(89 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as providing "temporary internal fixation and stabilization during bone graft healing and/or fusion mass development" as an "adjunct to fusion in the treatment of various spinal instabilities," which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a spinal fixation system intended for surgical correction of spinal deformities and stabilization during bone graft healing. Its purpose is to provide mechanical support, not to diagnose conditions.
No
The device description explicitly states it consists of "nonsterile, single use implants," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical implant for spinal fixation to aid in bone fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description clearly states it's a "spinal fixation system" consisting of "implants." This aligns with a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used during surgery.
N/A
Intended Use / Indications for Use
It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis), The ROC Lumbar Plating System is indicated for placement in L3 - S1.
Product codes
MNI, MNH, KWP
Device Description
The ROC Lumbar Plating System is a spinal fixation system that consisting of a variety of nonsterile, single use implants that facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle fixation, L3 - 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)
Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff. This testing documented both static and fatigue performance characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation. As a result of this testing, the ROC Lumbar Plating System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Alphatec Spine. The logo features a stylized lowercase Greek letter alpha above the company name. The text "Alphatec Spine" is in a bold, italicized font. The logo is in black and white.
510(k) SUMMARY January 2009
Carozz8
Submitter: Alphatec Spine, Inc. APR 2 9 2009 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6739 (760) 431-0289 Fax: Official Contact: Karla Schaffner, Regulatory Affairs Submissions Specialist Trade/Model Name: ROC Lumbar Plating System Pedicle Screw Spinal System Common Name: Classification Regulation: MNI - 888.3070 - Orthosis, Spinal Pedicle Fixation MNH - 888.3070 - Orthosis, Spondylolisthesis Spinal Fixation
Substantial Equivalence:
The ROC Lumbar Plating System is substantially equivalent in intended use and function to the following predicate devices.
Device Description:
The ROC Lumbar Plating System is a spinal fixation system that consisting of a variety of nonsterile, single use implants that facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
Intended Use
It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis), The ROC Lumbar Plating System is indicated for placement in L3 - S1.
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Image /page/1/Picture/0 description: The image shows the logo for Alphatec Spine. The logo consists of a stylized lowercase Greek letter alpha above the words "Alphatec Spine" in a bold, sans-serif font. The alpha symbol is in a cursive style, and the words "Alphatec Spine" are stacked vertically below it.
510(k) Summary Alphatec Spine, Inc. ROC Lumbar Plating System
Ko90228
Technological Characteristics Comparison:
The ROC Lumbar Plating System is equivalent to the referenced devices in that it is intended to be used to provide temporary internal lumbar fixation and stabilization during bone graft healing and/or fusion mass development. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.
Material composition is identical to numerous other Alphatec Spine products that have been cleared via the 510(k) process.
Nonclinical Performance Data:
Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff. This testing documented both static and fatigue performance characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation. As a result of this testing, the ROC Lumbar Plating System is substantially equivalent to the predicate devices.
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Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2009
Alphatec Spine, Inc % Karla Schaffner 5818 El Camino Real Carlsbad, CA 92008
Re: K090228
Trade/Device Name: ROC Lumbar Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: January 29, 2009 Received: January 30, 2009
Dear Ms. Schaffner:
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.
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 (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.
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Page 2 – Ms. Karla Schaffner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ROC Lumbar Plating System
Image /page/4/Picture/1 description: The image shows the logo for Alphatec Spine. The logo consists of the Greek letter alpha in a cursive font above the words "Alphatec Spine". The text is in a bold, sans-serif font.
510(k) Number TBD
Alphatec Spine
Section 4 Indications for Use Statement
Kogo227 510(k) Number (if known): FBD
Device Name: ROC Lumbar Plating System
Indications for Use:
It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - S1.
Prescription Use J X (Per 21 CFR 801.109)
OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oarlare Brienm
Division of General, Restorative, and Neurological Devices
510(k) Number K090228
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