(117 days)
No
The document describes a spinal implant system and its intended use, materials, and function. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which are therapeutic interventions.
No.
The APEX Spine System is a spinal implant system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Spine System" with "cannulated screws" made of "Titanium alloy". This indicates a physical hardware device intended for surgical implantation, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The APEX Spine System is described as a system of screws, hooks, and other components intended for the immobilization and stabilization of spinal segments during fusion surgery. Its function is mechanical support and fixation within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition through testing of bodily fluids or tissues.
The device is clearly an implantable surgical device used for structural support in the spine, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
NKB, MNH, MNI, KWO, KWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; L5-S1 vertebra; L3 to S1
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)
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 systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
APEX Spine System (K062513 / K092825 / K102488), Viper Spine System (K090648 / K102701), Polaris Spinal System (K103393 / K100409 / K100438), Synthes Pangea System (K052123)
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.
0
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:
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.
1
page 2 of 3
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.
| Device
Name
Items | APEX Spine
System | APEX Spine
System | Viper Spine
System | Polaris Spinal
System | Synthes Pangea
System |
|-----------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------|
| Sponsor | SpineCraft | SpineCraft | DePuy | BIOMET Spine /
EBI, L.P. | Synthes Spine |
| 510(k) Number | Current
submission | K062513 /
K092825 /
K102488 | K090648 /
K102701 | K103393 /
K100409 /
K100438 | K052123 |
| For
percutaneous
use | Yes | No | Yes | Yes | Yes |
| Rod material | Titanium alloy
per ASTM F136
& CoCr | Titanium alloy
per ASTM F136
& CoCr | Titanium alloy &
CoCr | Titanium alloy
per ASTM F136 | Pure Titanium
per ASTM F67
and Titanium
alloy per ASTM
F-1295 |
| Rod geometry | Straight & curved | Straight & curved | Straight & curved | Straight & curved | Straight |
| Screw loading | Top | Top | Top | Top | Top |
| Screw material | Titanium alloy
per ASTM F136
& CoCr | Titanium alloy
per ASTM F136
& CoCr | Titanium alloy &
CoCr | Titanium alloy
per ASTM F136 | Pure Titanium
per ASTM F67
and Titanium
alloy per ASTM
F-1295 |
| Monoaxial
screw diameter | Yes | Yes | Yes | Yes | Yes |
| Polyaxial screw
diameter | Yes | Yes | Yes | Yes | Yes |
| Cannulated
screws | Yes | No | Yes | Yes | Yes |
| Crosslinks | Yes | Yes | Yes | Yes | Yes |
| Hooks? | Laminar and
Pedicle Hooks | Laminar and
Pedicle Hooks | Yes | Yes | |
| Sterility | Non-sterile,
steam sterilized
at hospital | Non-sterile,
steam sterilized
at hospital | Non-sterile,
steam sterilized
at hospital | Non-sterile,
steam sterilized
at hospital | Non-sterile,
steam sterilized
at hospital |
2
page 3 of 3
6. Intended Use:
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.
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.
3
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
4
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
5
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 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 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_