(50 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The purpose of the submission is for sterile packaging.
Yes
The device is intended to provide temporary stabilization, aid in the repair of bone fractures, and correct spinal deformities, which are all therapeutic functions.
No
The device is a temporary implant used for stabilization during spinal surgery, aiding in bone fusion and fracture repair. It is a physical device that functions as a bone anchor and does not perform diagnostic functions.
No
The device description clearly states it is comprised of physical implants (bands, clamps, and set screws) made of materials like PET and titanium alloy, intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "temporary implant for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like bands, clamps, and set screws made from specific materials, designed to attach to spinal rods. This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text contains no mention of analyzing biological specimens or providing diagnostic information.
Therefore, the NILE Alternative Fixation Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis:
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.
Product codes
OWI
Device Description
The NILE Alternative Fixation Spinal System implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods. The band is manufactured from polyethylene terephthalate (PET) and the clamps and set screws are made from titanium alloy in accordance with ASTM F136. Once the bands are secured the stainless steel tips are detached and are not intended to be implanted.
Function: The NILE Alternative Fixation Spinal System is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.
The purpose of this submission is to allow for sterile packaging of the NILE clamps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
patients 8 years of age and older, adult
Intended User / Care Setting
orthopedic surgery
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)
The NILE Alternative Fixation Spinal System implants were previously tested and compared to predicate devices. The NILE Alternative Fixation system implants performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity. No modifications were made to the implants and therefore additional testing was not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18. 2016
K2M, Incorporated Ms. Nancy Giezen Manager Regulatory Affairs 751 Miller Drive SE Leesburg, Virginia 20175
Re: K160208
Trade/Device Name: Nile Alternative Fixation Spinal System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: February 26, 2016 Received: February 29, 2016
Dear Ms. Giezen:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160208
Device Name
NILE Alternative Fixation Spinal System
Indications for Use (Describe)
The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY NILE Alternative Fixation Spinal System
Submitter
K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 571-919-2000 Date Prepared: 2/26/2016
Classification
NILE Alternative Fixation Spinal System Trade Name: Common Name: Bone Fixation Cerclage Class II Regulatory Class:
Classification Name(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI)
Predicate Device(s)
Primary Predicate: K2M NILE Alternative Fixation Spinal System (K143350) Secondary Predicates: K2M Range/ Denali/ Mesa Spinal System (K141873) K2M Cascadia Interbody System (K150481)
Device Description
The NILE Alternative Fixation Spinal System implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods. The band is manufactured from polyethylene terephthalate (PET) and the clamps and set screws are made from titanium alloy in accordance with ASTM F136. Once the bands are secured the stainless steel tips are detached and are not intended to be implanted.
Function: The NILE Alternative Fixation Spinal System is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.
The purpose of this submission is to allow for sterile packaging of the NILE clamps.
4
Indications For Use
The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis:
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.
Technological Comparison to Predicate(s)
The NILE Alternative Fixation Spinal System implants were compared to predicate devices and the design features, materials and intended uses were found to be substantially equivalent to these systems.
Non-clinical Performance Evaluation
The NILE Alternative Fixation Spinal System implants were previously tested and compared to predicate devices. The NILE Alternative Fixation system implants performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity. No modifications were made to the implants and therefore additional testing was not deemed necessary.
Conclusion
There are no significant differences between the NILE Alternative Fixation Spinal System implants and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and performance.