(79 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or any technology related to AI/ML.
Yes
The device is intended to treat and provide immobilization for various spinal conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an osteosynthesis system intended to provide immobilization of spinal segments as an adjunct to fusion, which is a therapeutic rather than diagnostic function.
No
The device description explicitly lists hardware components such as screws, rods, and connectors, and mentions surgical instruments. There is no mention of software as a component of the device.
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 system designed to provide mechanical support and stabilization to the spine. It is used in the body during surgery.
- Device Description: The device components are screws, rods, and connectors made of Titanium or CoCr, which are typical materials for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases, monitor conditions, or screen for health issues. This device is a surgical implant used to treat structural problems in the spine.
N/A
Intended Use / Indications for Use
Romeo® posterior osteosynthesis 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; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, Romeo® posterior osteosynthesis system is intended for the following indications: 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 failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
Device Description
The Romeo posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors. The Romeo screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. Romeo components are delivered sterile (gamma sterilization) in a dedicated packaging or not sterile upon request. The Romeo posterior fixation system is supplied with a set of surgical instruments.
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
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 non-clinical tests were conducted: Torsion test for the set-screw according to in-house protocol; Axial Push Down and Axial Torsion in subassembly according to ASTM F1798 for the connectors. Results demonstrate comparable mechanical properties to the predicate devices.
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
SPINEART Mr. Franck Pennesi Director of Industry & Ouality International Center Cointrin 20 route de pré-bois. CP 1813 1215 Geneva 15 Switzerland
Re: K151695
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: MNH, MNI Dated: June 22, 2015 Received: June 23, 2015
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.
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
1
Page 2 - Mr. Franck Pennesi
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K151695
Device Name
Romeo® posterior osteosynthesis system
Indications for Use (Describe)
Romeo® posterior osteosynthesis 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; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, Romeo® posterior osteosynthesis system is intended for the following indications: 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 failed previous fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Commercial Use (If marked, SEE Additional Instructions)
Any Other use covered by 37 CFR
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
TRADITIONAL 510k
ROMEO® Posterior Osteosynthesis System
510(k) SUMMARY
| Submitted by | SPINEART |
|---|---|
| International Center Cointrin | |
| 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Contacts | Franck PENNESI Director of Industry & Quality |
| Phone : +41 22 570 1246 Fax : +41 22 799 40 26 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) | |
| Mail : idrubaix@nordnet.fr | |
| Date Prepared | August 17th 2015 |
| Common Name | Pedicle screw spinal system |
| Trade Name | Romeo® posterior osteosynthesis system |
| Classification Name | Pedicle screw spinal system |
| Class | II |
| Product Code | MNH, MNI |
| CFR section | 888.3070 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary predicate: Ellipse posterior osteosynthesis system (K081165) manufactured by |
| Spineart Other predicate: Romeo® posterior osteosynthesis system (K111127, K141835) | |
| manufactured by Spineart | |
| 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). | |
| When used as a posterior, non-cervical, non-pedicle screw fixation system, Romeo® | |
| posterior osteosynthesis system is intended for the following indications: 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, kyphosis, and/or lordosis); tumor; | |
| pseudoarthrosis; and failed previous fusion |
4
| Description of the device | The Romeo posterior fixation system comprises polyaxial screws, monoaxial screws,
spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and
various connectors. The Romeo screws come in various lengths (from 25 to 90 mm) and
diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient
anatomies. Romeo components are delivered sterile (gamma sterilization) in a dedicated
packaging or not sterile upon request. The Romeo posterior fixation system is supplied
with a set of surgical instruments. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The purpose of this 510(k) submission is to obtain clearance for a Romeo Setscrew with a
modified hexalobe imprint, a Romeo Parallel Rod Connector and a T Rod Connector.
These Romeo components are made of Titanium alloy Ti6Al4V ELI conforming to ISO
5832.3 and ASTM F136 and are fully compatible with components of the existing Romeo posterior fixation system. |
| Discussion of Testing | The following non-clinical tests were conducted: Torsion test for the set-screw according
to in-house protocol; Axial Push Down and Axial Torsion in subassembly according to
ASTM F1798 for the connectors. Results demonstrate comparable mechanical properties
to the predicate devices. |
| Conclusion | Design comparisons and non-clinical performance testing demonstrate that the added
devices (Setscrew, T connector and Parallel Rod Connector O/O) are substantially
equivalent to their predicate devices (K081165, K111127 and K141835) in terms of
intended use, material, design, mechanical properties and function. |