(84 days)
Not Found
No
The document describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on mechanical testing.
Yes
The device is described as a spinal fixation system intended to provide "immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities." This clearly indicates its use in treating medical conditions or supporting the structure or function of the body, which aligns with the definition of a therapeutic device.
No
The NuVasive Armada Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of physical components like screws, rods, and connectors, which are hardware. The 510(k) is for a modification to a component used in the assembly of these physical parts.
Based on the provided text, 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 description clearly states that the NuVasive Armada, Precept, and SpheRx Spinal Systems are composed of implants like screws, rods, and connectors that are surgically implanted into the spine.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device is a spinal implant system used in surgery, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The NuVasive Polyaxial Spinal Screws (Precept, Armada, and SpheRx Systems) are 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 posterior thoracic, lumbar, and sacral spine:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor and/or
- Failed previous fusion (pseudoarthrosis)
The NuVasive Polyaxial Spinal Screws are also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Polyaxial Spinal Screws are also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal stenosis
- Spondylolisthesis
- Spinal deformities
- Fracture
- Pseudoarthosis
- Tumor resection and/or
- Failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, MNI, MNH, KWQ
Device Description
The NuVasive Polyaxial Screws are part of the following NuVasive systems: Precept (K102514), Armada (K092287), and SpheRx PPS (K090981) that consist of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. 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 the modification to a component used in the assembly of tulip to screw shanks of polyaxial screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior thoracic, lumbar, and sacral spine
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 NuVasive Polyaxial Spinal Screws are substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic flexion-extension moment testing per ASTM F1798
- Tulip pull-off
- Tension-torsion
The results of these studies showed that the subject NuVasive Polyaxial Spinal Screws meet or exceed 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): 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
§ 888.3070 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
Image /page/0/Picture/0 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 a bold, sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The logo is simple and modern, and the tagline suggests that Nuvasive is a company that is focused on innovation.
510(k) Summary
A.
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:
AUG 2 4 2012
Submitted by: Elias Ketchum Senior Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4588 Fax: (858) 320-4688
Date Prepared: August 21, 2012
B. Device Name
| Trade or Proprietary Name: NuVasive® Polyaxial Spinal Screws | |
|---|---|
| Common or Usual Name: | Pedicle Screw System |
| Classification Name: | Pedicle Screw Spinal System, Spinal Interlaminal Fixation |
| Orthosis, Spinal Intervertebral Body Fixation orthosis | |
| Device Class: | Class III |
| Classification: | §888.3050, §888.3060, §888.3070 |
| Product Code: | NKB, KWP, MNI, MNH, KWQ |
C. Predicate Devices
The subject NuVasive Polyaxial Spinal Screws are substantially equivalent to the Precept™ (K102514), Armada® (K092287), and SpheRx® PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive.
. D. Device Description
The NuVasive Polyaxial Screws are part of the following NuVasive systems: Precept (K102514), Armada (K092287), and SpheRx PPS (K090981) that consist of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. 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 the modification to a component used in the assembly of tulip to screw shanks of polyaxial screws.
1
Image /page/1/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized graphic element 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. The overall design is clean and modern.
E. Intended Use
NuVasive® Armada® Spinal System
When used as a pedicle screw fixation system, the NuVasive Armada Spinal 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 the posterior thoracic, lumbar, and sacral spine:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
-
- Fracture
- Dislocation 4.
- స్ Scoliosis
-
- Kyphosis
-
- Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The NuVasive Armada Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Armada Spinal System is also intended for the following indications:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Spinal stenosis
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthosis
-
- Tumor resection and/or
-
- Failed previous fusion
2
Image /page/2/Picture/1 description: The image contains the logo for Nuvasive. The logo consists of a stylized graphic element on the left, followed by the word "NUVASIVE" in capital letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.
NuVasive® Precept™ Spinal System
When used as a pedicle screw fixation system, the NuVasive Precept Spinal 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 the posterior thoracic, lumbar, and sacral spine:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
-
- Fracture
-
- Dislocation
-
- Scoliosis
-
- Kyphosis
-
- Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The NuVasive Precept Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Spinal stenosis
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthosis
-
- Tumor resection and/or
-
- Failed previous fusion
3
Image /page/3/Picture/0 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 the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.
SpheRx® PPS System
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal 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 the posterior thoracic, lumbar, and sacral spine:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
-
- Fracture
-
- Dislocation
-
- Scoliosis
- Kyphosis 6.
- Spinal tumor and/or 7.
- Failed previous fusion (pseudoarthrosis) 8.
The NuVasive SoheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Spinal stenosis
- Spondylolisthesis 3.
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthosis
-
- Tumor resection and/or
-
- Failed previous fusion
F. Technological Characteristics
As was established in this submission, the subject NuVasive Polyaxial Spinal Screws are 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.
4
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive® Polyaxial Spinal Screws are substantially equivalent to other predicate devices. The following testing was performed:
- . Static and dynamic flexion-extension moment testing per ASTM F1798
- . Tulip pull-off
- Tension-torsion .
The results of these studies showed that the subject NuVasive Polyaxial Spinal Screws meet or exceed 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 NuVasive Polyaxial Spinal Screws have been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
5
Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 4 2012
NuVasive, Incorporated % Mr. Elias Ketchum Senior Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K121619
Trade/Device Name: NuVasive Polyaxial Spinal Screws (Precept, Armada, and SpheRx Systems)
Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH, KWQ Dated: July 26, 2012 Received: July 27, 2012
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 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
6
Page 2 - Mr. Elias Ketchum
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/CDRH0ffices/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 Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K121619
NuVasive® SpheRx® PPS System Device Name:____
Indications For Use:
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal 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 the posterior thoracic, lumbar, and sacral spine:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
-
- Fracture
-
- Dislocation
-
- Scollosis
-
- Kyphosis
- . 7. Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal stenosis 2.
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
Prescription Use
-
- Pseudoarthosis
-
- Tumor resection and/or
X
-
- Failed previous fusion
(Part 21 CFR 801 Subpart D)
- Failed previous fusion
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
K121614 510(k) Number_
Page 1 of 3
8
Indications for Use
510(k) Number (if known): K121619
NuVasive® Armada® Spinal System Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
When used as a pedicle screw fixation system, the NuVasive Armada Spinal 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 the posterior thoracic, lumbar, and sacral spine:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
-
- Fracture
-
- Dislocation
- Scoliosis 5.
-
- Kyphosis
-
- Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The NuVasive Armada Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Armada Spinal System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the ﮩﮯ disc confirmed by patient history and radiographic studies)
- Spinal stenosis 2.
-
- Spondylolisthesis
- Spinal deformities ব :
-
- Fracture
-
- Pseudoarthosis
- Tumor resection and/or 7.
Failed previous fusion 8.
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 of Surgical, Orthopedic, and Restorative Devices
K121619 510(k) Number_
Page 2 of 3
9
Indications for Use
510(k) Number (if known): K121619
Device Name:
Indications For Use:
When used as a pedicle screw fixation system, the NuVasive Precept Spinal 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 the posterior thoracic, lumbar, and sacral spine:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
-
- Fracture
- Dislocation 4.
-
- Scoliosis
-
- Kyphosis
-
- Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The NuVasive Precept Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Spinal stenosis
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthosis
- Tumor resection and/or 7.
- 8 Failed previous fusion
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
KIZI619 510(k) Number_
Page 3 of 3