(26 days)
Not Found
No
The 510(k) summary describes a mechanical implant (pedicle screw system components) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used as an adjunct to spinal fusion for various medical conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a disease or injury.
No
The device is a pedicle screw system, which is an implant used for spinal fusion. Its purpose is to structurally support the spine during the fusion process, not to diagnose a condition.
No
The device description explicitly states it is a system of physical components (Fixed Length Cross Connectors) manufactured from titanium alloy, which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fixation as an adjunct to fusion. This is a therapeutic and structural device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is described as a pedicle screw system and cross connectors made of titanium alloy. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, the Apelo™ Pedicle Screw System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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); tumor; pseudarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, NKB
Device Description
The subject of this submission is the design of Fixed Length Cross Connectors for the Apelo™ Pedicle Screw System and additional smaller sizes, 20mm through and including 42mm. The Atlas Spine Fixed Length Cross Connectors will provide surgeons additional smaller sizes from which to choose based on the patients' anatomies. The Atlas Spine Fixed Length Cross Connectors will be manufactured from medical grade titanium alloy, Ti-6AI-4V (ELI), in accordance with ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle
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)
Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA's regulation of medical devices, the Atlas Spine Fixed Length Cross Connectors is substantially equivalent in the intended use, design, materials and functional characteristics compared to the predicate devices.
The subject device similarities include:
- The same indications for use
- The same operating principle
- The same raw materials
- Similar manufacturing environments
- The same packaging configurations
- The same sterilization process
- Implanted using the same surgical techniques and similar equipment types
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072426, K110842, K041592, K081414
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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i12759
Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Pedicle Screw System ンドレート > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >
510(k) SUMMARY
| Manufacturer: | Atlas Spine, Inc. |
|---|---|
| Address: | 1555 Jupiter Park Drive, Suite #4 |
| Jupiter, FL 33458 | |
| Telephone: | 561-741-1108 |
| Fax: | 561-741-1870 |
| Establishment Reg. No. | 3003855635 |
| Official Correspondent: | Thomas G. Smith |
| Title: | Manager, Regulatory Affairs & Quality Assurance |
| Telephone: | 561-354-4318 |
| Date Prepared: | September 19, 2011 |
| Device Classification | |
| Name: | Spinal pedicle fixation orthosis |
| Trade/Proprietary Name: | Apelo™ Pedicle Screw System |
| Common Name: | Pedicle screw spinal system |
| Classification: | Class III per 21 CFR §888.3070 |
| Product Code: | MNI, MNH, and NKB |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Apelo™ Pedicle Screw System |
| Atlas Spine, Inc. | |
| K072426, K110842 | |
| Coral™ Spinal System |
Theken Spine, LLC K041592, K081414
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Image /page/0/Picture/7 description: The image shows a black and white illustration of what appears to be a chain. The chain is composed of several circular or oval links connected in a series. The links are thick and dark, and they are arranged in a horizontal line. The chain is slightly curved, and it has a rough, hand-drawn appearance. The background is plain white.
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K112759 Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Pedicle Screw System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intended Use:
The Apelo" Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fosion for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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); tumor; pseudarthrosis; and failed previous fusion.
.
Device Description:
The subject of this submission is the design of Fixed Length Cross Connectors for the Apelo" Pedicle Screw System and additional smaller sizes, 20mm through and including 42mm. The Atlas Spine Fixed Length Cross Connectors will provide surgeons additional smaller sizes from which to choose based on the patients' anatomies. The Atlas Spine Fixed Length Cross Connectors will be manufactured from medical grade titanium alloy, Ti-6AI-4V (ELI), in accordance with ASTM F-136.
Equivalence to Marketed Product
Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA's regulation of medical devices, the Atlas Spine Fixed Length Cross Connectors is substantially equivalent in the intended use, design, materials and functional characteristics compared to the predicate devices.
The subject device similarities include:
- · The same indications for use
- · The same operating principle
- · The same raw materials
- · Similar manufacturing environments
- · The same packaging configurations
- · The same sterilization process
- · Implanted using the same surgical techniques and similar equipment types
Conclusion
Provided documentation demonstrates that the Atlas Spine Fixed Length Cross Connectors is substantially equivalent to the aforementioned predicate devices. This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Atlas Spine, Inc. % Mr. Thomas Smith Manager, Regulatory Affairs & Quality Assurance 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458
OCT 1 8 2011
Re: K112759
Trade/Device Name: Apelo Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: September 19, 2011 Received: September 22, 2011
Dear Mr. Smith:
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 contractly and warranties. We remind you; however, that device labeling must be truthful and not mislery]
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
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Page 2 - Mr. Thomas Smith
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 yours,
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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Indications for Use
510(k) Number (if known):
Device Name: Apelo™ Pedicle Screw System
Indications for Use:
The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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); tumor; pseudarthrosis; and failed previous fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Posted November 13, 2003)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K112759