(72 days)
Not Found
No
The device description and intended use focus on mechanical fixation components (plates and screws) and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as being for "temporary stabilization of the anterior spine during the development of cervical spine fusions" and is indicated for conditions like "Degenerative Disc Disease," "trauma," "tumors," and "spinal stenosis," all of which are medical conditions that the device is intended to treat or mitigate.
No
The device is an anterior cervical plate system intended for temporary stabilization and fixation of the cervical spine, not for diagnosing medical conditions.
No
The device description explicitly states that the device consists of bone plates and screws fabricated from Titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Reflex™ ACP System and Reflex™ Hybrid ACP System consist of "bone plates and screws" intended for "anterior intervertebral screw fixation of the cervical spine." These are implanted devices used to stabilize the spine.
- Intended Use: The intended use is for "temporary stabilization of the anterior spine during the development of cervical spine fusions." This is a surgical procedure involving implantation, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Reflex™ ACP System and Reflex™ Hybrid ACP System are intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1.
The Reflex™ ACP System and Reflex™ Hybrid ACP System are 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.
Product codes
KWQ
Device Description
This submission is intended to expand the Reflex " ACP System product line by adding the Reflex" Hybrid ACP System, a low profile anterior cervical plate system, intendcd for unilateral fixation. Similar to its predicate device, the Reflex " Hybrid ACP System consists of bonc plates and screws, available in a variety of lengths. The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Reflex™ Hybrid ACP System 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been conducted demonstrating substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Spine's Reflex " Anterior Cervical Plate 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
Special 510(k) Summary of Safety and Effectiveness: Line extension to the Reflex Anterior Cervical Plate System
| Proprietary Name: | Reflex™ Hybrid 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: | Simona Voic |
| Regulatory Affairs Project Manager | |
| Stryker Spine | |
| 6 Pearl Court | |
| Allendale, NJ 07401-1677 | |
| Telephone: (201) 760-8145 | |
| Fax: (201) 760-8345 | |
| Email: Simona.Voic@stryker.com | |
| Date Summary Prepared: | January 27, 2004 |
Predicate Device Information:
Stryker Spine's Reflex " Anterior Cervical Plate 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 per ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants are provided non-sterile.
Description of Device Modification
This submission is intended to expand the Reflex " ACP System product line by adding the Reflex" Hybrid ACP System, a low profile anterior cervical plate system, intendcd for unilateral fixation. Similar to its predicate device, the Reflex " Hybrid ACP System consists of bonc plates and screws, available in a variety of lengths. The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Reflex™ Hybrid ACP System will be provided non-sterile.
Intended Use:
The Reflex" ACP System and Reflex " Hybrid ACP System are intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1.
Indication for Use:
The Reflex " ACP System and Reflex" Hybrid ACP System are 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.
1
- This device is not approved for screw attachment to the posterior elements WARNING: (pedicles) of the cervical, thoracic, or lumbar spine.
Statement of Technological Comparison:
Equivalency of the Reflex " Hybrid ACP System is based on similarities in intended use, indications for use, materials, and design to the predicate device. Testing has been conducted demonstrating substantial equivalence to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
Mr. Christopher McDonnell Vice President Global Technology Stryker Spine 6 Pearl Court Allendale, NJ 07401-1677
Re: K040261
Trade/Device Name: Reflex™ Hybrid Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 3, 2004 Reccived: February 4, 2004
Dear Mr. McDonnell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been be and 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 encreated of the enactment date of the Medical Device Amendments, or to commerce prof to this 2011-07-12, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controll province, 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 may be subject to back as a segulations, 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 r lease be devices and i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal 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 Erth 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.
3
Page 2 -- Mr. Christopher McDonnell
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letet 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" (21 CFR 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 vours.
Sincerely, John,
Mark McMillan
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
4
Indications for Use
510(k) Number (if known): K040261
Device Name: Reflex™ Hybrid Anterior Cervical Plate (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 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 vertebrectorny. .
- 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 × (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 | K040261 |
|---|---|
| Page 1 of | 1 |