The APEX Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 neurological impairment, fracture, dislocation, scoliosis, 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 having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The APEX Spine System is also a hook and sacraliliac 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), tumor, and previous failed fusion (pseudo-arthrosis).

Device Description

The added Ø5.50mm and Ø6.0mm CoCr Spinal Rods are identical to the existing devices of the previously cleared APEX Spine System with recards to indications for use and function. The Ø5.50mm and Ø6.0mm CoCr Rods are available in various lengths and are designed for use with the previously cleared titanium alloy components of the APEX Spine System which can accept a Ø5.50mm and/or Ø6.0mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The Ø5.50mm and Ø6.0mm CoCr Rods will be labelled as components of the APEX Spine System.

AI/ML Overview

The provided text describes a 510(k) submission for the APEX Spine System with CoCr Rods. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating the performance of an AI model or diagnostic device against acceptance criteria.

Therefore, the input does not contain the information necessary to complete the requested table and details regarding acceptance criteria and studies proving device performance in the context of AI or diagnostic accuracy studies. The document explicitly states:

"No clinical studies were performed."
The non-clinical tests were ASTM standards for mechanical properties of spinal implants.

Given this, I cannot fill out the requested table or provide information about:

Acceptance criteria and reported device performance (in terms of diagnostic accuracy/AI performance): Not applicable, as this is a mechanical spinal implant, not an AI or diagnostic device. Performance is typically assessed through mechanical testing and substantial equivalence, not diagnostic metrics.
Sample size for the test set and data provenance: No clinical/diagnostic test set was used. Mechanical testing involved specific constructs.
Number of experts used to establish ground truth: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable in the context of diagnostic performance.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

The document is purely about the regulatory clearance of a physical medical device (spinal rods) based on material specifications, intended use, and mechanical testing, demonstrating substantial equivalence to predicates.

Summary

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K10 2488 Page 1 of 3

510(k) Summary for the APEX Spine System w/ CoCr Rods

DEC 1 0 2010

In accordance with 21 CFR 807.92 of the Federal Code of Requlations This special 510(k) is submitted to add Ø5.5mm and Ø6.0mm CoCr Spinal Rods to our existing APEX Spine System.

Date Prepared: 11/16/2010

1. Submitter: SpineCraft, LLC 2215 Enterprise Drive Westchester, IL 60154 USA Tel: 1 708-531-9700. Fax: 1708- 531-9702

Contact Person:

Ami Akallal-Asaad Director of Requiatory Affairs. SpineCraft, LLC a.asaad@spinecraft.com

1. Trade name: APEX Spine System w/ CoCr Rods Common Name: Pedicle screw system Classification Name: Pedicle screw spinal system per MNI 888.3070 Pedicle screw spinal system per MNH 888.3070 Spinal interlaminal fixation orthosis per KWP 888.3050 Spinal intervertebral body fixation orthosis per KWQ 888.3050 Class II

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

APEX Spine System w/ Ti Rods (K062513 / K092825) / SpineCraft .
Beacon / Revere Ti & CoCr Rods (K092610 / K100788) / Globus .
Range / Denali Ti & CoCr Rods (K070229 / K080792) / K2M .

Description of the device: 4.

Materials:

CoCr28Mo6 per ASTM F1537 and ISO 5832-12 Ti-6Al-4V 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

5. Substantial equivalence claimed to predicate devices

APEX Spine System w/ CoCr Rods is substantially equivalent to the APEX w/ Ti Rod (K062513 / K092825), Beacon / Revere w/ Ti & CoCr Rods (K092610 / K100788) and Range / Denali w/ Ti & CoCr Rods (K070229 / K080792) in terms of intended use, design, materials used, mechanical

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K102488 Page 2 of 3

safety and performances, The table below compares the features and characteristics of the APEX w/ CoCr Rods to these predicate devices.

DeviceNameItems	APEX w/ CoCrRods	APEX w/ Ti Rod	BeaconRevere w/ Ti &CoCr Rods	Range / Denaliw/ Ti & CoCrRods
Sponsor	SpineCraft	SpineCraft	Globus	K2M
510(k)Number	Currentsubmission	K062513 K092825	K092610 K100788	K070229 K080792
Rod material	Ø5.5mm &Ø6.0mm - CoCr	Ø5.5mm &Ø6.0mm - Ti-6Al-4V alloy	Ø5.5mm &Ø6.35mm Ti-6Al-4V alloy & CoCr	Ti-6Al-4V alloy &CoCr
Screw loading	Top	Top	Top	Top
Screwmaterial	Titanium Ti-6Al-4V alloy, perASTM F136	Titanium Ti-6Al-4V alloy, perASTM F136	Titanium Ti-6Al-4V alloy, perASTM F136	Titanium Ti-6Al-4V alloy, perASTM F136
Polyaxialscrew	Has polyaxialscrews	Has polyaxialscrews	Has polyaxialscrews	Has polyaxialscrews
Monoaxialscrew	Has monoaxialscrews	Has monoaxialscrews	Has monoaxialscrews	Has monoaxialscrews
HasCrosslinks?	Yes	Yes	Yes	Yes
Hooks	Laminar andPedicle Hooks	Laminar andPedicle Hooks	Has hooks	Has hooks
Has Washer?	Polyaxial ScrewWashers	Polyaxial ScrewWashers	Polyaxial ScrewWashers	Polyaxial ScrewWashers
Sterility	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital	Non-sterile,steam sterilizedat hospital

6. Intended 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudo-arthrosis).

The APEX Spine System is also a hook and sacral/iliac 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

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and/or dislocation), spinal stenosis, deformities (scoliosis and/or kyphosis), turnor, and previous failed fusion (pseudo-arthrosis).

7. Non-clinical Test Summary:

The following tests were conducted:

ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectorny . Model"
ASTM F1798 (2008), "Standard Guide for Evaluating the Static and Fatigue Properties of . Interconnection Mechanisms and Subassemblies used in Spinal Arthrodesis Implants."

8. Clinical Test Summary

No clinical studies were performed

9. Conclusions Nonclinical and Clinical

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

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

DEC 1 0 2010

Re: K102488

Trade/Device Name: APEX Spine System w/CoCr Rods Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWO Dated: November 18, 2010 Received: November 23, 2010

Dear Ami 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 .- 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 (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/CDRH/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 vours.

A. B. R.

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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Page 1 of 1

A. Indication for Use Statement

DEC 1 0 2010

510(k) Number (if known): K102488 Device Name: APEX Spine System

Indication for Use:

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)

Sign

(Division Sign .. 11) Division of Surval, Orthopedic, and Restorative Devices

K162488 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.