(66 days)
Not Found
No
The document describes a spinal fixation system and associated surgical instruments, including navigated instruments used with a stereotactic system. While navigation systems utilize image processing and spatial tracking, there is no mention of AI or ML being used for analysis, decision support, or any other function within the device or its associated systems. The performance studies focus on mechanical testing and software verification, not AI/ML model validation.
Yes
This device, the CD HORIZON® Spinal System, is intended for posterior, non-cervical fixation as an adjunct to fusion for a variety of medical conditions such as degenerative disc disease, spondylolisthesis, trauma, and spinal deformities, clearly indicating its use in treating and managing medical conditions. This falls within the definition of a therapeutic device. Additionally, the description of various components (e.g., rods, screws, plates) and their use in surgical procedures further supports its therapeutic intent.
No
Explanation: The provided text describes several spinal systems and instruments (CD HORIZON® Spinal System, IPC® System, Medtronic Navigated Reusable Instruments) which are used for surgical procedures like fixation, cutting, drilling, and guiding screw placement. None of these functions are diagnostic in nature; they are all interventional or surgical tools.
No
The device description clearly lists various hardware components such as rods, hooks, screws, plates, staples, connecting components, and instruments. While some instruments are compatible with software-driven systems (STEALTHSTATION® and IPC® POWEREASE®), the core device being described is a spinal implant system and associated hardware instruments.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CD HORIZON® Spinal System and its associated components and instruments are used for surgical procedures involving the spine. They are implants and surgical tools used in vivo (within the body) to provide structural support, fixation, and facilitate fusion.
- Intended Use: The intended use clearly describes surgical procedures for treating various spinal conditions.
- Device Description: The device description details implants (rods, hooks, screws, etc.) and surgical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the CD HORIZON® Spinal System and its related components are medical devices used for surgical treatment, 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 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® LEGACYTM 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWO, OLO, HWE
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 in this submission include:
Additions to the existing CD HORIZON® SOLERA® Ø5.5/6.0 Spinal System
- Ø5.5/6.0 Awl Tap Screws (ATS)
- Ø5.5 Capped Rods
- Ø5.5 Percutaneous Rods
Additions to the existing CD HORIZON® SOLERA® VOYAGER™ Ø4.75 Spinal System
- Ø4.75 Awl Tap Screws (ATS)
Creating the new CD HORIZON® SOLERA® VOYAGER™ Ø5.5/6.0 Spinal System
- Cannulated Multi-Axial Screws (MAS)
- Awl Tap Screws (ATS)
- Capped Rods
- Percutaneous Rods
- Tab Extenders
- Extender Cap
- Taps and Driver compatible with IPC® POWEREASE® System
- Navigated Driver compatible with STEALTHSTATION® and IPC® POWEREASE® Systems
- System specific cases and trays
Medtronic Reusable Instruments Only Compatible with the IPC® POWEREASE® System
The subject Medtronic Reusable taps and driver are spine preparation instruments made of high grade stainless steel. The subject taps and driver are compatible with Medtronic's IPC® POWEREASE® System and may be connected to the IPC® POWEREASE® handpiece. The subject taps and driver can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.
Medtronic Reusable Instruments Compatible with the STEALTHSTATION® System and IPC® POWEREASE® Systems
The subject Medtronic Navigated Reusable driver 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. The subject driver is also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (posterior, non-cervical, T1-S1), skull, long bone, vertebra
Indicated Patient Age Range
Skeletally mature patients, pediatric patients (for specific indications)
Intended User / Care Setting
Surgeon, surgical settings (open, minimally invasive)
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)
Validation Testing
To support the expanded intended use for the Predicate 2 (K141494, S.E. 08/06/2014) CD HORIZON® SOLERA® Ø4.75 ATS, subject CD HORIZON® SOLERA® Ø5.5/6.0 ATS, CD HORIZON® SOLERA® VOYAGER® Ø4.75 and CD HORIZON® SOLERA® VOYAGER® Ø5.5/6.0 ATS, a pre-clinical confirmatory validation activity was conducted in cadaver models which demonstrated that the proposed ATS devices could be used for percutaneous use. For the remainder of the subject devices, Medtronic believes that the existing validation activities performed for the predicate devices are sufficient for establishing substantial equivalence.
Mechanical Testing
In accordance with the 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. Medtronic believes that testing is not warranted for the subject implants, subject instruments compatible with IPC® POWEREASE® System and subject Tab Extenders and Extender Cap as they do not present a new worst case when compared to the predicate devices.
For the subject instruments compatible with STEALTHSTATION® System and IPC® POWEREASE™ Systems, software verification testing and activities were performed that demonstrated that the subject instruments performed as intended.
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.
K113174, K141494, K143375, K132639, K121680, K122862, K113529, K153463, K111520, K140454, K124004
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek Ms. Kanesha Hines Regulatory Affairs Specialist 1800 Pvramid Place Memphis. Tennessee 38132
Re: K170679
Trade/Device Name: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems Regulation Number: 21 CFR 888.3070
May 11, 2017
Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO, OLO, HWE Dated: March 3, 2017 Received: March 6, 2017
Dear Ms. Hines:
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
1
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 devicerelated 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/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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number ( if known ) | K170679 |
|---|---|
| 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 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® LEGACYTM 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, 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 ) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (8/14) Page of
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4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K170679 |
|---|---|
| Device Name | MEDTRONIC REUSABLE INSTRUMENTS FOR USE WITH THE IPC® POWEREASE® SYSTEM |
| Indications for Use (Describe) | IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. |
| The IPC® POWEREASE® System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
"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."
| FORM FDA 3881 (1/14) | Page-1-of-1- | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | -------------- | ---------------------------------------- | ---- |
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| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|---|
| Expiration Date: January 31, 2017 | Food and Drug Administration | |
| See PRA Statement below. | Indications for Use | |
| 510(k) Number (if known) | K170679 | |
| Device Name | MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS FOR USE WITH STEALTHSTATION® AND IPC® POWEREASET™ SYSTEMS | |
| 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® POWEREASET™ System. | |
| Type of Use (Select one or both, as applicable) | ||
| 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."
FORM FDA 3881 (1/14)
Page-1-of-1-
PSC Publishing Services (301) 443-6740
EF
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4
6
510(k) SUMMARY
MEDTRONIC
CD HORIZON® Spinal System
| Submitter: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kanesha Hines
Regulatory Affairs Specialist
Direct Telephone: (901)399-2670 |
| Date Prepared | May 4, 2017 |
| Name of Device | CD HORIZON® Spinal System, Medtronic Reusable Instruments
for Use with the IPC® POWEREASE® System, Medtronic
Navigated Reusable Instruments for Use with the
STEALTHSTATION® and IPC® POWEREASET™ Systems |
| Common Name | Bone Screws, Pedicle Screws, Taps, Drivers, Tab Extenders,
Extender Cap, and Accessories |
| Classification Name | CD HORIZON® Spinal System
Thoracolumbosacral Pedicle Screw System - NKB, KWQ, KWP
Medtronic Navigated Taps and Screwdrivers
Stereotaxic Instrument - OLO
IPC® POWEREASE® System
Surgical Instrument Motors and Accessories/Attachments -
HWE |
| Classification | Class II (Implants)
Class II (Instruments/Accessories) |
| Product Codes | NKB, KWP, KWQ (Bone Screws)
21 CFR 888.3070
21 CFR 888.3060
21 CFR 888.3050
OLO (Navigated Instruments)
21 CFR 882.4560
HWE (IPC® POWEREASE® Compatible Instruments)
21 CFR 878.4820 |
7
| Predicate Devices | There are 11 Predicates.
CD HORIZON® Spinal System
Primary Predicate 1- K113174 CD HORIZON® SOLERA®
Ø5.5/6.0mm (S.E. 11/21/2011)
Predicate 2- K141494 CD HORIZON® SOLERA® Ø4.75 ATS
(S.E. 08/06/2014)
Predicate 3- K143375 CD HORIZON® SOLERA®
VOYAGER™ 4.75 Spinal System (S.E. 02/13/2015)
Predicate 4- K132639 CD HORIZON® Prebent Rods and Rod
Inserter (S.E. 11/25/2013)
Predicate 5- K121680 CD HORIZON® SOLERA® Additional
Rods (S.E. 07/05/2012)
Predicate 6- K122862 CD HORIZON® Longitude II and
Additional Rods (S.E. 10/03/2012
Predicate 7- K113529 CD HORIZON® VOYAGER™ 5.5
Spinal System (S.E. 02/09/2012)
IPC® POWEREASE® System
Predicate 8- K153463 CD HORIZON® Taps Compatible with
IPC® POWEREASE® System (S.E. 12/30/2015)
Predicate 9- K111520 CD HORIZON® Reusable Instruments
Compatible with IPC® POWEREASE® System (S.E.
10/26/2011)
Medtronic Navigated Taps and Screwdrivers
Predicate 10- K140454 Navigated CD HORIZON® SOLERA®
Screwdriver/Taps (S.E. 05/22/2014)
Predicate 11- K124004 Medtronic Navigated Taps and
Screwdrivers (S.E. 03/22/2013) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of Devices | The predicates have not been subject to a design related recall.
CD HORIZON® Spinal System
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 in this submission include: |
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Additions to the existing CD HORIZON® SOLERA® Ø5.5/6.0 Spinal System ● Ø5.5/6.0 Awl Tap Screws (ATS) ● Ø5.5 Capped Rods ● Ø5.5 Percutaneous Rods Additions to the existing CD HORIZON® SOLERA® VOYAGER™ Ø4.75 Spinal System . Ø4.75 Awl Tap Screws (ATS) Creating the new CD HORIZON® SOLERA® VOYAGER™ Ø5.5/6.0 Spinal System ● Cannulated Multi-Axial Screws (MAS) ● Awl Tap Screws (ATS) ● Capped Rods Percutaneous Rods ● ● Tab Extenders Extender Cap ● . Taps and Driver compatible with IPC® POWEREASE® System . Navigated Driver compatible with STEALTHSTATION® and IPC® POWEREASE® Systems . System specific cases and trays Medtronic Reusable Instruments Only Compatible with the IPC® POWEREASE® System The subject Medtronic Reusable taps and driver are spine preparation instruments made of high grade stainless steel. The subject taps and driver are compatible with Medtronic's IPC® POWEREASE® System and may be connected to the IPC® POWEREASE® handpiece. The subject taps and driver can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece. Medtronic Reusable Instruments Compatible with the STEALTHSTATION® System and IPC® POWEREASE® Systems The subject Medtronic Navigated Reusable driver 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. The subject driver is also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC®
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| POWEREASE® handpiece or the NavLock™ tracker. | |
|---|---|
| CD HORIZON® Spinal System | |
| The subject devices have identical indications to the most recently | |
| cleared CD HORIZON® Spinal System indications in K162379 | |
| (S.E. 11/16/2016) | |
| 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, 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 adolescent | |
| idiopathic scoliosis. Additionally, the CD HORIZON® Spinal | |
| System is intended to treat pediatric patients diagnosed with the | |
| following conditions: spondylolisthesis/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. | |
| Medtronic Reusable Instruments Compatible with the IPC® | |
| POWEREASE® System | |
| The subject devices have identical indications to the those cleared | |
| in K143019 (S.E. 04/08/2015) | |
| IPC® System is indicated for the incision/cutting, removal, | |
| drilling and sawing of soft and hard tissue and bone, and | |
| biomaterials in Neurosurgical (Cranial, Craniofacial), | |
| Orthopedic, Arthroscopic, Spinal, Sternotomy, and General | |
| surgical procedures. | |
| The IPC® POWEREASE® System is indicated for drilling, | |
| tapping and driving screws and working end attachments during | |
| spinal surgery, including open and minimally invasive procedures. | |
| It is also used in placement or cutting of screws, posts and rods. | |
| Medtronic Reusable Instruments Compatible with the | |
| STEALTHSTATION® System and IPC® POWEREASE® | |
| System | |
| The subject devices have identical indications to those cleared in | |
| K140454 (S.E. S.E. 05/22/2014). | |
| 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. | |
| CD HORIZON® Spinal System | |
| The primary predicate for the CD HORIZON® Spinal System is | |
| the predicate CD HORIZON® Spinal System (K113174, S.E. | |
| 11/21/2011). The subject CD HORIZON® Spinal System devices | |
| have the same or similar indications, intended use, and similar | |
| materials as the following FDA cleared Primary Predicate 1 | |
| K113174, (S.E. 11/21/2011), Predicate 2 K141494 (S.E. | |
| 11/21/2011), Predicate 3 K143375 (S.E. 02/13/2015), Predicate 4 | |
| Comparison of | |
| Technological | |
| Characteristics with the | |
| Predicate Devices | |
| Performance Data | K132639 (S.E. 11/25/2013), Predicate 5 K121680 (S.E. 07/05/2012), Predicate 6 K122862 (S.E. 10/03/2012), and |
| Predicate 7 K113529 (S.E. 02/09/2012). The predicate and subject devices have the identical function and scientific fundamental technology. | |
| Medtronic Reusable Instruments for Use with the IPC® | |
| POWEREASE® System | |
| The subject taps and driver are identical in intended use and material as their predicates in Predicate 8 K153463 (S.E. 12/30/2015) and Predicate 9 K111520 (S.E. 10/26/2011). The difference between the subject and predicate driver and taps is that the subject driver and taps are designed to interface with the subject bone screws. | |
| Medtronic Navigated Reusable Instruments for Use with | |
| STEALTHSTATION® System and IPC® POWEREASE™ Systems | |
| The subject navigated driver that is compatible with the STEALTHSTATION® System and IPC® POWEREASE™ Systems is identical to its predicate (K124004, S.E. 03/22/2013 and K140454, S.E. 05/22/2014) in intended use and materials. The difference between the subject and predicate driver is that it is designed to interface with the subject bone screws. | |
| The following performance data were provided in support of substantial equivalence. | |
| Validation Testing | |
| To support the expanded intended use for the Predicate 2 (K141494, S.E. 08/06/2014) CD HORIZON® SOLERA® Ø4.75 ATS, subject CD HORIZON® SOLERA® Ø5.5/6.0 ATS, CD HORIZON® SOLERA® VOYAGER® Ø4.75 and CD HORIZON® SOLERA® VOYAGER® Ø5.5/6.0 ATS, a pre-clinical confirmatory validation activity was conducted in cadaver models which demonstrated that the proposed ATS devices could be used for percutaneous use. For the remainder of the subject devices, Medtronic believes that the existing validation activities performed for the predicate devices are sufficient for establishing substantial equivalence. | |
| Mechanical Testing | |
| In accordance with the 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. | |
| Medtronic believes that testing is not warranted for the subject | |
| implants, subject instruments compatible with IPC® | |
| POWEREASE® System and subject Tab Extenders and Extender | |
| Cap as they do not present a new worst case when compared to the | |
| predicate devices. | |
| For the subject instruments compatible with | |
| STEALTHSTATION® System and IPC® POWEREASE™ | |
| Systems, software verification testing and activities were | |
| performed that demonstrated that the subject instruments | |
| performed as intended. | |
| Based on the test results and additional supporting information | |
| provided in this premarket notification, Medtronic believes the | |
| subject devices are at least as safe as and effective as the legally | |
| marketed predicate devices: | |
| Conclusion | • Primary Predicate 1- K113174 CD HORIZON® |
| SOLERA® Ø5.5/6.0mm (S.E. 11/21/2011) | |
| • Predicate 2- K141494 CD HORIZON® SOLERA® Ø4.75 | |
| ATS (S.E. 08/06/2014) | |
| • Predicate 3- K143375 CD HORIZON® SOLERA® | |
| VOYAGER™ 4.75 Spinal System (S.E. 02/13/2015) | |
| • Predicate 4- K132639 CD HORIZON® Prebent Rods and | |
| Rod Inserter (S.E. 11/25/2013) | |
| • Predicate 5- K121680 CD HORIZON® SOLERA® | |
| Additional Rods (S.E. 07/05/2012) | |
| • Predicate 6- K122862 CD HORIZON® Longitude II and | |
| Additional Rods (S.E. 10/03/2012 | |
| • Predicate 7- K113529 CD HORIZON® VOYAGER™ 5.5 | |
| Spinal System (S.E. 02/09/2012) | |
| • Predicate 8- K153463 CD HORIZON® Taps Compatible | |
| with IPC® POWEREASE® System (S.E. 12/30/2015) | |
| • Predicate 9- K111520 CD HORIZON® Reusable | |
| Instruments Compatible with IPC® POWEREASE® | |
| System (S.E. 10/26/2011) | |
| • Predicate 10- K140454 Navigated CD HORIZON® | |
| SOLERA® Screwdriver/Taps (S.E. 05/22/2014) | |
| • Predicate 11-K124004 Medtronic Navigated Taps and | |
| Screwdrivers (S.E. 03/22/2013) |
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