(67 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical implant system (plates and screws) and does not mention any software, image processing, or AI/ML terms.
Yes
The device is described as an anterior intervertebral screw fixation system for temporary stabilization of the anterior spine during the development of cervical spine fusions, intended for various medical conditions like Degenerative Disc Disease, trauma, tumors, etc. This clearly indicates a therapeutic purpose.
No
The device is described as an anterior intervertebral screw fixation system for the cervical spine, intended for temporary stabilization during fusion development. Its description focuses on its mechanical components (bone plates and screws) and its function in stabilization and fusion, rather than diagnosing conditions.
No
The device description explicitly states that the Reflex™ ACP System consists of bone plates and screws, which are hardware components fabricated from titanium alloy.
Based on the provided information, 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" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used in vivo (within the body) for structural support and stabilization.
- Device Description: The device is described as "bone plates and screws" fabricated from titanium alloy. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or 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 directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The Reflex™ 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 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 and 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
87 KWQ
Device Description
The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy. The implants will be provided non-sterile.
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
Static and fatigue test results show the Reflex ACP System demonstrated comparable mechanical properties to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Synthes' Cervical Spine Locking Plate (CSLP) System
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
Reflex™ Anterior Cervical Plate System -- Additional Indications
510(k) Premarket Notification
510(k) Summary for Reflex" Anterior Cervical Plate System - Additional Indications
| Proprietary Name: | Reflex™ Anterior Cervical Plate System |
|---|---|
| Common Name: | Anterior Cervical Plate System |
| Proposed Regulatory Class: | Class II |
| Classification Name and Reference: | Spinal Invertebral Body Fixation Orthosis |
| 21 CFR §888.3060 | |
| Device Product Code: | 87 KWQ: Appliance, Fixation, Spinal Intervertebral Body |
| For Information contact: | Karen Ariemma |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: kariemma@howost.com | |
| Date Summary Prepared: | May 30, 2003 |
The purpose of this premarket notification is to add indications to the Reflex " Anterior Cervical Plate (ACP) System.
Predicate Device Information:
The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy. The implants will be provided non-sterile. The following system was already determined substantially equivalent for the desired indications: Synthes' Cervical Spine Locking Plate (CSLP) System.
Intended Use:
The Reflex™ 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 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 and spinal stenosis.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Performance Data:
Static and fatigue test results show the Reflex ACP System demonstrated comparable mechanical properties to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K031702
Trade/Device Name: Reflex™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: May 30, 2003 Received: June 2, 2003
Dear Ms. Ariemma:
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.
2
Page 2 - Ms. Karen Ariemma
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
O Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K ∞ 3 170 x
Device Name: Reflex Anterior Cervical Plate System
The Reflex 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 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 .
- 6 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Muriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K031702