(118 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.
No.
The RENOIR Posterior Cervical Fixation System is explicitly described as a spinal fixation system, intended to provide "stabilization as an adjunct to fusion" following reduction of fractures/dislocations or trauma in the spine, and to "promote fusion." This indicates its role as an implant for structural support and to aid in the fusion process, rather than a device for therapeutic treatment of conditions. Its function is mechanical stabilization and support for bony fusion.
No
The RENOIR Posterior Cervical Fixation System is a surgical implant designed to provide stabilization and promote fusion in the spine. It is not used to diagnose medical conditions but rather to treat them.
No
The device description clearly states it is a "multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, semi-reduction poly screws, reduction poly screws, straight rods, curved rods, set screws, hooks and set screws," all made of titanium alloy. This indicates a physical implant system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The RENOIR Posterior Cervical Fixation System is a surgical implant made of titanium alloy. It is designed to be physically implanted into the spine to provide stabilization.
- Intended Use: The intended use is to provide stabilization as an adjunct to fusion in the cervical/upper thoracic spine for various conditions like DDD, spondylolisthesis, fractures, etc. This is a therapeutic and structural function, not a diagnostic one based on analyzing specimens.
The information provided clearly describes a surgical implant used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RENOIR Posterior Cervical Fixation System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
MNI, KWP
Device Description
The RENOIR Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, semi-reduction poly screws, reduction poly screws, straight rods, curved rods, set screws, hooks and set screws.
Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical/upper thoracic (C1-T3) spine, T1-T3 (for pedicle screws)
Indicated Patient Age Range
Not Found
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)
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a Worst-case, Screw construct. The mechanical test results demonstrated that the RENOIR Posterior Cervical Fixation System performs as well as the predicate device.
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.
K031985, K050979, K060152, K003780, K103414, K120879
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
AUG 9 2012
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| 1. Submitter: | Accel SPINE |
|---|---|
| 14850 Quorum Dr. Suite 220 | |
| Dallas, TX 75254 | |
| Contact Person: | Daniel Chon |
| Phone. 800.713.9489 | |
| Fax.888.831.4892 | |
| Email.dchon@accelspine.com | |
| Date prepared: | April 4, 2012 |
2. Device Identification
| Proprietary Name | RENOIR Posterior Cervical Fixation System |
|---|---|
| Common Name | Pedicle Screw Spinal System |
| Product Code | MNI,KWP |
| Classification Name | Pedicle Screw Spinal System (888.3070) |
| Spinal Interlaminal Fixation Orthosis | |
| (21CFR888.3050) | |
| Regulatory Class | Class II |
Predicate or legally marketed devices which are substantially equivalent 3.
- Spinal Concept Inc./ Nex-Link spinal Fixation (K031985) .
- Aesculp Inc. / S4 Spinal Fixation (K050979, K060152) .
- Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System . (K003780)
- L&K BIOMED Co.,Ltd. / LEXUS Cervical Fixation System (K103414, K120879)
1
4. Description of the Device
The RENOIR Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinalfixation system which consists of polyaxial screws, semi-reduction poly screws, reduction poly screws, straight rods, curved rods, set screws, hooks and set screws.
Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.
5. Intended use
The RENOIR Posterior Cervical Fixation System is indicated for the following:
- . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- . Spondylolisthesis
- . Spinal stenosis
- . Fracture/dislocation
- . Failed previous fusion
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.
The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
- Comparison of the technology characteristics of the device to predicate and legally marketed devices
The RENOIR Posterior Cervical Fixation System is considered substantially equivalent to other legally marketed devices. They are similar in design, material and indications for use and are expected to be equivalent in safety and effectiveness.
2
7. Non-Clinical Testing
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a Worst-case, Screw construct. The mechanical test results demonstrated that the RENOIR Posterior Cervical Fixation System performs as well as the predicate device.
8. Conclusion
The RENOIR Posterior Cervical Fixation System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.
3
Image /page/3/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 9 2012
Accel Spine % Mr. Daniel Chon 14850 Quorom Drive, Suite 220 Dallas, Texas 75254
Re: K121136
Trade/Device Name: RENOIR Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: April 03, 2012 Received: May 21, 2012
Dear Mr. Chon: ·
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
4
Page 2 - Mr. Daniel Chon
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.
Yours,
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure :
5
Indications for Use
510(k) Number (121136
Device Name : RENOIR Posterior Cervical Fixation System
Indications for Use :
The RENOIR Posterior Cervical Fixation System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- ◆ Spondylolisthesis
- Spinal stenosis ●
- . Fracture/dislocation
- . Failed previous fusion
- . Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft orallograft following the reduction of fractures/dislocations or trauma in the spine.
Hooks and rods are also intended to provide stabilization to promote fusionfollowing reduction offracture/dislocation or trauma in the cervical/upperthoracic (C1-T3)spine.
The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CPRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-( . . ) Division of Surperel. Orthopedic, and Restorative تحمال S
K12 1136 510(k) Number.
Renoir Posterior Cervical Fixation System