(65 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and MR compatibility of the physical implantable plates and screws. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for stabilizing the cervical spine, correcting deformities, and addressing instability caused by trauma, tumors, degenerative diseases, and failed surgeries, which are all therapeutic functions.
No
The device description clearly states that these are plate and screw systems made of titanium alloy used for stabilization and fixation of the cervical spine, indicating they are surgical implants, not diagnostic tools.
No
The device description explicitly details physical components made of titanium alloy, such as plates and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the stabilization and fixation of the cervical spine during surgery. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device description details physical components like plates and screws made of titanium alloy, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
Therefore, this device falls under the category of a surgical implant for spinal fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intentnent range from C2 to T1.
Indications include symptomatic cervical spondylosis, traumatic kyphosis or lordosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.
The PULSE Anterior Cervical Plate System is indication of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
SWIFT Plus: The SWIFT™ Plus Anterior Cervical Plate System is manufactured from titanium alloy and consists of segmented plates that allow up to 2mm of controlled graft settling between each of the segments. The plates are available with two to six screw hole pairs, in various lengths and two configurations, discectomy and corpectomy. The screws are available in various sizes and screw-tip geometries. A graft screw is available for use in the corpectomy plates and can be used in the SWIFT Plus system.
EAGLE Plus: The EAGLE™ Plus Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available with two to six screw hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries.
EAGLE Micro: The EAGLE Plus Micro Anterior Cervical Plate System is designed for use alone or adjacent to a previously implanted anterior cervical plate. The EAGLE Plus Micro Anterior Cervical Plate System consists of an assortment of titanium alloy single-level plates and uses EAGLE Plus screws. The anterior cervical plates are available in various lengths to accommodate varying patient anatomy.
PULSE: The DePuy PULSE™ Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to four screw-hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries, including self drilling and blunt tip to create a semi-constrained construct.
SKYLINE: The SKYLINE" Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths. The screws are available in various sizes and screwtip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.
SLIM LOC: The SLIM LOC® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available in lengths ranging from 22-111mm in configurations with 2, 3, 4, 5 or 6 pairs of screw holes. The SLIMLOC screws are available in 4.5mm in diameter and are available as self-drilling in even length sizes ranging from 10-18mm or self-tapping in even length sizes ranging from 10-26mm. Larger diameter screws (4.8mm) are available in 12, 14, and 16mm lengths.
UNIPLATE Anterior & UNIPLATE 2: The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to two segments of fixation. The screws are available in various sizes and tip geometries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2 to C7, C2 to T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical tests and analyses were conducted following standards to support MR compatibility claims. These include:
ASTM 2182-11a, "Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging"
ASTM 2213-06, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
ASTM 2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
ASTM 2119-07, "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"
The devices are determined to be MR conditional based on the results of testing completed according to FDA Guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.
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.
K072546, K070994, K080191, K112724, K052552, K103491, K013877, K042544, K082273, K100070
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
July 20, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medos International SARL % Ms. Sheree Geller Regulatory Affairs Specialist DePuv Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K171439
Trade/Device Name: EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: May 15, 2017 Received: May 16, 2017
Dear Ms. Geller:
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.
1
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 devicerelated 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 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,
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) K171439
Device Name
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLNE Anterior Cervical Plate System, SLM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
Indications for Use (Describe)
The SLIM LOC Anterior Cervical Plate System and SK YLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intentnent range from C2 to T1.
Indications include symptomatic cervical spondylosis, traumatic kyphosis or lordosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.
The PULSE Anterior Cervical Plate System is indication of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
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.
3
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510(k) SUMMARY
| Submitter: | DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767 |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Medos International, SARL
Chemin-Blanc 38
2400 Le Locle, Switzerland |
| Contact Person: | Catherine Kilshaw
Sr. Regulatory Affairs Program Lead
Telephone: (508) 880-8412
Fax: (508) 828-3797 |
| Date Prepared: | July 18, 2017 |
| Trade Name: | SWIFT Plus Anterior Cervical Plate System
EAGLE Plus Anterior Cervical Plate System
EAGLE Plus Micro Anterior Cervical Plate System
PULSE Anterior Cervical Plate System
SKYLINE Anterior Cervical Plate System
SLIM LOC Anterior Cervical Plate System
UNIPLATE Anterior Cervical Plate System
UNIPLATE 2 Anterior Cervical Plate System |
| Device Class: | II |
| Product Code: | KWQ |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation Number: | 21 CFR 888.3060 |
| Predicate Devices: | |
| EAGLE Plus Anterior Cervical Plates (K070994) | |
| EAGLE Plus Micro Anterior Cervical Plate System (K080191) | |
| PULSE Anterior Cervical Plate System (K112724) | |
| SKYLINE Anterior Cervical Plate System (K052552, K103491) | |
| SLIM LOC Anterior Cervical Plate System (K013877) | |
| UNIPLATE Anterior Cervical Plate System (K042544) | |
| UNIPLATE 2 Anterior Cervical Plate System (K082273, K100070) | |
DePuy Synthes Spine MR Compatibility Anterior Cervical Plates
5
SWIFT Plus Anterior Cervical Plate System (K072546) Primary Predicate:
Additional
Submission Purpose: Obtain clearance for MR Conditional Labeling for the systems listed.
Device Descriptions:
| SWIFT Plus | The SWIFT™ Plus Anterior Cervical Plate System is manufactured from titanium alloy and consists of segmented plates that allow up to 2mm of controlled graft settling between each of the segments. The plates are available with two to six screw hole pairs, in various lengths and two configurations, discectomy and corpectomy. The screws are available in various sizes and screw-tip geometries. A graft screw is available for use in the corpectomy plates and can be used in the SWIFT Plus system. |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- EAGLE Plus The EAGLE™ Plus Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available with two to six screw hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries.
- EAGLE Micro The EAGLE Plus Micro Anterior Cervical Plate System is designed for use alone or adjacent to a previously implanted anterior cervical plate. The EAGLE Plus Micro Anterior Cervical Plate System consists of an assortment of titanium alloy single-level plates and uses EAGLE Plus screws. The anterior cervical plates are available in various lengths to accommodate varying patient anatomy.
- PULSE The DePuy PULSE™ Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to four screw-hole pairs in various lengths. The screws are available in
6
various sizes and screw-tip geometries, including self drilling and blunt tip to create a semi-constrained construct.
- SKYLINE The SKYLINE" Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths. The screws are available in various sizes and screwtip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.
- SLIM LOC The SLIM LOC® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available in lengths ranging from 22-111mm in configurations with 2, 3, 4, 5 or 6 pairs of screw holes. The SLIMLOC screws are available in 4.5mm in diameter and are available as self-drilling in even length sizes ranging from 10-18mm or self-tapping in even length sizes ranging from 10-26mm. Larger diameter screws (4.8mm) are available in 12, 14, and 16mm lengths.
UNIPLATE Anterior
UNIPLATE 2 The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to two segments of fixation. The screws are available in various sizes and tip geometries.
Indications: The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
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The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.
The PULSE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
Material: Implant Grade Titanium Alloy (ASTM F136)
Comparison to
Predicate Device: The subject devices maintain the design characteristics of the previously cleared predicate devices. The subject devices include a claim regarding MR compatibility.
8
| Non-clinical Test
Summary: | Tests and analyses were conducted following standards referenced below
to support MR compatibility claims. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ASTM 2182-11a, "Standard Test Method for Measurement of Radio
Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging" |
| | ASTM 2213-06, "Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance
Environment" |
| | ASTM 2052-15, "Standard Test Method for Measurement of Magnetically
Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment" |
| | ASTM 2119-07, "Standard Test Method for Evaluation of MR Image
Artifacts from Passive Implants" |
| Clinical Test
Summary: | N/A |
| Conclusion: | The proposed devices are identical to the predicate devices and therefore
determined to be substantially equivalent. The devices are determined
to be MR conditional based on the results of testing completed according
to FDA Guidance document "Establishing Safety and Compatibility of
Passive Implants in the Magnetic Resonance (MR) Environment",
December 11, 2014. |