(157 days)
Not Found
No
The document describes a physical implant device and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is used to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is an interbody fusion system (implant cage and screws) used for treatment of degenerative disc disease, not for diagnosis.
No
The device description explicitly states it consists of a PEEK implant cage, titanium alloy markers and washers, and titanium alloy bone fixation screws, which are all hardware components.
Based on the provided text, 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 body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The CoRoent Small Interlock System is described as a physical implant (a cage with screws) intended for surgical insertion into the body to fuse vertebrae.
- Intended Use: The intended use is for surgical treatment of degenerative disc disease by providing structural support and promoting fusion. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly indicates this is a surgically implanted medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy Sevious markers and washers, and three (3) titanium alloy bone fixation screws. The de roos alloy conforming to ASTM F136. The implants are available in a variety of sizes The CoRoent Small Interlock System is a to accommodate anatomical conditions. standalone system intended to be used with the bone screws provided, and when used as such 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
C2-T1
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 and engineering analysis were performed to demonstrate that the subject CoRoent Small Interlock System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic compression per ASTM F2077 .
- . Subsidence per ASTM F2267
- Wear Debris per ASTM F2077 & ASTM F1877 .
The results of these studies showed that the subject CoRoent Small Interlock System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.
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.
K072415, K072981, K083389, K094042, K092521, K100043
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
§ 888.3080 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic on the left and the word "NUVASIVE" in a bold, sans-serif font on the right. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The graphic on the left appears to be an abstract representation of a curved shape.
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:
Submitted by: A.
Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615
FEB - 7 2011
Date Prepared: August 30, 2010
Device Name B.
Common or Usual Name: Classification Name: Device Class: Classification: Product Code:
Trade or Proprietary Name: NuVasive® CoRoent® Small Interlock™ System Intervertebral Body Fusion Device Intervertebral Body Fusion Device Class II 8888.3080 ODP
Predicate Devices C.
The subject CoRoent Small Interlock System is substantially equivalent to the following devices previously cleared by FDA:
- · K072415 Surgicraft Limited STALIFTM C
- · K072981- Synthes Spine Synthes Zero-P
- · K083389 Globus Medical Coalition™ Spacer
- · K094042- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device
- · K092521- SeaSpine, Inc. Zuma-CTM
- · K100043- NuVasive, Inc. CoRoent XLR Standalone System
Device Description D.
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy Sevious markers and washers, and three (3) titanium alloy bone fixation screws. The de roos alloy conforming to ASTM F136. The implants are available in a variety of sizes The CoRoent Small Interlock System is a to accommodate anatomical conditions. standalone system intended to be used with the bone screws provided, and when used as such 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 abstract shape on the left, followed by the word "NUVASIVE" in a blocky, outlined font. Below the word "NUVASIVE" is the tagline "speed of innovation" in a smaller, sans-serif font.
510(k) Premarket Notification K102547 NuVasive® CoRoent® Small Interlock™ System
E. Intended Use
The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.
F. Technological Characteristics
As was established in this submission, the subject CoRoent Small Interlock 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 and engineering analysis were performed to demonstrate that the subject CoRoent Small Interlock System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic compression per ASTM F2077 .
- . Subsidence per ASTM F2267
- Wear Debris per ASTM F2077 & ASTM F1877 .
The results of these studies showed that the subject CoRoent Small Interlock System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.
Conclusions H.
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject CoRoent Small Interlock 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 U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
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
.............................................................................................................................................................................. SEF
Re: K102547
Trade/Device Name: NuVasive® CoRoent® Small Interlock™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 10, 2011 Received: January 11, 2011
Dear Ms. Bruschi:
This letter corrects our substantially equivalent letter of February 7, 2011.
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 (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.
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
3
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,
Mark A Millberson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102547
Device Name: NuVasive® CoRoent® Small Interlock™ System
Indications For Use:
The CoRoent Small Interlock™ System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease TODD at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorauve ذنت:د:ندن
ל X102547 510(k) Number_
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