(113 days)
No
The description focuses on the mechanical components and intended use for spinal fusion, with no mention of AI or ML capabilities.
Yes
The device is intended for use as an aid in cervical spinal fusion for various medical indications such as degenerative disc disease, trauma, and tumors, indicating its therapeutic purpose in treating or alleviating a disease or condition.
No
Explanation: The device is a cervical plating system used for temporary stabilization and fusion of the cervical spine, not for diagnosing medical conditions.
No
The device description clearly states it is a system of physical plates and screws intended for surgical implantation, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior intervertebral screw fixation of the cervical spine at levels C2-T1" as an "aid in cervical spinal fusion." This describes a surgical implant used in vivo (within the body) to provide structural support and stabilization.
- Device Description: The description details plates and screws designed for implantation into the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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)
- Pseudarthrosis
- Failed previous fusion
- Decompression of the spinal cord following total or partial cervical vertebrectomy
- Spondylolisthesis
- Spinal stenosis
WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates and Bone Screws approved under K062310 and K040261: - Aviator plates in 1-level, 2-level, 3-level, and 4-level configurations and in lengths ranging from 12mm through 96mm - Aviator 4.0 mm and 4.35mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle selfdrilling and fixed-angle sclf-tapping). The subject system introduces various length plates that contain a new "spring bar" anti-backout mechanism similar to the existing Reflex Hybrid "locking ring" anti-backout mechanism. In addition to the new anti-backout mechanism introduced on the Aviator plate, new screws have been introduced with a modified head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062310, K040261, K000536, K000742
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 5 2009
Line Extension to the Stryker Spine Reflex® Hybrid ACP System
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Aviator Anterior Cervical Plate System
Line Extension to the Stryker Spine Reflex® Hybrid ACP System
Proprietary Name:
Aviator ACP System
Common Name:
Proposed Regulatory Class:
Anterior Cervical Plate System Class II
Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060
Device Product Code:
KWQ
Sponsor: For Information contact:
Stryker Spine Vikki O'Connor Regulatory Affairs Consultant 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8215 Fax: (201) 760-8415 Email: vikki.o'connor@stryker.com
Date Summary Prepared:
March 24, 2009
Predicate Device
Stryker Spine Reflex® Hybrid ACP System (K062310, K040261) and Synthes Spine Cervical Spine Locking Plate System (K000536, K000742)
Device Description
This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates and Bone Screws approved under K062310 and K040261: - Aviator plates in 1-level, 2-level, 3-level, and 4-level
1
Intended Use
Special 510(k) Premarket Notification
configurations and in lengths ranging from 12mm through 96mm
- Aviator 4.0 mm and 4.35mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle selfdrilling and fixed-angle sclf-tapping)
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:
- 트 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) 트
- 트 Tumors
- 트 Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- . Pseudarthrosis
- Failed previous fusion
- Decompression of the spinal cord following total or partial D cervical vertebrectomy
- I Spondylolisthesis
- . Spinal stenosis
WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates. The predicate Reflex® Hybrid Anterior Cervical Plate (ACP) System consists of various size plates that are implanted and remain static. The subject system introduces various length plates that contain a new "spring bar" anti-backout mechanism similar to the existing Reflex Hybrid "locking ring" anti-backout mechanism. In addition to the new anti-backout mechanism
Summary of the Technological Characteristics
Page 2 of 3
2
introduced on the Aviator plate, new screws have been introduced with a modified head. Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems.
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 & 2009
Stryker Corp. % Ms. Vikki M. O'Connor 2 Pearl Court Allendale, NJ 07401
Re: K083562
Trade/Device Name: Aviator Anterior Cervical Plating (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 11, 2009 Received: March 13, 2009
Dear Ms. O'Connor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enoredary to regions of the Medical Device Amendments, or to commerce pror to May 20, 1970, are eccordance with the provisions of the Federal Food, Drug, devices that have been route approval of a premarket approval application (PMA). and Cosmetic (110-) that to novice, subject to the general controls provisions of the Act. The I ou may, merelore, market of the Act include requirements for annual registration, listing of general controls provisions of the rise labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is viassified (666 acre) arols. Existing major regulations affecting your device . EDA It inay be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA ean be louits in the Outsuneements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advisou mate I DTT 3 loseanse over device complies with other requirements of the Act that I D'i has inder a determistions administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Compry with an the riot 81 cFR Part 801); good manufacturing practice requirements as set Crit Fart 807), idocing (21 OFRT art 820), and if applicable, the electronic forth in the quality bybections (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Vikki M. O'Connor
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mollenkamp
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K 083562
Device Name: Stryker Spine Aviator Anterior Cervical Plating (ACP) System
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 unilatcral 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) 트
- Pseudarthrosis ■
- I Failed previous fusion
- Decompression of the spinal cord following total or partial cervical vertebrectomy
- Spondylolisthesis
- I Spinal stenosis
WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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 General, Restorative,
and Neurological Devices
510(k) Number K083562