(29 days)
No
The device description and intended use clearly describe a mechanical spinal fixation system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies section focuses on compliance with material and mechanical standards, not algorithmic performance.
Yes
The device is described as a "posterior spinal fixation system" intended for "immobilization and stabilization of spinal segments" as an "adjunct to fusion" in the treatment of various spinal instabilities or deformities. These uses clearly aim to treat or alleviate a medical condition, which falls under the definition of a therapeutic device.
No
The device is a posterior spinal fixation system, which is used for immobilization and stabilization of spinal segments, not for diagnosis.
No
The device description explicitly states it is a "top-loading, multiple component, posterior spinal fixation system which consists of cannulated and non-cannulated pedicle screws, straight and pre-curved rods, and locking cap screws." These are physical hardware components, not software.
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 surgical implant system for stabilizing the spine in skeletally mature patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and locking caps made from medical-grade materials. These are surgical instruments and implants, not reagents, analyzers, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The Sure-Lok C Extended Tab PSS 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 following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Sure-Lok C Extended Tab Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
Product codes
MNI, MNH
Device Description
The Sure-Lok C Extended Tab PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of cannulated and non-cannulated pedicle screws, straight and pre-curved rods, and locking cap screws. All components are available in a variety of sizes to match more closely the patient's anatomy. The Sure-Lok C Extended Tab PSS System is suitable for the following procedures: open, mini-open, percutaneous MIS approach, or a combination of any during the same procedure. All components are made from medical grade stainless steel, titanium or titanium alloy which comply with such standards as ASTM F-138, ASTM F-136, ISO5832-1 or ISO5832-3. All components are supplied clean and "NON STERILE."
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
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)
Consistent with FDA's guidance document entitled "Use of Standards in Substantial Equivalence Determinations" (March 12, 2000) and "Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards" (September 17, 2007), Precision Spine is including this statement that the Sure-Lok C Extended Tab Pedicle Screw System complies with the following recognized standards instead of providing the test reports demonstrating compliance with these standards: ASTM F-138, ASTM F-136, ISO5832-1, ISO5832-3, and ASTM F1717-12. These are the same standards with which the cleared Pedicle Screw System's, K092128 and K073240, complied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Precision Spine / Spinal USA PSS System (K092128), Precision Spine/Spinal USA PSS System (K073240)
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.
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JUN 2 6 2014
K141397 Page 1 of 4
510(k) SUMMARY
| Submitter Name: | Precision Spine, Inc. |
|---|---|
| Submitter Address: | 2050 Executive Drive |
| Pearl, MS 39208 | |
| Submitter Contact | |
| Information: | Tel: 601-420-4244 ext. 128 |
| Fax: 601-420-4033 | |
| Email: mike.dawson@precisionspineinc.com | |
| Submitter Contact Person: | Michael C. Dawson, Esq. |
| Date Summary Prepared: | May 27, 2014 |
| Device Trade or Proprietary | |
| Name: | Sure-Lok C Extended Tab Pedicle Screw System |
| Common Name: | Orthosis, Pedicle Screw Spinal System |
| Classification Name: | Pedicle Screw System, Class II per 21 C.F.R. § |
| 888.3070 | |
| Product Codes | MNI |
| MNH | |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicated Devices: | Precision Spine / Spinal USA PSS System (K092128) |
| Precision Spine/Spinal USA PSS System (K073240) | |
| Type of Submission: | Special 510(k) |
| Basis for Submission: | Modification |
Device Description:
The Sure-Lok C Extended Tab PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of cannulated and non-cannulated pedicle screws, straight and pre-curved rods, and locking cap screws. All components are available in a variety of sizes to match more closely the patient's anatomy. The Sure-Lok C Extended Tab PSS System is suitable for the following procedures: open, mini-open, percutaneous MIS approach, or a combination of any during the same procedure. All components are made from medical grade stainless steel, titanium or titanium alloy which comply with such standards as ASTM F-138, ASTM F-136, ISO5832-1 or ISO5832-3. All components are supplied clean and "NON STERILE."
1
Indications For Use:
The Sure-Lok C Extended Tab Pedicle Screw 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 following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Sure-Lok C Extended Tab Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
Performance Data:
Consistent with FDA's guidance document entitled "Use of Standards in Substantial Equivalence Determinations" (March 12, 2000) and "Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards" (September 17, 2007), Precision Spine is including this statement that the Sure-Lok C Extended Tab Pedicle Screw System complies with the following recognized standards instead of providing the test reports demonstrating compliance with these standards: ASTM F-138, ASTM F-136, ISO5832-1, ISO5832-3, and ASTM F1717-12. These are the same standards with which the cleared Pedicle Screw System's, K092128 and K073240, complied.
A Data Standards Form (FDA Form 3654) is provided in Section 21 herein for each listed recognized consensus standard.
Change From Predicate:
The purpose of this submission is to make modifications to the components of the Pedicle Screw System cleared in K092128 and K073240. The standard construct is modified by the slightly increasing the length of the extended tab screw. In addition, the edges of the rods have been modified from being chamfered on both edges to tapered on one end and hex on the other end. The hex end provides optimal engagement in the rod inserter for insertion into the extended tab pedicle screw.
The Sure-Lok C Extended Tab Pedicle Screw System has the same intended use and fundamental scientific technology as our previously cleared Pedicle Screw System devices. The primary changes are:
2
-
- Long-Arm Cannualeted Screw:
The Long-Arm cannulated screw (SLCLXXX) was cleared under K092128. The following are descriptions of key features of the proposed extended tab screw as compared to the predicate device:
- Long-Arm Cannualeted Screw:
The size offerings are identical. Proposed extended tab screw is also made from Ti-6AI-4V ELI per ASTM F136 and type II color anodized. The assembly process and subcomponents are the same with the exception of the tulip design (head part on the drawing). The length of the tab has been The tulips have the same outer diameter, the same tulip increased. geometry, thread form. The height of the tulip that will remain implanted after the tabs are removed has not changed and is identical to the predicate. The proposed extended tab screw is slightly longer and the proximal geometry differs. These tabs are removed once the set screws have been tightened to their final torque. This change is made to support optional surgical approaches. This modification does not have implications on the function of the final construct.
- The straight and lordotic rods:
Ø5.5mm Straight and lordotic rods were originally cleared under K073240. The following are descriptions of key features of the proposed straight and ' lordotic rods as compared to the predicate device:
All predicate and proposed rods are offered in Ø5.5mm diameter. The predicate straight rods (110-5XXX) are offered from 40mm-160mm in 10mm increments, as well as 180mm, 200mm, 250mm, 400mm, and 450mm. The proposed straight rods (48-ST-55XXX) are 35-80mm in 5mm increments, 90-130 in 10mm increments, as well as 200mm and 300mm lengths. The predicate lordotic rods (100-5XXX) are offered from 35-80mm in 5mm increments, 90-150mm in 10mm increments, as well as 180mm and 200mm lengths. The proposed lordotic rods (48-CU-55XXX) are offered from 35-80 in 5mm increments and 90-150mm in 10mm increments. The predicate rods have chamfered edges. The proposed rods have one tapered end and one hex end. The hex end engages the rod inserter (48-9005) for insertion into the extended tab pedicle screw. When implanted, the placement of the set screw will be medial to the hexend and tapered end, therefore the ends will not be load bearing and do not affect the strength of the construct. This chage is made to provide optimal engagement with the rod inserter and the rods. This modification does not have implications on the function of the final construct.
3
Substantial Equivalence:
Sure-Lok C Extended Tab Pedicle Screw System has the same intended use and similar indications, principles of operation, and technological characteristics as the Pedicle Screw Systems. The minor differences in the Sure-Lok C Extended Tab Pedicle Screw System do not raise any new questions of safety or effectiveness. Thus, the Sure-Lok C Extended Tab Pedicle Screw System is substantially equivalent to its predicate devices.
Conclusion:
The overall technology characteristics and mechanical performance data lead to the conclusion that the Sure-Lok C Extended Tab Pedicle Screw System is substantially equivalent to predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes, possibly representing human figures or abstract forms, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
Precision Spine, Incorporated Mr. Michael Dawson Director of Regulatory Affairs 2050 Executive Drive Pearl, Mississippi 39208
Re: K141397
Trade/Device Name: Sure-Lok C Extended Tab Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI. MNH Dated: May 27, 2014 Received: May 28. 2014
Dear Mr. Dawson:
We have reviewed vour 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 11 (Special Controls) or class 111 (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
5
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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 on last page
510(k) Number (if known)
Device Name Sure-Lok C Extended Tab Pedicie Screw System
Indications for Use (Describe)
The Sure-Lok C Extended Tab PSS 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 following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
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) (Signalure)
Zane Wallywatt Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (1/14)
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