(166 days)
Not Found
No
The device description and performance studies focus on mechanical properties and design modifications of a physical implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
Explanation: The device is intended for use as an aid in cervical spinal fusion and temporary stabilization of the anterior spine in patients with various medical conditions, indicating its therapeutic purpose in treating a disease or condition.
No
This device is an Anterior Cervical Plating (ACP) System, intended for use in spinal fusion and temporary stabilization of the anterior spine. It is an implantable medical device used in surgical procedures, not for diagnostic purposes.
No
The device description clearly states it is an Anterior Cervical Plating System, which includes physical implants (plates and screws) and associated instrumentation. This is a hardware-based medical device.
Based on the provided text, the Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "use as an aid in cervical spinal fusion" and "for temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used in vivo (within the body) to support the spine.
- Device Description: The description details plates and screws made of titanium alloy, designed to be implanted into bone. This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Aviator® ACP System is a surgical implant used to physically stabilize the spine.
N/A
Intended Use / Indications for Use
The Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Trauma (including fractures) Tumors Deformities or curvatures (including kyphosis, lordosis, or scoliosis) Pseudoarthrosis Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy Spondylolisthesis Spinal Stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The purpose of this 510(k) is to summarize the design modifications that have been implemented to the Aviator® Anterior Cervical Plating (ACP) System previously FDA cleared via K083562. No new implant reference numbers/part numbers were created. Additionally, there were no changes to the previously FDA cleared indications, intended uses, mode of operation, scientific technology, materials of construction, or to the performance of the device.
The Aviator® Anterior Cervical system are one-, two-, three-, and four-level plate configurations ranging in lengths from 12 mm to 22 mm for the one-level plates, 24mm to 46mm for the two-level plates, 39 mm to 69 mm for the three-level plates, and 56 mm to 96 mm for the four-level plates. All of the plate levels incorporate a spring bar blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0 mm and 4.35 mm diameters in lengths of 10 mm – 20 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V).
The associated instrumentation (such as awls, punch awls, screwdrivers, handles, drill guides and drill bits, plate bender, storage and transport trays/container, and fixation pins) are Class I / 510(k) exempt devices under 21 CFR §888.4540.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spinal, cervical spine at levels C2-T1
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)
Cadaveric and bench design verification testing was conducted on the modified devices to assess impact. All previous ASTM testing submitted with K083562 were repeated for the modified device:
ASTM 1717-09, “Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model” for Static Compression Bending, Dynamic (Fatigue) Compression Bending, and Static Torsion Tests ASTM 1798-97, “Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants for Static Cantilever Bending There were no new failure modes, identification of new risks, or establishment of a new worst-case construct as a result of the design changes. The non-clinical test results were comparable to the predicate design and demonstrated that implemented modifications did not adversely impact device performance, and the safety and effectiveness profile of the device.
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.
K083562 - Stryker Spine Aviator® Anterior Cervical Plating (ACP) System, K062310, K040261 – Stryker Spine Reflex® Hybrid ACP System K000536, K000742 – Synthes Spine Cervical Spine Locking Plate System
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Stryker Spine Ms. Soraya King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K142237
Trade/Device Name: Aviator® Anterior Cervical Plating (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 29, 2014 Received: December 30, 2014
Dear Ms. King:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Soraya King
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/Resourcesfor You/Industry/default.htm. 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 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 vours.
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) K142237
Device Name
Aviator® Anterior Cervical Plating (ACP) System
Indications for Use (Describe)
The Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Aviator® Anterior Cervical Plating System is intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
| • Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) |
|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- · Trauma (including fractures)
- Tumors
- · Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- · Pseudoarthrosis
- · Failed previous fusion
- · Decompression of the spinal cord following total or partial cervical vertebrectomy
- · Spondylolisthesis
- · Spinal Stenosis
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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2 Pearl Court Allendale, NJ 07401 t: 866 45 SPINE www.stryker.com
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Spine
510(k) #K142237– Design Modifications to the Stryker Spine Aviator® Anterior Cervical Plate (ACP) System
| 510(k) Summary: Aviator® Anterior Cervical Plating (ACP) System | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Soraya King, MS |
| Regulatory Affairs Specialist | |
| Phone: 201-760-8296 | |
| Fax: 201-962-4296 | |
| Email: Soraya.King@Stryker.com | |
| Date Prepared | 21 January 2015 |
| Trade Name | Aviator® Anterior Cervical Plating (ACP) System |
| Common Name | Appliance, Fixation, Spinal Intervertebral Body |
| Proposed Class | Class II |
| Classification | |
| Name and | |
| Number | Spinal Intervertebral Body Fixation Orthosis |
| 21 CFR §888.3060 | |
| Product Code | KWQ |
| Predicate Device | K083562 - Stryker Spine Aviator® Anterior Cervical Plating (ACP) System, (Primary Predicate Device) K062310, K040261 – Stryker Spine Reflex® Hybrid ACP System K000536, K000742 – Synthes Spine Cervical Spine Locking Plate System |
| Device | |
| Description | The purpose of this 510(k) is to summarize the design modifications that have been |
| implemented to the Aviator® Anterior Cervical Plating (ACP) System previously | |
| FDA cleared via K083562. No new implant reference numbers/part numbers were | |
| created. Additionally, there were no changes to the previously FDA cleared | |
| indications, intended uses, mode of operation, scientific technology, materials of | |
| construction, or to the performance of the device. |
The Aviator® Anterior Cervical system are one-, two-, three-, and four-level plate
configurations ranging in lengths from 12 mm to 22 mm for the one-level plates,
24mm to 46mm for the two-level plates, 39 mm to 69 mm for the three-level plates,
and 56 mm to 96 mm for the four-level plates. All of the plate levels incorporate a
spring bar blocking mechanism to aid in prevention of bone screw back-out. The
bone screws are provided with either fixed or variable angles available in self-
tapping or self-drilling designs. The variable angle bone screws allow the screw to
be placed into bone at various degrees of angulation, while the fixed bone screws are
inserted at a defined angle. Any combination of bone screws can be used to secure |
| 510(k) Summary: Aviator® Anterior Cervical Plating (ACP) System | |
| | the cervical plate. The bone screws are offered in 4.0 mm and 4.35 mm diameters in lengths of 10 mm – 20 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V). |
| | The associated instrumentation (such as awls, punch awls, screwdrivers, handles, drill guides and drill bits, plate bender, storage and transport trays/container, and fixation pins) are Class I / 510(k) exempt devices under 21 CFR §888.4540. |
| Indications for Use | The Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. |
| | The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: |
| | Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Trauma (including fractures) Tumors Deformities or curvatures (including kyphosis, lordosis, or scoliosis) Pseudoarthrosis Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy Spondylolisthesis Spinal Stenosis |
| Summary of the
Technological
Characteristics | The design modifications did not alter the fundamental scientific technology or change/introduce an energy source. The modified devices retained previously FDA cleared indications/intended use and mode of operation as presented in 510(k) #K083562. |
| | The Aviator® plates utilize the same anti-backout spring bar mechanism as the predicate design. The spring bar continues to automatically close when the screw has completely advanced through the screw slots on the plates. The design feature that allows the surgeon to rotate the blocker for additional visual and tactile feedback to ensure that the spring bars is in the secured position has been maintained. There were no changes in the materials of construction. The implants continue to be manufactured from surgical grade implantable titanium alloy. |
| 510(k) Summary: Aviator® Anterior Cervical Plating (ACP) System | |
| The implemented design modifications did not raise new questions of safety or efficacy. | |
| Summary of the
Performance
Data | Cadaveric and bench design verification testing was conducted on the modified devices to assess impact. All previous ASTM testing submitted with K083562 were repeated for the modified device:
ASTM 1717-09, “Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model” for Static Compression Bending, Dynamic (Fatigue) Compression Bending, and Static Torsion Tests ASTM 1798-97, “Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants for Static Cantilever Bending There were no new failure modes, identification of new risks, or establishment of a new worst-case construct as a result of the design changes. The non-clinical test results were comparable to the predicate design and demonstrated that implemented modifications did not adversely impact device performance, and the safety and effectiveness profile of the device. |
Revised 510(k) Summary
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510(k) #K142237– Design Modifications to the Stryker Spine Aviator® Anterior Cervical Plate (ACP) System
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510(k) #K142237– Design Modifications to the Stryker Spine Aviator® Anterior Cervical Plate (ACP) System
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510(k) #K142237- Design Modifications to the Stryker Spine Aviator® Anterior Cervical Plate (ACP) System
| 510(k) Summary: Aviator® Anterior Cervical Plating (ACP) System | ||
|---|---|---|
| Feature | Aviator® ACP System (K083562) | Modified Aviator® ACP System |
| (Letter to File Changes) | ||
| Locking mechanism | Spring-loaded Spring Bar is provided pre-assembled to the plate | Spring-Loaded Spring Bar is provided pre-assembled to the plate |
| Anti-backout | ||
| mechanism | Opens with screw | Opens with screw |
| Integrated with plate | ||
| using slot to house | ||
| mechanism | Integrated with plate using slot to | |
| house mechanism | Integrated with plate using slot to house mechanism | |
| Thickness of anti- | ||
| backout mechanism | .3-.4 mm | .3-.4 mm |
| Material | Ti 6AL-4V | Ti 6AL-4V |
| Number of screw holes | ||
| mechanism supports | 1 screw hole | 1 screw hole |
| Basic Plate Shape | "Dogbone" design with graft viewing | |
| windows | "Dogbone" design with graft viewing windows | |
| Plate Levels | One-, Two-, Three-, and Four- level | |
| configurations | One-, Two-, Three-, and Four- level configurations | |
| Plate Lengths | One-level: 12-22mm | |
| Two-level: 24-46mm | ||
| Three-level: 39-69mm | ||
| Four-level: 56-96mm | One-level: 12-22mm | |
| Two-level: 24-46mm | ||
| Three-level: 39-69mm | ||
| Four-level: 56-96mm | ||
| Plate Width | 17.4mm | 17.4mm |
| Plate Profile | 2.5mm thickness, smooth surface (no | |
| protrusions) | 2.5mm thickness, smooth surface (no protrusions) | |
| Plate Curvature | Sagittal – 190mm (1 & 2 level) & | |
| 390mm (3 & 4 level) | ||
| Axial – 25mm | Sagittal - 190mm (1 & 2 level) & 390mm (3 & 4 level) | |
| Axial - 25mm | ||
| Plate Screw-Hole | ||
| Geometry | Middle screw holes - round End | |
| screw holes - elongated | Middle screw holes - round End screw holes - elongated | |
| Bone Screw Diameter | 4.0mm and 4.35mm | 4.0mm and 4.35mm |
| 510(k) Summary: Aviator® Anterior Cervical Plating (ACP) System | ||
| Mechanical | ||
| Performance | Tested as per ASTM 1717 and ASTM 1798 | Tested as per ASTM 1717 and ASTM 1798 |
| Conclusions | The modified device has identical indications, technological characteristics, and | |
| principles of operation as the predicate design. The non-clinical test data demonstrated | ||
| that the implemented design changes did not impact the performance of the device, the | ||
| function of the device, or how the device is utilized in comparison to the predicate | ||
| design. There were no new risks identified associated with the implemented changes. | ||
| The modifications have demonstrated to be substantially equivalent to the previously | ||
| cleared design and predicate systems presented in 510(k) #K083562. |
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