(10 days)
Not Found
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/ML.
Yes
The device is described as a system for "anterior intervertebral screw fixation of the cervical spine" and "intended for temporary stabilization of the anterior spine during the development of cervical spine fusions" for various medical conditions, indicating its direct role in treating these conditions.
No
The device is an anterior intervertebral screw fixation system intended for temporary stabilization of the cervical spine during fusion, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as plates, bone screws, and a locking ring component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to stabilize the cervical spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components (plates, screws, locking ring) are all designed for surgical implantation and mechanical support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition within the body.
N/A
Intended Use / Indications for Use
The Reflex™ Hybrid ACP 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 thefollowing indications:
· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by 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
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The Reflex™ Hybrid ACP System includes plates (1level, 2-level, 3-level, and 4-level), 4.0 mm and 4.5mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle self-drilling, and fixed-angle self-tapping), and a locking ring component. This submission adds three new 4-level plate lengths to the 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 demonstrated that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device system.
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
§ 888.3060 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
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Stryker Spine Reflex™ Hybrid ACP System
| Proprietary Name: | Reflex™ Hybrid ACP System
AUG 1 8 2006 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Simona Voic
Regulatory Affairs Project Manager
Stryker Spine
2 Pearl Court
Allendale, NJ 07401
Telephone: (201) 760-8145
Fax: (201) 760-8345
Email: Simona.Voic@stryker.com |
| Date Summary Prepared: | August 7, 2006 |
| Predicate Device | Reflex™ Hybrid ACP System (K040261)
Synthes Cervical Spine Locking Plate System
(K000536 and K000742) |
1
Intended Use
Device Description
The Reflex™ Hybrid ACP 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 thefollowing indications:
· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by 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
The Reflex™ Hybrid ACP System includes plates (1level, 2-level, 3-level, and 4-level), 4.0 mm and 4.5mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle self-drilling, and fixed-angle self-tapping), and a locking ring component. This submission adds three new 4-level plate lengths to the Reflex™ Hybrid ACP System.
2
Summary of the Technological Characteristics
The intended use and materials of the subject devices are identical to those of the predicate device system. Engineering analysis demonstrated that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device system.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) of the United States. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four human figures in profile, arranged in a row and connected by a continuous line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K062310
Trade/Device Name: Stryker Spine™ Reflex Hybrid ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 07, 2006 Received: August 8, 2006
Dear Ms. Voic:
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, and 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. Simona Voic
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Charles Bullworth
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stryker Spine Reflex™ Hybrid ACP System
Indications for Use:
The Reflex™ Hybrid ACP 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 with the following indications:
· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by 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
WARNING: This device is not approved for screw attachment 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Senbare michim
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K062310