(175 days)
No
The device description and performance studies focus on the mechanical properties and design of the pedicle screw system, with no mention of AI or ML.
Yes
The device is intended to treat acute and chronic instabilities or deformities of the spine and provide immobilization and stabilization, indicating a therapeutic purpose.
No
Explanation: The Renovis S 100 Pedicle Screw System is a surgical implant designed for stabilization and immobilization of the spine, not for diagnosing medical conditions. Its intended use is to provide mechanical support during healing after fusion, not to identify or characterize diseases.
No
The device description explicitly states it is comprised of polyaxial pedicle screws, rods, and crosslinks, which are hardware components.
Based on the provided information, the Renovis S 100 Pedicle Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Renovis S 100 Pedicle Screw System clearly state that it is a surgical implant used for the immobilization and stabilization of spinal segments. It is a physical device implanted within the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Renovis S 100 Pedicle Screw System falls under the category of a surgical implant or spinal fixation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Renovis S 100 Pedicle Screw 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes
MNI, MNH, KWP
Device Description
As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations
The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.
Materials:
The components are manufactured from titanium alloy (ASTM F136), CP titanium Grade 4(ASTM F67) and CoCrMo (ASTM F1537.
Function:
The S 100 Pedicle Screw System is intended to provide immobilization of spinal segments until fusion takes place.
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 vertebrae, lumbar and sacral spine (L3 to sacrum)
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
Summary of Nonclincal Tests: The following tests were conducted:
- Testing per ASTM F1717 .
- Testing per ASTM F1798 .
- Component dissociate testing .
The results of this testing was compared to a predicate system, with the results being equal or higher than the predicate system.
Clinical Test Summary: No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
K042673, K082032, K000536, K000236, K884263
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
510(k) Summary for the S 100 Pedicle Screw System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the S 100 Pedicle Screw System
DEC - 7 2010
Date Prepared: November 8, 2010
- Submitter: 1. Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374
- Contact Person: 2. Anthony DeBenedictis
- S 100 Pedicle Screw System Trade name: 2. orthosis, pedicle screw system Common Name: orthosis, spondylolisthesis spinal fixation/ MNH/ 888.3070 Classification Name: orthosis, spinal pedicle fixation/ MNI/ 888.3070 Class II
- Predicate or legally marketed devices which are substantially equivalent: 3.
ZODIAC™ Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Sequioa - K082032 (Abbott Spine) Moss Miami - K000536 (DePuy Synergy VLS - K000236 (DePuy) Rogozinski K884263 - (Smith & Nephew)
Description of the device: 4.
As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations
The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.
Materials:
The components are manufactured from titanium alloy (ASTM F136), CP titanium Grade 4(ASTM F67) and CoCrMo (ASTM F1537.
Function:
The S 100 Pedicle Screw System is intended to provide immobilization of spinal segments until fusion takes place.
Substantial equivalence claimed to predicate devices: งที่
Stan Country System is substantially equivalent to the ZODIAC™ Polyaxial Spinal Fixation in terms of intended use, design, materials used, mechanical safety and performances. The table below terms of intended book associeristics of the S 100 Pedicle Screw System to this predicate device. The eompares the received and and the Sequioa Screw - K082032 (Abbott Spine) in terms of assembly and the 5 100 Feach Serew is shiller to the Synergy VLS – open K000236 (DePuy) and the Rogozinski K884263 -(Smith & Nephew) in terms of strength.
$$\underbrace{\mathfrak{Z}^{\mathsf{h}^{\mathsf{h}}\mid\mathsf{A}^{\mathsf{h}}}}_{\mathsf{h}}$$
1
| Device
| Name | Renovis S 100 Pedicle Screw System | ZODIAC™ Polyaxial Spinal Fixation |
|---|---|---|
| Items | ||
| Sponsor | Renovis Surgical Technologies | Alphatec Spine Co. |
| 510(k) Number | -- | K042673 |
| Device | ||
| Classification | ||
| Name | orthosis, spinal pedicle fixation | |
| orthosis, spondylolisthesis spinal | ||
| fixation | ||
| spinal interlaminal fixation orthosis | orthosis, spinal pedicle fixation | |
| orthosis, spondylolisthesis spinal | ||
| fixation | ||
| spinal interlaminal fixation orthosis | ||
| Product Code | MNI, MNH, KWP | MNI, MNH, KWP |
| Indications for | ||
| Use | Per MNI, MNH, KWP | Per MNI, MNH, KWP |
| Material | Ti-6Al-4V per ASTM F136 | |
| CP Ti Grade 4 per ASTM F67 | ||
| CoCrMo per ASTM F1537 | Ti-6Al-4V per ASTM F136 | |
| CP Ti per ASTM F67 | ||
| CoCrMo per ASTM F1537 | ||
| Top loading | Yes | Yes |
| Solid | Yes | Yes |
| Cannulated | Yes | Yes |
| Monoaxial | No | Yes |
| Polyaxial | Yes | Yes |
| Crosslink | Yes | Yes |
6. Intended Use:
The Renovis S 100 Pedicle Screw 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebrae in skeletally mature patients receiving fusion by severe spondinentials (122 m) and sacral spine (13 to sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.
Summary of Nonclincal Tests: 7.
The following tests were conducted:
- Testing per ASTM F1717 .
- Testing per ASTM F1798 .
- Component dissociate testing .
The results of this testing was compared to a predicate system, with the results being equal or higher than the predicate system.
8. Clinical Test Summary:
No clinical studies were performed
Conclusions Nonclinical and Clinical: ਰੇ.
elbsions Noneinfour and Shillstone is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and method of assembly.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The seal is simple, yet recognizable, and represents the HHS's role in providing essential services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Renovis Surgical Technologies, LLC % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
DEC - 7 2010
Re: K101682
Trade/Device Name: Renovis S 100 Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: November 08, 2010 Received: November 15, 2010
Dear Mr. Webb:
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
. ".
3
Page 2 - Mr. J.D. Webb
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 (2) 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 vours.
Sincerely yours,
Mark M Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K101682 510(k) Number (if known):
DEC - 7 2010 Renovis S 100 Pedicle Screw System Device Name:
Indications for Use:
The Renovis S 100 Pedicle Screw 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 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-Division of Surgical, Orthopedic, and Restorative Device
510(k) Number
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