(72 days)
Not Found
No
The summary describes a mechanical implant system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a system intended for temporary stabilization and fusion in patients with various spinal conditions, which falls under the definition of a therapeutic device.
No
This device is a cervical plate system intended for temporary stabilization and fixation of the anterior spine; it does not diagnose medical conditions.
No
The device description explicitly states it consists of bone plates, screws, and associated instruments made from titanium alloy, which are physical 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. These tests are performed outside of the body.
- Device Description: The REMEDY™ Cervical Plate System is an implantable device used for surgical fixation of the cervical spine. It is physically implanted into the patient's body.
- Intended Use: The intended use is for temporary stabilization of the spine during fusion, addressing conditions like degenerative disc disease, trauma, tumors, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant and its intended use in treating spinal conditions, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions. WARNING: This device is not intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical Plate System implant components are made from titanium alloy described by ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to T1 of the cervical spine, anterior spine
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)
Non-Clinical Tests: Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion Tests per ASTM F1717 demonstrate the REMEDY Cervical Plate System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021461, K042922, K992110, K030327, K052552, K042544, K040655, K040261, K022344, K070775, K030866, K000536, K060442, K071329, K023281
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
REMEDY™ Cervical Plate System
510(K) SUMMARY
| Submitter | ArchiMed Inc.
50 W 3rd Ave
Collegeville, PA 19426
(800) 991-4559 | Date: | April 7, 2010 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------|
| | | Contact: | Barry Aiken
ArchiMed Inc
50 W 3rd Ave
Collegeville, PA 19426 |
| Trade Name | REMEDY™ Cervical Plate System | | |
| Common Name | Cervical Plating Instrumentation | APR - 7 2010 | |
| Classification | KWQ – 888.3060
Class II, Spinal Intervertebral Body Orthosis | | |
| Device Description | The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates,
screws, and associated instruments. Fixation is provided by bone screws inserted into the
vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical
Plate System implant components are made from titanium alloy described by ASTM F136. | | |
| Indications for Use | The REMEDY Cervical Plate System is intended for anterior interbody screw/plate fixation
from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior
spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc
Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed
by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4)
Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed
previous fusions. | | |
| | WARNING: This device is not intended for screw attachment to the posterior elements
(pedicles) of the cervical, thoracic, or lumbar spine. | | |
| Non-Clinical Tests | Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion
Tests per ASTM F1717 demonstrate the REMEDY Cervical Plate System is substantially
equivalent to the predicate devices. | | |
| Predicate Devices | The REMEDY Cervical Plate System has identical indications for use, material, and employs
the same principles of operation as predicate devices. Furthermore, its prominence on the
spine, range of sizes, and screw angulation are at or within the limits of the predicate devices.
Based on these factors, the REMEDY Cervical Plate System is Substantially Equivalent to
the predicate devices. | | |
| | Device | Company | 510(k) Number |
| | Atlantis Vision | Medtronic | K021461 |
| | Venture | Medtronic | K042922 |
| | Premeir | Medtronic | K992110 |
| | Zephir | Medtronic | K030327 |
| | Skyline | Depuy | K052552 |
| | Uniplate | Depuy | K042544 |
| | Swift | Depuy | K040655 |
| | Reflex Hybrid | Stryker Spine | K040261 |
| | Trinica Select | Zimmer | K022344 |
| | Providence | Globus | K070775 |
Vectra-T
Pyrenees
Helix ACP
Gradient Plus
CSLP
Synthes Spine
Synthes Spine
: 彩
K2M
Nuvasive
Nuvasive
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. To the left of the text is a symbol that appears to be three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ArchiMed, Inc. % Mr. Barry Aiken Chief Financial Officer 50 West 3rd Avenue Collegeville, Pennsylvania 19426
APR - 7 2010
Re: K100215
Trade/Device Name: REMEDY™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 19, 2010 Received: January 25, 2010
Dear Mr. Aiken:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
2
Page 2 - Mr. Barry Aiken
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Singerely yours.
Mark N. Melkersor Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K100215 |
|---|---|
| Device Name: | REMEDY™ Cervical Plate System |
| Indications for Use: | The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: |
| 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), | |
| 2) Trauma (including fractures), | |
| 3) Tumors, | |
| 4) Deformity (defined as kyphosis, lordosis, or scoliosis), | |
| 5) Pseudarthrosis, and/or | |
| 6) Failed previous fusions. | |
| Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. |
X Prescription Use (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIDOZIS 510(k) Number_