CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · Medtronic Sofamor Danek USA, Inc. · NKB · Feb 13, 2015 · Orthopedic
Device Facts
Record ID
K143375
Device Name
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
Applicant
Medtronic Sofamor Danek USA, Inc.
Product Code
NKB · Orthopedic
Decision Date
Feb 13, 2015
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
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, 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.
Device Story
System comprises spinal implants (rods, hooks, screws, plates, set screws) and navigated reusable instruments (screwdrivers). Implants provide rigid immobilization/stabilization of spinal segments as adjunct to fusion. Navigated instruments feature NavLock™ passive stems with single-use sterile spheres for tracking by StealthStation® image guidance system; compatible with IPC® POWEREASE™ system. Used in OR by surgeons for open or minimally invasive spinal procedures. Navigation allows precise anatomical localization relative to CT/MR models or fluoroscopy. Benefits include improved surgical accuracy and spinal stabilization.
Clinical Evidence
Bench testing only. Biocompatibility evaluation conducted per ISO 10993. Mechanical testing performed to demonstrate substantial equivalence; engineering rationales provided. No clinical data included.
Technological Characteristics
Materials: Cobalt-28-Chromium-6-Molybdenum (ASTM F1537), Unalloyed Titanium (ASTM F67), Ti-6Al-4V ELI (ASTM F136), Stainless Steel (ASTM F899, A564, A693, A276). Instruments: Stainless steel. Cases: Aluminum, Radel, polypropylene, silicone, nylon-coated stainless steel. Navigation: Passive tracking via NavLock™ stems with sterile spheres. Connectivity: Compatible with StealthStation® and IPC® POWEREASE™ systems.
Indications for Use
Indicated for skeletally mature and pediatric patients requiring posterior non-cervical spinal fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and failed previous fusion. Navigated instruments indicated for use in spinal surgery to assist surgeons in locating anatomical structures during screw preparation and placement.
Regulatory Classification
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.
Special Controls
*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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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
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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
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### Indications for Use
510(k) Number (if known)
K143375
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)
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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:
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### Indications for Use
510(k) Number (if known)
K143375
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."
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### 510(k) SUMMARY
# MEDTRONIC Sofamor Danek USA
# January 2015
| | Medtronic Sofamor Danek, USA Inc. |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | 1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: (901)396-3133<br>Fax: (901) 346-9738 |
| Contact Person | Becky Ronner<br>Senior Regulatory Affairs Specialist<br>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<br>INSTRUMENTS<br>For use with StealthStation® and IPC® POWEREASE™<br>Systems |
| Regulatory Class,<br>Regulation Number,<br>Regulation Name, and<br>Device Product Code | 1. CD HORIZON® Spinal System<br>• Class III<br>• 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis; KWP<br>• 21 CFR 888. 3060 Spinal Intervertebral Body Fixation Orthosis; KWQ<br>• 21 CFR 888.3070 Pedicle Screw System; MNH, MNI, NKB, OSH |
| | 2. MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS<br>For use with StealthStation® and IPC® POWEREASE™ Systems<br>• Class II<br>• 21 CFR 882.4560 Stereoitaxic Instruments; OLO<br>• 21 CFR 882.4310 Drills, Burs, Trephines & Accessories (Simple, Powered); HBE |
| | |
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| | |
| | |
| | |
| 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<br>11/25/2013) |
| • | K102555 CD HORIZON® Spinal System (S.E<br>11/17/2010) |
| • | K141605 CD HORIZON® Spinal System (S.E 7/14/2014) |
| 2. | MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS<br>For use with StealthStation® and IPC® POWEREASE™<br>Systems |
| • | K140454 Navigated Instruments (S.E 5/22/2014) |
| | The predicates have not been subject to a design related<br>recall. |
| | 1. The CD HORIZON® Spinal System consists of a variety of<br>shapes and sizes of rods, hooks, screws, CROSSLINK®<br>plates, staples and connecting components, as well as implant<br>components from other Medtronic spinal systems, which can<br>be rigidly locked into a variety of configurations, with each<br>construct being tailor-made for the individual case. The<br>subject devices include: |
| | |
| • | Bone screws |
| • | Rods |
| • | Set Screws |
| • | Extender |
| • | Extender Cap |
| Description of Device | • Accessories, case, caddies trays, and lids which may be<br>used to transport and sterilize the subject implants and<br>instruments. |
| | |
| | The subject CD HORIZON® Spinal System device will be<br>available in similar sizes as the predicate systems. |
| | 2. MEDTRONIC NAVIGATED REUSABLE<br>INSTRUMENTS For use with StealthStation® and IPC®<br>POWEREASE™ Systems |
| | Medtronic Navigated Reusable Screwdriver is a spine<br>preparation instrument made of high grade stainless steel.<br>This instrument was specifically designed for use in<br>procedures where the use of stereotactic surgery may be |
| | appropriate. Placing Medtronic single-use sterile spheres<br>on each of the NavLock™ Tracker passive stems allows a<br>Medtronic computer-assisted surgery system such as the<br>StealthStation® Image Guidance System to track the<br>instruments in the surgical field.<br><br>Medtronic Navigated Reusable Screwdriver is compatible<br>with various Medtronic spinal implant systems. This<br>screwdriver is also compatible with Medtronic's IPC®<br>POWEREASET™ System when connected to the<br>POWEREASET™ Driver. |
| Indications for Use | 1. CD HORIZON® Spinal System<br>The CD HORIZON® Spinal System with or without<br>SEXTANT® instrumentation is intended for posterior,<br>non-cervical fixation as an adjunct to fusion for the<br>following indications: degenerative disc disease (defined<br>as back pain of discogenic origin with degeneration of the<br>disc confirmed by history and radiographic studies),<br>spondylolisthesis, trauma (i.e., fracture or dislocation),<br>spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or<br>lordosis), tumor, pseudarthrosis, and/or failed previous<br>fusion. |
| | Except for hooks, when used as an anterolateral<br>thoracic/lumbar system, the CD HORIZON® Spinal<br>System may also be used for the same indications as an<br>adjunct to fusion.<br><br>With the exception of degenerative disc disease, the CD<br>HORIZON® LEGACY™ 3.5mm rods and the CD<br>HORIZON® Spinal System PEEK rods and associated<br>components may be used for the aforementioned<br>indications in skeletally mature patients as an adjunct to<br>fusion. The 3.5mm rods may be used for the specific<br>pediatric indications noted below. |
| | When used for posterior non-cervical pedicle screw<br>fixation in pediatric patients, the CD HORIZON® Spinal<br>System implants are indicated as an adjunct to fusion to<br>treat progressive spinal deformities (i.e., scoliosis, |
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| | | 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 |
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| | 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<br>Technological<br>Characteristics with the<br>Predicate Devices: | The CD HORIZON® Spinal System has the same<br>fundamental technology, cobalt chrome, titanium and stainless<br>steel material as the predicate devices. The predicate and<br>subject devices are intended to help provide immobilization<br>and stabilization of spinal segments as an adjunct to fusion of<br>the thoracic lumbar and/or sacral spine.<br>K142847 CD HORIZON® Spinal System (S.E.<br>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<br>11/25/2013) K102555 CD HORIZON® Spinal System (S.E<br>11/17/2010) K141605 CD HORIZON® Spinal System (S.E 7/14/2014) 2. MEDTRONIC NAVIGATED REUSABLE<br>INSTRUMENTS For use with StealthStation® and IPC®<br>POWEREASET™ Systems<br><br>The subject Medtronic Navigated Reusable Instrument for use<br>with StealthStation® and IPC® POWEREASET™ Systems<br>has the same fundamental technology and stainless steel<br>material as the predicate devices. The predicate and subject<br>devices are intended to be used during the preparation and<br>placement of Medtronic screws during spinal surgery to assist<br>the surgeon in precisely locating anatomical structures in<br>either open, or minimally invasive, procedures. Medtronic<br>Navigated Reusable Instruments are specifically designed for<br>use with the StealthStation® System, which is indicated for<br>any medical condition in which the use of stereotactic surgery<br>may be appropriate, and where reference to a rigid anatomical<br>structure, such as a skull, a long bone, or vertebra, can be<br>identified relative to a CT or MR-based model, fluoroscopy<br>images, or digitized landmarks of the anatomy. Medtronic |
| | Navigated Reusable Instruments are also compatible with the |
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| Performance Data: | IPC® POWEREASET™ System.<br>K140454 Navigated CD HORIZON® Instruments (S.E<br>5/22/2014)<br>The following performance data were provided in support of<br>substantial equivalence. |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility<br>The biocompatibility evaluation for the CD HORIZON®<br>Spinal System devices was conducted in accordance with<br>FDA's Draft Guidance for Industry and FDA Staff "Use of<br>International Standard ISO-10993, Biological Evaluation of<br>Medical Devices Part 1: Evaluation and Testing" issued April,<br>23, 2013. |
| | The subject CD HORIZON® Spinal System bone screws,<br>rods, and set screws are permanent implants and will be<br>classified as permanent , >30 day body contact according to<br>with FDA's Draft Guidance for Industry and FDA Staff "Use<br>of International Standard ISO-10993, Biological Evaluation of<br>Medical Devices Part 1: Evaluation and Testing". The subject<br>bone screws are manufactured from identical materials as the<br>predicate devices, in accordance with the following ASTM<br>standards: |
| | • ASTM F1537 – Standard Specification for<br>Wrought Cobalt-28-Chromium-6-Molybdenum<br>Alloys for Surgical Implants |
| | • ASTM F67 - Specification for Unalloyed Titanium<br>for Surgical Implant Applications |
| | • ASTM F136 - Standard Specification for Wrought<br>Titanium-6 Aluminum-4 Vanadium ELI (Extra<br>Low Interstitial) Alloy for Surgical Implant<br>Applications |
| | The subject rods are manufactured from identical materials as<br>the predicate devices, in accordance with the following<br>ASTM standards: |
| | • ASTM F1537 – Standard Specification for<br>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<br>Alloy, and medical grade stainless steel have a long history of<br>safe and effective use in spinal surgery and biocompatibility<br>testing is not required and not testing was conducted. |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <b>Mechanical Testing</b> |
| | In accordance with, Guidance for Industry and FDA Staff –<br>Spinal System 510(k)’s”, Medtronic has evaluated the subject<br>devices to demonstrate substantial equivalence to the<br>predicate devices. It was determined that subject devices do<br>not represent a new worst case. Engineering rationales were<br>used to demonstrate substantial equivalence. |
| | Based on the risk analysis, test results, and additional<br>supporting documentation provided in the pre-market<br>notification, the subject CD HORIZON® Spinal System<br>is substantially equivalent to the following predicates: |
| Conclusion: | • K142847, K091974, K113529, K132639,<br>K102555, K141605 |
| | |
| | The MEDTRONIC NAVIGATED REUSABLE<br>INSTRUMENTS are substantially equivalent to<br>the following predicate: |
| | |
| | • K140454 |
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
