(193 days)
Not Found
No
The summary describes a mechanical spinal fusion system made of standard medical-grade materials and tested using standard mechanical testing protocols. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is indicated for spinal fusion procedures to treat degenerative disc disease, which involves alleviating pain and restoring function.
No
Explanation: The CoRoent No-Profile System is described as a standalone system indicated for spinal fusion procedures, specifically an implant used for degenerative disc disease. Its purpose is therapeutic fixation, not diagnosis. The performance studies mentioned focus on mechanical properties and substantial equivalence to other fusion devices, not diagnostic accuracy.
No
The device description explicitly states it is manufactured from PEEK-Optima LT1, titanium alloy, and Nitinol SE508 alloy, and includes implants and bone screws. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a system for spinal fusion procedures in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and components of a surgical implant (PEEK-Optima LT1, titanium alloy, Nitinol SE508 alloy, bone screws). This is consistent with a medical device used in surgery, not a diagnostic kit or instrument.
- Performance Studies: The performance studies listed are mechanical and structural tests (compression, torsion, expulsion, subsidence, wear debris, screw pullout/push-out/push-through, separation). These are relevant to the safety and efficacy of a surgical implant, not the analytical or clinical performance of a diagnostic test.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CoRoent No-Profile System is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.
Product codes
MAX, OVD
Device Description
The NuVasive CoRoent No-Profile Standalone System is manufactured from PEEK-Optima LT1, titanium alloy, and Nitinol SE508 alloy. The implants are available in a variety of sizes to suite the individual pathology and anatomical conditions of the patient. The CoRoent No-Profile Standalone System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2 to S1)
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)
Nonclinical testing was performed to demonstrate that the subject CoRoent No-Profile System is substantially equivalent to other predicate devices. The following testing was performed:
- Static & Dynamic Axial Compression testing per ASTM F2077-03 .
- Static & Dynamic Torsion testing per ASTM F2077-03 ●
- Expulsion testing per Draft standard, work item Z8423Z .
- Subsidence testing per ASTM F2267-04 .
- Wear Debris per ASTM F2077 & ASTM F17877 .
- Axial Screw Pullout per ASTM F543 .
- Screw Push-out Testing .
- Screw Push-through Testing t
- Static Separation Testing .
The results of these studies, as well as the descriptive information presented, demonstrates that the subject CoRoent No-Profile System is substantially equivalent to the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100043, K102090, K041617, K073109, K091301, K082252
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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MAR 1 3 2012
Image /page/0/Picture/2 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.
Special 510(k) Premarket Notification CoRoent No-Profile System
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
A. Submitted by:
Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615
Date Prepared: September 1, 2011
B. Device Name
| Trade or Proprietary Name: | NuVasive CoRoent® No-Profile System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CRF §888.3080 |
| Product Code: | MAX, OVD |
C. Predicate Devices
The subject NuVasive CoRoent No-Profile System is substantially equivalent to the following device:
| 510(k) Number | Product Name |
|---|---|
| K100043 | NuVasive CoRoent XLR Standalone System |
| K102090 | SpineSmith Cynch Spinal System – Visualif Interbody Fusion |
| Implant System | |
| K041617, | |
| K073109 | SurgiCraft STALIFTM TT Intervertebral Body Fusion System |
| K091301 | Life Spine® Stand-Alone Spacer System (Dyna-Link®) |
| K082252 | Globus Medical Independence® Spacer |
D. Device Description
The NuVasive CoRoent No-Profile Standalone System is manufactured from PEEK-Optima LT1, titanium alloy, and Nitinol SE508 alloy. The implants are available in a variety of sizes to suite the individual pathology and anatomical conditions of the patient. The CoRoent No-Profile Standalone System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation".
E. Intended Use
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.
F. Technological Characteristics
As was established in this submission, the subject CoRoent No-Profile System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject CoRoent No-Profile System is substantially equivalent to other predicate devices. The following testing was performed:
- Static & Dynamic Axial Compression testing per ASTM F2077-03 .
- Static & Dynamic Torsion testing per ASTM F2077-03 ●
- Expulsion testing per Draft standard, work item Z8423Z .
- Subsidence testing per ASTM F2267-04 .
- Wear Debris per ASTM F2077 & ASTM F17877 .
- Axial Screw Pullout per ASTM F543 .
- Screw Push-out Testing .
- Screw Push-through Testing t
- Static Separation Testing .
The results of these studies, as well as the descriptive information presented, demonstrates that the subject CoRoent No-Profile System is substantially equivalent to the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject CoRoent No-Profile System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Inc. % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
MAR 1 3 2012
Re: Ki12561
Trade/Device Name: NuVasive CoRoent No-Profile System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: February 10, 2012 Received: February 13, 2012
Dear Ms. Bruschi:
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
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Page 2 - Ms. Sheila Bruschi
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Grice-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 100.97). 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,
Sincerely yours,
Mark N. Molkerson
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
510(k) Number (if known): K112561
Device Name:
Indications For Use:
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K 11256 ( 510(k) Number_