(187 days)
Not Found
No
The summary describes a mechanical pedicle fixation system with no mention of AI/ML components, image processing, or data sets for training/testing.
Yes
The device is described as providing "immobilization and stabilization of spinal segments as an adjunct to fusion" for various spinal conditions, which are treatments for diseases or injuries, making it a therapeutic device.
No
The device is a pedicle fixation system intended for immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is therapeutic (fixation), not diagnostic.
No
The device description explicitly lists physical components like screws, rods, and hooks, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Mini-OSTEO Pedicle Fixation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The components listed (screws, rods, hooks, connectors) are all physical implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The Mini-OSTEO system does not perform any such analysis of biological specimens.
Therefore, the Mini-OSTEO Pedicle Fixation System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine 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 of the thoracic, lumbar, and/or sacral spine: degenerative disc disease (DDD) 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., scollosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
Product codes
NKB, KWP
Device Description
The Mini-OSTEO Pedicle Fixation System consists of the following non-sterile, single-use components: monoaxial screws, polyaxial screws, rods, pedicle bars, laminar and transverse hooks, connectors, and a pedicle locking component for connectors. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.
Materials
- Unalloyed Titanium conforming to ASTM F67 .
- Ti6Al4V Alloy conforming to ASTM F136
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle fixation of the spine (thoracic, lumbar, and/or sacral spine)
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)
NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- Evaluation of the Test Methods For Spinal Implant as per ASTM F1717
- Torsion, Driving Torque, Insertion and Remotion Torques, and Axial Pullout as per ASTM F543
- Evaluation of the Interconnection Mechanisms And Subassemblies Used In Spinal Arthrodesis Implants as per ASTM F 1798
The results of this testing indicate that the Mini-OSTEO Pedicle Fixation System are equivalent to predicate devices.
CLINICAL TEST SUMMARY
No clinical studies were performed
NON-CLINICAL CONCLUSIONS
OSTEOMED Implantes considers the the Mini-OSTEO Pedicle Fixation System to be equivalent to the predicate device listed above. This conclusion is based upon the devices similarities in principles of operation, technology, materials and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 21, 2023
OSTEOMED Indústria e Comércio de Implantes LTDA Fernando Neto Official Correspondent Washington Luis Route, 172 km - Anhanguera's Garden Rio Claro, São Paulo 13500-970 Brazil
Re: K231443
Trade/Device Name: Mini-OSTEO Pedicle Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: November 1, 2023 Received: November 1, 2023
Dear Fernando Neto:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231443
Device Name Mini-OSTEO Pedicle Fixation System
Indications for Use (Describe)
The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine 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 of the thoracic, lumbar, and/or sacral spine: degenerative disc disease (DDD) 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., scollosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
Brazil
GENERAL INFORMATION
| Date Prepared:
Trade name:
Common name:
Classification:
Product Codes:
Device Panel:
CFR section: | November 09th, 2022
Mini-OSTEO Pedicle Fixation System
Pedicle Screw Spinal System
Thoracolumbosacral Pedicle Screw System, Class II
NKB, KWP
Orthopedic
21 CFR 888.3070
21 CFR 888.3050 |
|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
Devices: | K162494 - CD Horizon® Spinal System, Mecatronic, Inc.
K122226 - Revere® Stabilization System, Globus Medical, Inc.
K190636 - Reline 4.5-5.0 System, NuVasive |
| Submitter: | Fernando Argenton Neto (Responsible Engineer)
regulatorios@osteomedimplantes.com |
| Contact: | Davis Machado Larrubia (Project's Manager)
davis.projetos@osteomedimplantes.com |
| Applicant: | OSTEOMED Industria e Comércio de Implantes LTDA.
Washington Luis Route, 172 km - Anhanguera's Garden
Zip Code:13500-970 - + 55 19 3522-3064 - Rio Claro - São Paulo |
DEVICE DESCRIPTION
The Mini-OSTEO Pedicle Fixation System consists of the following non-sterile, single-use components: monoaxial screws, polyaxial screws, rods, pedicle bars, laminar and transverse hooks, connectors, and a pedicle locking component for connectors. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.
Materials
- Unalloyed Titanium conforming to ASTM F67 .
- . Ti6Al4V Alloy conforming to ASTM F136
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The Mini-OSTEO Pedicle Fixation System are substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|-------------|---------------------------------------------|------------------------|-----------------|-------------------|
| K222229 | Advanced LumFix Spinal Fixation
System | CG Bio Co.,
Ltd. | NKB | Primary |
| K223096 | Dark Star Deformity Pedicle Screw
System | Republic
Spine, LLC | NKB,
KWP | Additional |
4
INDICATIONS FOR USE
The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine 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/or sacral spine: degenerative disc disease (DDD) 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, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- . Evaluation of the Test Methods For Spinal Implant as per ASTM F1717
- Torsion, Driving Torque, Insertion and Remotion Torques, and Axial Pullout as per ASTM F543
- Evaluation of the Interconnection Mechanisms And Subassemblies Used In Spinal ● Arthrodesis Implants as per ASTM F 1798
The results of this testing indicate that the Mini-OSTEO Pedicle Fixation System are equivalent to predicate devices.
CLINICAL TEST SUMMARY
No clinical studies were performed
NON-CLINICAL CONCLUSIONS
OSTEOMED Implantes considers the the Mini-OSTEO Pedicle Fixation System to be equivalent to the predicate device listed above. This conclusion is based upon the devices similarities in principles of operation, technology, materials and indications for use.