(43 days)
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an osteosynthesis system intended for immobilization and stabilization of spinal segments, which is a supportive and corrective function, not one that directly treats a disease or condition to restore health.
No
The device is a spinal osteosynthesis system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, which is a treatment, not a diagnostic process.
No
The device description explicitly states it consists of physical components like screws and rods made of titanium alloy and Cobalt Chrome alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant system (screws and rods) used to stabilize the spine. It is implanted in the body, not used to test specimens from the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or laboratory procedures, which are hallmarks of IVDs.
This device is a surgical implant intended for orthopedic use.
N/A
Intended Use / Indications for Use
ROMEO posterior osteosynthesis 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, 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).
Product codes
MNI, MNH, KWP
Device Description
The modifications to ROMEO posterior osteosynthesis system (K081165 & K093170) manufactured by SPINEART consist of addition of 4.0 and 8.0 mm in diameter polyaxial screws made of titanium alloy, addition of Cobalt Chrome alloy rods, and extension of length range for other screw diameter and rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and 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
Mechanical testing including static axial compression, static torsion and dynamic axial compression tests have been performed according to ASTM F1717-09. Results demonstrate that additional components perform as safely and effectively as their predicate devices.
Key Metrics
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.
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510(k) SUMMARY
As required by section 807.92
JUL 2 8 2010
| Submitter | SPINEART
International Center Cointrin 20 route de pré-bois CP1813
1215 GENEVA 15
SWITZERLAND |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality
Phone : +41 22 799 40 25
Fax : +41 22 799 40 26
Mail : fpennesi@spineart.ch
Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)
idrubaix@nordnet.fr |
| Trade Name | ROMEO posterior osteosynthesis system |
| SPECIAL 510k | Modification to ROMEO posterior osteosynthesis system
(Extension of range of products) |
| CFR section | 888.3070 |
| Classification Name | Pedicle screw spinal system |
| Class | II |
| Product Code | MNI orthosis, spinal pedicle fixation |
| Subsequent product codes | MNH orthosis, spondylolisthesis spinal fixation
KWP Spinal interlaminal fixation orthosis |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | ELLIPSE posterior osteosynthesis system (K081165) and
ROMEO posterior osteosynthesis system (K093170) manufactured by SPINEART |
| Description | The modifications to ROMEO posterior osteosynthesis system (K081165 & K093170) manufactured by SPINEART consist of addition of 4.0 and 8.0 mm in diameter polyaxial screws made of titanium alloy, addition of Cobalt Chrome alloy rods, and extension of length range for other screw diameter and rods. |
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101678
Tage 25
| Intended Use | ROMEO posterior osteosynthesis 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, 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). |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | ROMEO posterior osteosynthesis additional components
conforms to special control established for Pedicle screw
spinal system and to « Spinal System 510(k)s - Guidance
for Industry and FDA Staff Document » issued on: May 3,
2004.
Mechanical testing including static axial compression, static
torsion and dynamic axial compression tests have been
performed according to ASTM F1717-09. Results
demonstrate that additional components perform as safely
and effectively as their predicate devices. |
| Substantial equivalence | ROMEO posterior osteosynthesis system additional
components are substantially equivalent to their predicate
device in terms of intended use, material, design,
mechanical properties and function.
Non clinical performance testing according to special control
demonstrate that additional components are as safe, as
effective, and performs as safely and effectively as their
predicate devices. |
Revised July 16, 2010
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comments of the comments of
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the wings and body. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 8 2010
Spineart % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de pre-bois CP1813 1215 Geneva 15, Switzerland
Re: K101678
Trade/Device Name: ROMEO Posterior Osteosynthesis System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: July 19, 2010 Received: July 20, 2010
Dear Mr. Pennesi:
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.
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Page 2 - Mr. Franck Pennesi
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.
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,
Валал Омеша
Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
1161678
K101678 510(k) Number (if known): Device Name: ROMEO posterior osteosynthesis system Indications for Use:
JUL 2 8 2010
ROMEO posterior osteosynthesis 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, 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 (pseudarthrosis).
Prescription Use > (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Ci Division of Surgical, Orthopedic, Restorative Devices
510(k) Number.