
| | The subject CD HORIZON® Spinal System bone screws,
rods, and set screws are permanent implants and will be
classified as permanent , >30 day body contact according to
with FDA's Draft Guidance for Industry and FDA Staff "Use
of International Standard ISO-10993, Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing". The subject
bone screws are manufactured from identical materials as the
predicate devices, in accordance with the following ASTM
standards: |
| | • ASTM F1537 – Standard Specification for
Wrought Cobalt-28-Chromium-6-Molybdenum
Alloys for Surgical Implants |
| | • ASTM F67 - Specification for Unalloyed Titanium
for Surgical Implant Applications |
| | • ASTM F136 - Standard Specification for Wrought
Titanium-6 Aluminum-4 Vanadium ELI (Extra
Low Interstitial) Alloy for Surgical Implant
Applications |
| | The subject rods are manufactured from identical materials as
the predicate devices, in accordance with the following
ASTM standards: |
| | • ASTM F1537 – Standard Specification for
Wrought Cobalt-28-Chromium-6-Molybdenum |
11
| Alloys for Surgical Implants |
|---|
| The subject set screws are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards: |
| ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications |
| The CD HORIZON® Spinal System extender, Extender Cap and screwdriver are external communicating devices and are classified as limited, up to 24 hours of body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These instruments are manufactured from the same medical grade stainless steel as the predicate devices in accordance with the following ASTM standards: |
| ASTM F899 – Standard Specification for Wrought Stainless Steel for Surgical Instruments ASTM A564 – Standard Specification for Hot-Rolled and Cold Finished Age-Hardening Stainless Steel Bars and Shapes ASTM A693 – Standard Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheet and Stripe ASTM A276 – Standard Specification for Stainless Bars and Shapes |
| The case, caddies trays, and lids used to for shipment and sterilization of instruments are manufactured from aluminum and/or radel and/or polypropylene with the brackets securing the instruments into the case/tray made of silicone and/or nylon coated stainless steel and/or polypropylene and are not patient contacting and do not require biocompatiblity testing. |
12
| | Cobalt Chrome, Commercially Pure Titanium, Titanium
Alloy, and medical grade stainless steel have a long history of
safe and effective use in spinal surgery and biocompatibility
testing is not required and not testing was conducted. |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. It was determined that subject devices do
not represent a new worst case. Engineering rationales were
used to demonstrate substantial equivalence. |
| | Based on the risk analysis, test results, and additional
supporting documentation provided in the pre-market
notification, the subject CD HORIZON® Spinal System
is substantially equivalent to the following predicates: |
| Conclusion: | • K142847, K091974, K113529, K132639,
K102555, K141605 |
| | |
| | The MEDTRONIC NAVIGATED REUSABLE
INSTRUMENTS are substantially equivalent to
the following predicate: |
| | |
| | • K140454 |