(92 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing standards.
No
The device, a spinal fixation system, is intended to stabilize spinal segments as an adjunct to fusion and to treat various spinal conditions, which falls under the definition of a therapeutic device as it treats or alleviates a disease or injury.
No
The device description clearly states that the Modular Spinal Fixation System is an internal fixation implant system, consisting of components like rods and screws, intended to stabilize and maintain alignment after surgery. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states it consists of physical components made of titanium alloy and cobalt chrome, such as rods, screws, and connectors. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "Internal fixation implant" used to "stabilize and maintain alignment until normal healing occurs." This describes a surgical implant used in the body, not a device used to test samples outside the body (in vitro).
- Device Description: The description details the physical components of the implant (rods, screws, etc.) and the materials they are made from. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used for spinal fixation.
N/A
Intended Use / Indications for Use
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.
The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the noncervical posterior spine in skeletally mature patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pediatric pediatic pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (8) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.
Product codes
NKB
Device Description
The Modular Spinal Fixation System consists of an assortment of rods, modular screws, modular tulips, cross connectors and offset connectors. The head and taper lock are assembled together during manufacturing to create the modular tulip assembly. The cross connectors are also assembled during manufacturing. The Modular Spinal Fixation System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Modular Spinal Fixation System components with components from any other system or manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, thoracic/lumbar spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for treatment of adolescent idiopathic scoliosis)
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)
Testing according to ASTM F543 & F1717 included Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending and Dissociation tests was presented to demonstrate the substantial equivalency of the Life Spine Nautilus K140457.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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March 13, 2019
Life Spine Inc. Ms. Angela Batker RA/QA Specialist 13951 South Ouality Drive Huntley, Illinois 60142
Re: K183430
Trade/Device Name: Modular Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: March 5, 2019 Received: March 6, 2019
Dear Ms. Batker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183430
Device Name Modular Spinal Fixation System
Indications for Use (Describe)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.
The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the noncervical posterior spine in skeletally mature patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pediatric pediatic pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (8) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.
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) |
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510(k) Summary Modular Spinal Fixation System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | March 13th, 2019 |
| Trade Name: | Modular Spinal Fixation System |
| Common Name: | Pedicle Screw Spinal System |
| Classification: | NKB, CFR 888.3070, Class II |
| Primary Predicate: | Orthofix Janus Spinal System (K171082) |
Additional Predicate: Life Spine Centerline Spinal System (K151196) Life Spine Nautilus Spinal System (K140457)
Device Description:
The Modular Spinal Fixation System consists of an assortment of rods, modular screws, modular tulips, cross connectors and offset connectors. The head and taper lock are assembled together during manufacturing to create the modular tulip assembly. The cross connectors are also assembled during manufacturing. The Modular Spinal Fixation System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Modular Spinal Fixation System components with components from any other system or manufacturer.
4
Intended Use of the Device:
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice® OccipitoCervicoThoracicFixation System's 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.
Technological Characteristics:
The Modular Spinal Fixation System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537. This this is the same material used in the predicate devices.
Performance Data:
Testing according to ASTM F543 & F1717 included Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending and Dissociation tests was presented to demonstrate the substantial equivalency of the Life Spine Nautilus K140457.
Substantial Equivalence:
The Modular Spinal Fixation System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of The Modular Spinal Fixation System.