The APEX Spine 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. Iumbar, 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 (pseudoarthrosis).

The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain 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, and/or lordosis), turnor, pseudoarthrosis, and failed prvious fusion in skeletally mature patients . Levels of fixation are for the thoracic. lumbar and sacral spine.

Device Description

The purpose of this submission is to add cannulated screws to the APEX Spine System and add indications for use of the APEX Spine System in a posterior percutaneous approach and product code NKB. The APEX Spine System Cannulated Screws have exactly the same geometry of the APEX screws with the addition of a cannulation. The screws are available in a variety of diameters and lengths and can be used with the components of the previously cleared APEX Spine System.

Materials: Titanium alloy per ASTM F136

Function: The APEX Spine System is indicated for 1)non-cervical spinal fixation devices intended for posterior, non-pedicle fixation, 2)for non-cervical pedicle screw fixation and 3)hook fixation systems of the non-cervical spine, 4)for degenerative disc disease.

AI/ML Overview

The APEX Spine System is a pedicle screw spinal system. The submission (K110906) addresses the addition of cannulated screws to the system and new indications for use in a posterior percutaneous approach.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static Compression Bending - Static Torsion - Dynamic Compression Bending	Met: Results were "equal or higher than the predicate systems" for all tests (ASTM F1717-09).
Material Composition: - Titanium alloy per ASTM F136	Met: The device utilizes Titanium alloy per ASTM F136.
Biocompatibility: (Implicitly covered by substantial equivalence to predicates)	Met: Substantially equivalent to predicate devices with established biocompatibility.
Sterility: - Non-sterile, steam sterilized at hospital	Met: Device is non-sterile and intended for steam sterilization at the hospital.

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

Sample Size: Not explicitly stated for specific tests. The document refers to "testing" and "results," implying a sufficient number of samples were tested to generate comparative data.
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by the manufacturer or a contracted testing facility, following ASTM standards. This is a retrospective analysis in the context of device design and comparison to predicates.

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

Not applicable. This submission focuses on the mechanical and material equivalence of a spinal implant system to predicate devices, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical sense.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission does not involve human readers or clinical interpretation that would require an adjudication method. The "adjudication" here is the comparison of mechanical test results against established predicate device performance and ASTM standards.

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

No. This type of study is not applicable to a spinal implant system focused on mechanical performance and material composition.

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

Not applicable. This device is a physical spinal implant, not an AI algorithm.

7. The Type of Ground Truth Used

Engineering/Performance Standards: The "ground truth" used for testing was primarily based on:
- ASTM F1717-09: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
- Predicate Device Performance: The performance of previously cleared spinal systems (e.g., APEX Spine System (K062513), Viper Spine System (K090648), Polaris Spinal System (K103393), Synthes Pangea System (K052123)).
- Material Specifications: ASTM F136 for Titanium alloy.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this kinesiologic and material equivalence submission for a physical medical device. The device's design is based on established engineering principles and prior device knowledge, not a data-driven training process.

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

Not applicable. As there is no training set, this question is not relevant. The "ground truth" in development of such a device is rooted in biomechanical principles, material science, and the established safety and effectiveness of predicate devices.

Summary of the Study Proving Acceptance Criteria:

The study summarized in K110906 is a non-clinical bench testing study designed to demonstrate the substantial equivalence of the modified APEX Spine System (with added cannulated screws and percutaneous approach indication) to its predicate devices.

Study Name: Non-clinical Test Summary
Study Type: Bench Testing, Mechanical Performance Comparison.
Methodology:
- Tests were conducted according to ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
- Specific tests included: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.
- The "acceptance criteria" here were that the results of these tests for the new device configuration should be "equal or higher" than those of the predicate devices.
Results: The new device configuration for the APEX Spine System with cannulated pedicle screws met these performance criteria, with results reported as "equal or higher than the predicate systems."
Conclusion: Based on these non-clinical tests, the manufacturer concluded that the APEX Spine System with the added cannulated pedicle screws is substantially equivalent to the predicate devices in terms of intended use, design, materials, performance, and function. No clinical studies were performed for this submission, as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

Summary

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K110 906

page 1 of 3

510(K) Summary for the APEX Spine System

JUL 26 2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the APEX Spine System with the added Cannulated Pedicle Screws

Date Prepared: 6/14/2011

1. Submitter:	Contact Person:
SpineCraft, LLC	Ami Akallal-Asaad
2215 Enterprise Drive	Director of Regulatory Affairs.
Westchester, IL 60154 USA	SpineCraft, LLC
Tel: 1 708-531-9700.	a.asaad@spinecraft.com
Fax: 1708- 531-9702

2. Trade name:	APEX Spine System Cannulated Screws
Common Name:	Pedicle screw system
Classification Name:	Pedicle screw spinal system per MNI 888.3070
	Pedicle screw spinal system per MNH 888.3070
	Pedicle screw spinal system per NKB 888.3070
	Spinal interlaminal fixation orthosis per KWP 888.3050
	Spinal intervertebral body fixation orthosis per KWQ 888.3060
Device Class:	Class III
Classification Panel:	Orthopedics

3. Predicate or legally marketed devices which are substantially equivalent:

APEX Spine System (K062513 / K092825 / K102488) / SpineCraft .
Viper Spine System (K090648 / K102701) / DePuy Spine .
Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine / EBI. L.P. .
Synthes Pangea System (K052123) / Synthes Spine .

4. Description of the device:

Materials:

Titanium alloy per ASTM F136

Function:

The APEX Spine System is indicated for 1)non-cervical spinal fixation devices intended for posterior, non-pedicle fixation, 2)for non-cervical pedicle screw fixation and 3)hook fixation systems of the non-cervical spine, 4)for degenerative disc disease.

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5. Substantial equivalence claimed to predicate devices

APEX Spine System with the added cannulated pedicle screws is substantially equivalent to the APEX Spine System (K062513 / K092825 / K102488), Viper Spine System (K090648 / K102701), Polaris Spinal System (K103393 / K100409 / K100438) and Synthes Pangea System (K052123) in terms of intended use, design, materials used, mechanical safety and performances,. The table below compares the features and characteristics of the APEX Spine System with the added Cannulated Pedicle Screws to these predicate devices.

DeviceNameItems	APEX SpineSystem	APEX SpineSystem	Viper SpineSystem	Polaris SpinalSystem	Synthes PangeaSystem
Sponsor	SpineCraft	SpineCraft	DePuy	BIOMET Spine /EBI, L.P.	Synthes Spine
510(k) Number	Currentsubmission	K062513 /K092825 /K102488	K090648 /K102701	K103393 /K100409 /K100438	K052123
Forpercutaneoususe	Yes	No	Yes	Yes	Yes
Rod material	Titanium alloyper ASTM F136& CoCr	Titanium alloyper ASTM F136& CoCr	Titanium alloy &CoCr	Titanium alloyper ASTM F136	Pure Titaniumper ASTM F67and Titaniumalloy per ASTMF-1295
Rod geometry	Straight & curved	Straight & curved	Straight & curved	Straight & curved	Straight
Screw loading	Top	Top	Top	Top	Top
Screw material	Titanium alloyper ASTM F136& CoCr	Titanium alloyper ASTM F136& CoCr	Titanium alloy &CoCr	Titanium alloyper ASTM F136	Pure Titaniumper ASTM F67and Titaniumalloy per ASTMF-1295
Monoaxialscrew diameter	Yes	Yes	Yes	Yes	Yes
Polyaxial screwdiameter	Yes	Yes	Yes	Yes	Yes
Cannulatedscrews	Yes	No	Yes	Yes	Yes
Crosslinks	Yes	Yes	Yes	Yes	Yes
Hooks?	Laminar andPedicle Hooks	Laminar andPedicle Hooks	Yes	Yes
Sterility	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital

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6. Intended Use:

7. Non-clinical Test Summary:

The following tests were conducted:

ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate svstems.

8. Clinical Test Summary

No clinical studies were performed

9. Conclusions Nonclinical and Clinical ·

The APEX Spine System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SpineCraft. LLC % Ms. Ami Akallal-Asaad Director of Regulatory Affairs 2215 Enterprise Drive Westchester, Illinois 60154

JUL 2 6 2011

Re: K110906

Trade/Device Name: APEX Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWO, KWP Dated: June 14, 2011 Received: June 17, 2011

Dear Ms. Akallal-Asaad:

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

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Page 2 - Ms. Ami Akallal-Asaad

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Eric Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. Indication for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: APEX Spine System

Indication for Use:

The APEX Spine System is intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System is also a sacralfiliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), turnor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI10906 510(k) Number_

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.