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.

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.

AI/ML Overview

The provided text (FDA 510(k) K183430 submission for the Modular Spinal Fixation System) describes the acceptance criteria and supporting studies for a spinal implant system, not an AI-powered medical device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, ground truth establishment) is not applicable or cannot be extracted from this document.

The document focuses on demonstrating the substantial equivalence of the new spinal fixation system to existing predicate devices based on design, materials, indications for use, and mechanical performance through bench testing.

Here's the information that can be extracted or deduced from the provided document, focused on the acceptance criteria and the study that proves the device meets them, insofar as they relate to a medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

For a spinal implant system like this, "acceptance criteria" primarily revolve around meeting established mechanical performance standards for spinal implants and demonstrating material biocompatibility, as well as being substantially equivalent to legally marketed predicate devices.

Acceptance Criteria (Bench Testing Standards)	Reported Device Performance/Findings
Mechanical performance according to ASTM F543 (Standard Specification for Metallic Medical Bone Screws)	"Testing according to ASTM F543... was presented to demonstrate the substantial equivalency of the Life Spine Nautilus K140457." (Indicates testing was performed and results supported substantial equivalence, implying the device met the mechanical requirements of F543 relevant to its components).
Mechanical performance according to ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)	"Testing according to ASTM... 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." (Indicates these specific tests were performed and results supported substantial equivalence, implying the device met the mechanical requirements of F1717).
Material Biocompatibility (as per ASTM F136 and ASTM F1537)	"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. This is the same material used in the predicate devices." (Implies acceptance based on use of medical-grade, standard materials with established biocompatibility, identical to predicates).
Substantial Equivalence to Predicate Devices (in terms of design, materials, indications for use, function, and mechanical performance)	"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." "The information presented demonstrates the substantial equivalency of The Modular Spinal Fixation System." (This is the overarching conclusion of the submission, indicating all criteria for substantial equivalence, supported by the data, were met).
Single Use Only / No Reuse	"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." (These are labeling and use instructions, critical for safety, and form part of the required compliance for acceptance).
Indicated for specific anatomical regions, patient populations, and conditions (non-cervical posterior spine, skeletally mature, pediatric AIS)	The "Indications for Use" section (Page 2 and 4) explicitly states these. Acceptance implies the device attributes (dimensions, strength, etc.) are appropriate for these indications, which is supported by the mechanical testing and substantial equivalence argument.
Use with autograft or allograft	"The Modular Spinal Fixation System is intended to be used with autograft or allograft." (Part of the accepted indications for use, implying compatibility and intended surgical practice are recognized).

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: This document does not specify exact sample sizes for the mechanical bench tests (e.g., number of implants tested). For mechanical tests per ASTM standards, a sufficient number of samples are typically tested to ensure statistical validity and representativeness of the product. The focus is on demonstrating "substantial equivalence" of the new device's mechanical properties to the predicate, rather than clinical performance on a "test set" of patient data.
Data Provenance: The data is derived from bench testing (laboratory studies) of the physical implant components, not from patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

This is not applicable as the "ground truth" for a mechanical implant is adherence to specified material and mechanical performance standards, not expert consensus on medical images or diagnoses. The "experts" involved would be engineers/technicians conducting the tests and interpreting the results against the ASTM standards.

4. Adjudication Method for the Test Set

Not applicable for mechanical bench testing. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involve human interpretation of data where consensus is needed to establish a "ground truth" (e.g., reading medical images).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interpret medical images. This document pertains to a physical surgical implant, not an AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

Not Applicable. This is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on adherence to standardized engineering specifications and mechanical performance criteria (e.g., ASTM F543, ASTM F1717) and the established material properties of the chosen medical-grade alloys (ASTM F136, ASTM F1537). This is a physical and engineering ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient data. The ultimate 'ground truth' for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI device, so there is no "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI model, this question is irrelevant to the device described.

Summary

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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

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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)

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 DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Angela BatkerLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 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:

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Intended Use of the Device:

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.

Regulation Number and Section

§ 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.