(70 days)
Not Found
No
The device description and performance studies focus on mechanical properties and structural integrity, with no mention of AI/ML or related concepts.
Yes.
The device is used as an "adjunct to fusion" for treating various spinal instabilities, indicating a direct therapeutic purpose.
No
The device is a surgical plate system used to stabilize the spine, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of physical components like plates, screws, bolts, and locking nuts, which are hardware. The 510(k) is for a line extension of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The NuVasive Traverse Plate System is described as a system of plates, screws, bolts, and locking nuts used for spinal fusion. These are physical implants used within the body during surgery.
- Intended Use: The intended use clearly states it's for treating spinal instability through surgical approaches. This involves direct intervention on the patient's anatomy, not testing samples outside the body.
The information provided describes a surgical implant system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The NuVasive Traverse Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of:
-
- Fracture (including dislocation and subluxation)
-
- Tumor
-
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Scoliosis
-
- Kyphosis
-
- Lordosis
-
- Spinal stenosis
-
- Failed previous spine surgery
Product codes (comma separated list FDA assigned to the subject device)
KWQ, KWO
Device Description
The Traverse Plate System consists of a variety of plates, screws, bolts, and locking nuts. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is for a line extension to the Traverse Plate System for an additional plate configuration and bolt size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) spine
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)
Nonclinical testing was performed to demonstrate that the subject Traverse Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717 .
The results of these studies showed that the subject Traverse Plate 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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for "NUVASIVE Creative Spine Technology". The logo has a stylized graphic to the left of the company name. The words "Creative Spine Technology" are in a smaller font below the company name.
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:
Elias Ketchum Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4588 Fax: (858) 320-4688
Date Prepared: December 22, 2010
B. Device Name
| Trade or Proprietary Name: | NuVasive ® Traverse Plate System |
|---|---|
| Common or Usual Name: | Spinal Implants |
| Classification Name: | Spinal Intervertebral Body Fixation orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | $888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject Traverse Plate System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:
- K082070 NuVasive Traverse Plate System �
- K070273 NuVasive Lateral Plate System .
- K102514 NuVasive SpheRx II MAS Deformity Spinal System ●
Device Description D.
The Traverse Plate System consists of a variety of plates, screws, bolts, and locking nuts. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is for a line extension to the Traverse Plate System for an additional plate configuration and bolt size.
E. Intended Use
The NuVasive Traverse Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of:
-
- Fracture (including dislocation and subluxation)
-
- Tumor
MAR - 3 2011
1
Image /page/1/Picture/1 description: The image contains the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE" in all caps. Below the company name is the text "Creative Spine Technology" in a smaller font size. The logo is black and white.
-
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Scoliosis
-
- Kyphosis
-
- Lordosis
-
- Spinal stenosis
-
- Failed previous spine surgery
F. Technological Characteristics
As was established in this submission, the subject Traverse Plate 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 Traverse Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717 .
The results of these studies showed that the subject Traverse Plate 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 Traverse Plate System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
2
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 3 2011
NuVasive, Inc. % Mr. Elias Ketchum Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K103750
Trade/Device Name: NuVasive® Traverse Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: February 01, 2011 Received: February 02, 2011
Dear Mr. Ketchum:
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. Elias Ketchum
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A.S. R
for
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):
Device Name: Indications For Use:
The NuVasive Traverse Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of:
-
- Fracture (including dislocation and subluxation)
-
- Tumor
-
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Scoliosis
-
- Kyphosis
-
- Lordosis
-
- Spinal stenosis
-
- Failed previous spine surgery
Prescription Use X (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 of Surgical, Orthopedic, and Restorative Devices
K103750 510(k) Number_