(168 days)
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for temporary stabilization and fusion in patients with various spinal conditions, indicating a therapeutic purpose.
No
This device is a surgical implant (anterior cervical plating system) used to aid in spinal fusion and provide temporary stabilization. It is not used to diagnose medical conditions but rather to treat them.
No
The device description clearly states it consists of physical components like plates and titanium clips, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "cervical spinal fusion" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "plating system" with "plates," "screws," and "clips." These are physical components designed to be implanted into the spine.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device described is a surgical implant used to aid in spinal fusion, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Stryker Spine Reflex® Translational Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Reflex® Translational 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:
- I Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- I Trauma (including fractures)
- 포 Tumors
- 프 Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- 트 Pseudarthrosis
- צ Failed previous fusion
- Decompression of the spinal cord following total or partial cervical vertebrectomy 트
- 트 Spondylolisthesis
- 트 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 approved under K000742 and K000536: Translational plates in 1-level, 2-level, 3-level, and 4-level configurations and in lengths ranging from 14mm through 96mm.
The predicate Reflex® Hybrid Anterior Cervical Plate (ACP) System consists of various size plates that are implanted and remain static. The subject system consists of various length plates that have Titanium clips which hold the plate in the "fully open" position. After the plate is placed and secured, Titanium clips are removed allowing the plate to decrease in size up to 2mm per level treated. This translational plate design uses the same screws and locking mechanism used in the predicate Stryker Spine Reflex® Hybrid ACP System.
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
Device Description
MAR 2 6 2009
Special 510(k) Summary of Safety and Effectiveness: Reflex Translational Anterior Cervical Plate System
Line Extension to the Stryker Spine Reflex® Hybrid ACP System
Reflex® Translational ACP System Proprietary Name: Common Name: Anterior Cervical Plate System Proposed Regulatory Class: Class II Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 Device Product Code: KWQ Sponsor: Stryker Spine For Information contact: Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8215 Fax: (201) 760-8415 Email: Kimberly.Lane(@stryker.com Date Summary Prepared: October 7, 2008 Predicate Device Stryker Spine Reflex® Hybrid ACP System (K062310,
K040261) and Synthes Spine Cervical Spine Locking Platc System (K000536, K000742)
This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates approved under K000742 and K000536: Translational plates in 1-level, 2-level, 3-level, and 4-level
page 1 of 3
1
configurations and in lengths ranging from 14mm through
96mm
Intended Use
The Stryker Spine Reflex® Translational Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Reflex® Translational 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)
- 피 Trauma (including fractures)
- Tumors
- E Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- 트 Pseudarthrosis
- 트 Failed previous fusion
- Decompression of the spinal cord following total or I partial cervical vertebrectomy
- 트 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 consists of various length plates that have Titanium clips which hold the plate in the "fully open" position. After the plate is placed and secured, Titanium clips are
Page 2 of 3
Summary of the Technological Characteristics
2
removed allowing the plate to decrease in size up to 2mm per level treated. This translational plate design uses the same screws and locking mechanism used in the predicate Stryker Spine Reflex® Hybrid ACP System. Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle with its wings spread.
Public Health Service
Stryker Spine % Ms. Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2009
Re: K083020
Trade/Device Name: Stryker Spine Reflex® Translational Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 23, 2009 Received: February 24, 2009
Dear Ms. Lane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Ms. Kimberly Lane
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 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 vours,
ely yours,
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K 083020
Device Name: Stryker Spine Reflex® Translational Anterior Cervical Plating System
Indications For Use:
The Stryker Spine Reflex® Translational Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Reflex® Translational 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:
- I Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- I Trauma (including fractures)
- 포 Tumors
- 프 Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- 트 Pseudarthrosis
- צ Failed previous fusion
- Decompression of the spinal cord following total or partial cervical vertebrectomy 트
- 트 Spondylolisthesis
- 트 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 AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CIRH, Office of Device Evaluation (ODE) |
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Division Sign-Off)
Division of General, Restorative,
and Neurological Devices page 1 of 1
| 510(k) Number | 1083020 |
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| --------------- | --------- |