(170 days)
No
The summary describes a mechanical spinal fixation system and associated surgical instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for various medical conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and/or failed previous fusion, which are all therapeutic interventions.
No
The device description and intended use clearly state that it is a surgical system (CD HORIZON® Spinal System) and associated instrumentation (IPC® POWEREASE™ System) used for non-cervical spinal fixation and surgical procedures, acting as an adjunct to fusion. Its purpose is to treat conditions like degenerative disc disease, spondylolisthesis, trauma, and curvatures, not to diagnose them.
No
The device description clearly outlines various hardware components like rods, hooks, screws, plates, staples, and connecting components, as well as surgical instruments. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for posterior, non-cervical spinal fixation as an adjunct to fusion for various spinal conditions. This is a surgical implant and instrumentation system used in vivo (within the body) during surgery.
- Device Description: The device description details rods, hooks, screws, plates, and connecting components, as well as surgical instruments for preparing the spine and placing implants. These are all physical devices used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a surgical implant and associated instrumentation, which falls under a different regulatory category than 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, 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. 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.
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE™ System is indicated for drilling, tapping 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.
Product codes
NKB, OSH, MNH, MNI, KWP, KWQ, 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.
-
MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System
The Medtronic Reusable drivers and taps that are compatible with Medtronic's IPC® POWEREASE® System are spine preparation instruments, which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), non-cervical pedicle
Indicated Patient Age Range
Skeletally mature patients, pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of substantial equivalence.
Biocompatibility
The subject CD HORIZON® drivers and taps that are compatible with the IPC® POWEREASE® System are instruments manufactured from: medical grade stainless steel per ASTM A564, Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes, ASTM F899, Standard Specification for Wrought Stainless Steel for Surgical Instruments, and ASTM A693, Standard Specification for Precipitation -Hardening Stainless Steel and Heat Resisting Steel Plate, Sheet and Strip. Stainless Steel (Custom 465 Stainless Steel or Custom 455 Stainless Steel) 17-4 Stainless Steel
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K141605 CD HORIZON® Spinal System, K111520 IPC® POWEREASE® System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
April 8, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Lila Joe Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K143019
Trade/Device Name: CD HORIZON® Spinal System, IPC® POWEREASE® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ, HWE Dated: March 9, 2015 Received: March 10, 2015
Dear Ms. Joe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K143019
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, 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. 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) |
|---|
| ------------------------------------------------- |
Z Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
3
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."
4
Indications for Use
510(k) Number (if known)
Device Name 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 (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE™ System is indicated for drilling, tapping 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)
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 CD HORIZON® Spinal System
April 2015
| Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lila Joe
Principal Regulatory Affairs Specialist
Direct Telephone: (901)399-2309 |
| Date Prepared | April 01, 2015 |
| Common Name | 1. CD HORIZON® Spinal System: Drivers and Taps
2. MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System: Drivers and Taps |
| 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 REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System Class II 21 CFR 878.4820: HWE |
6
| Regulatory Class,
Regulation Number,
Regulation Name, and
Device Product Code | Note: The subject drivers and taps are part of the CD HORIZON®
Spinal System. Therefore, the regulations and product codes for the
CD HORIZON® Spinal System are included as listed above. |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices | 1. CD HORIZON® Spinal System (Primary Predicate) K141605 CD HORIZON® Spinal System (S.E. 07/14/2014) 2. MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE
WITH THE IPC® POWEREASE® System K111520 IPC® POWEREASE® System (S.E. 10/26/2011) The predicates have not been subject to a design related recall. |
| Description of Device | 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.
- MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE
WITH THE IPC® POWEREASE® System
The Medtronic Reusable drivers and taps that are compatible
with Medtronic's IPC® POWEREASE® System are spine
preparation instruments, which are manufactured from materials
commonly used in orthopedic procedures which meet available
national or international standards specifications. The subject
taps and drivers may be connected to the POWEREASE® Driver
or used manually if desired. These instruments are also
compatible with various Medtronic spinal implant systems. |
7
| Indications for Use | 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, 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 |
8
| Indications for Use | 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. IPC® POWEREASE® System 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. |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics with
the Predicate Devices | 1. MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System The subject Medtronic CD HORIZON® Reusable drivers and taps that are Compatible with the IPC® POWEREASE® System have the same fundamental technology and stainless steel materials as the predicate devices. The Medtronic CD HORIZON® Reusable drivers and taps that are Compatible with Medtronic's IPC® POWEREASE® System are intended for use in surgical procedures to manipulate tissue, bone, or for use with other devices in orthopedic surgery. An instrument may be used for tapping or driving screws. An instrument may incorporate a measuring function which has uses |
9
| as described on the label and the instrument. | |
|---|---|
| K111520 IPC® POWEREASE® System | |
| Performance Data | The following performance data were provided in support of |
| substantial equivalence. | |
| Biocompatibility | |
| The subject CD HORIZON® drivers and taps that are compatible | |
| with the IPC® POWEREASE® System are instruments | |
| manufactured from : | |
| medical grade stainless steel per ASTM A564, Standard Specification for Hot-Rolled and | |
| Cold-Finished Age-Hardening Stainless Steel Bars and | |
| Shapes, ASTM F899, Standard Specification for Wrought | |
| Stainless Steel for Surgical Instruments, and ASTM A693, Standard Specification for Precipitation - | |
| Hardening Stainless Steel and Heat Resisting Steel Plate, | |
| Sheet and Strip. Stainless Steel (Custom 465 Stainless Steel or Custom 455 | |
| Stainless Steel) 17-4 Stainless Steel | |
| The subject CD HORIZON drivers and taps that are compatible with | |
| the IPC® POWEREASE® System are external communicating | |
| devices and are classified as limited, up to 24 hours of body contact | |
| according to FDA's Draft Guidance for Industry and FDA Staff: Use | |
| of International Standard ISO-10993, Biological Evaluation Method | |
| Devices Part 1: Evaluation and Testing, issued April 23, 2013. | |
| Conclusion | Based on the risk analysis, and additional supporting documentation |
| provided in the pre-market notification, the subject CD HORIZON® | |
| Spinal System is substantially equivalent to the following predicates: | |
| K141605 CD HORIZON® Spinal System (S.E 7/14/2014) K111520 IPC® POWEREASE® System (S.E. 10/26/2011) |