(80 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system components (screws, rods, connectors). There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various spinal conditions, indicating it is used for therapeutic purposes.
No
Explanation: The device is described as a spinal fixation system (implants like screws, rods, and connectors) intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is used in the treatment of instabilities or deformities, not for diagnosing them.
No
The device description explicitly states it is a "toploading spinal fixation system including screws, rods, and connectors" manufactured from titanium alloy and cobalt chrome. This indicates it is a hardware-based implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Proliant System Function: The Proliant System is a surgical implant designed to provide structural support and stabilization to the spine. It is physically implanted into the patient's body.
- Intended Use: The intended use clearly states it's for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample.
- Device Description: The description details physical components like screws, rods, and connectors made of metal alloys, which are typical for surgical implants, not diagnostic devices.
The Proliant System is a surgical implant/device used in the treatment of spinal conditions, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Proliant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP
Device Description
The ChoiceSpine Proliant Posterior Pedicle Screw and Hook Fixation System is a toploading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar, and sacral spine. Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and Cobalt Chrome (Co-28Cr-6Mo per ASTM F1537) in various sizes. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
hospital, operating room
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 proposed Proliant System line extensions have been tested in the following test modes.
- Static axial compression bending per ASTM F1717-14 o
- Static torsion per ASTM F1717-14
- Dynamic axial bending per ASTM F1717-14
The results of this non-clinical testing show the strength of the Proliant Posterior Pedicle Screw and Hook Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
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
Choice Spine, LP % Jim Banic Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
June 8, 2017
Re: K170821
Trade/Device Name: ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: March 17, 2017 Received: March 20, 2017
Dear Mr. Banic:
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
1
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 (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.
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) | K170821 |
|---|---|
| Device Name | Choice Spine™ Proliant® Posterior Pedicle Screw and Hook Fixation System |
| Indications for Use (Describe) | The Proliant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. |
| The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis). | |
| 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.
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 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSU Publishing Services (full) 441-6740 EF
3
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System Traditional 510(k)
510(k) Summary
| Company: | Choice Spine, LP
400 Erin Drive
Knoxville, TN 37919 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 19, 2017 |
| Contact Person: | Jim Banic
Sr. Regulatory Affairs Specialist |
| | Phone: (352) 327-4673
Fax: (352) 378-2617 |
| Proprietary Name: | ChoiceSpine™ Proliant® Posterior Pedicle Screw and
Hook Fixation System |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification Name: | 21 CFR 888.3070, Orthosis, Spinal Pedicle Fixation
21 CFR 888.3070, Orthosis, Spondyloisthesis Spinal
Fixation
21 CFR 888.3050, Appliance, Fixation Interlaminal |
| | Class II |
| Product Codes: | NKB and KWP |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Proliant® Pedicle Screw System | ||
| (Primary Predicate) | Exactech, Inc. | K102870 |
| Expedium Spine System | DePuy Synthes |
Device Description
The ChoiceSpine Proliant Posterior Pedicle Screw and Hook Fixation System is a toploading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar, and sacral spine. Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and Cobalt Chrome (Co-28Cr-6Mo per ASTM F1537) in various sizes. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
Indications for Use
The Proliant System is intended to provide immobilization and stabilization of spinal
4
segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).
Submission Purpose
The purpose of this 510(k) submission is to all line extensions to the existing Proliant Pedicle Screw System, and to change the name from the Exactech Proliant Pedicle Screw System to the ChoiceSpine Proliant Pedicle Screw System
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
. Intended Use/Indications for Use.
Proliant Polyaxial Pedicle Screw and Hook Fixation System have similar indications for use and intended uses as its predicate device.
. Materials
Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Polyaxial Pedicle Screw System are composed of titanium alloy (Ti-6Al-4V) per ASTM F136 and cobalt chrome per ASTM F1537, biocompatible materials conforming to a recognized industry standard for permanent implants.
Design Features .
Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Pedicle Screw System have similar design features.
. Dimensions
Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant System are dimensionally comparable.
. Packaging and Sterilization
Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Pedicle Screw System are provided non-sterile, for single use only, and will be steam sterilized by the hospital prior to use in the operating room using the same sterilization method.
- Device Shelf Life ●
5
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System K170821 Traditional 510(k) Page 3 of 3
Neither Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Pedicle Screw System have shelf life expiration dating.
. Performance specifications
The proposed Proliant System line extensions have been tested in the following test modes.
- Static axial compression bending per ASTM F1717-14 o
- 0 Static torsion per ASTM F1717-14
- o Dynamic axial bending per ASTM F1717-14
The results of this non-clinical testing show the strength of the Proliant Posterior Pedicle Screw and Hook Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Substantial Equivalence Conclusion
Results from mechanical tests and biomechanical assessment demonstrate the proposed Proliant Posterior Pedicle Screw and Hook System is substantially equivalent to the predicate Proliant Pedicle Screw System.