(125 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (plate and screws) for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for temporary stabilization of the anterior cervical spine during the development of solid fusion, which directly addresses various medical conditions such as degenerative disc disease, trauma, and spinal stenosis, thereby treating or alleviating a disease.
No
This device is an implantable surgical plate system designed for temporary stabilization of the cervical spine during bone fusion, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical implants (cervical plate lengths and bone screws) made of titanium alloy.
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 MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is an implantable device consisting of plates and screws made of titanium alloy. These are physical components intended to be surgically placed within the body.
- Intended Use: The intended use is for the "anterior interbody screw/ plate fixation of the cervical spine" and "temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion." This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used to stabilize the spine, not a diagnostic tool.
N/A
Intended Use / Indications for Use
MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/plate fixation of the cervical spine until the bone fusion occurs.
The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:
- degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis,
- and failed previous fusion
This implant has to be used with an appropriate bone graft.
Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.
Product codes
KWQ
Device Description
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is an anterior system, which consists of a variety of cervical plate lengths and a variety of cervical bone screws.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to 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)
The components of MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F1717-15.
Pyrogenicity testing was conducted in support to MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System component substantial equivalence.
No clinical data was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133518, K052763, K030866, K100070
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2016
Medicrea International S.A. David Ryan VP Product Development and Marketing 14 Porte Du Grand Lyon Neyron, 01700 France
Re: K162194
Trade/Device Name: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 10, 2016 Received: November 14, 2016
Dear Mr. Ryan:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Sincerely,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162194
Device Name
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
Indications for Use (Describe)
MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/ plate fixation of the cervical spine until the bone fusion occurs.
The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:
· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- · tumor,
- · pseudoarthrosis,
- · and failed previous fusion
This implant has to be used with an appropriate bone graft.
Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System:
Date Prepared: 02 August 2016
1. Submitter:
Contact Person:
MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR Phone Number : +33 4 72 01 87 87
David RYAN MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR
-
- Trade name: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
Regulatory Identification/ Classification
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Regulation Number: 21CFR 888.3060 Product Code: KWQ Class II
3. Predicate or legally marketed devices which are substantially equivalent:
Primary predicate:
- . MaxAn Anterior Cervical Plate System, (BIOMET SPINE, K133518)
Additional predicate:
- Stella Cervical Plate, (SCIENT'X, K052763) ●
- Synthes Spine Anterior CSLP System (SYNTHES SPINE, K030866)
- o Uniplate Anterior Cervical Plate System (DEPUY SPINE, K100070)
No reference devices were used in this submission.
Description of the device: ব
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is an anterior system, which consists of a variety of cervical plate lengths and a variety of cervical bone screws.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications.
Never use stainless steel and titanium implant components in the same construct.
4
To achieve best results, do not use any of the MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System components from any other systems or manufacturer unless specifically labeled to do so in this or another MEDICREA® INTERNATIONAL document.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-3
Function: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System was developed as an implant:
- · To provide immobilization and stabilization of anterior spinal segments
- to augment the development of a solid spinal fusion
- · to provide stability to ease fusion
- to be mechanically resistant to allow the fusion of the operated level
5. Indication for Use
MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/plate fixation of the cervical spine until the bone fusion occurs.
The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:
- degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis, ●
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ●
- . tumor,
- pseudoarthrosis,
- o and failed previous fusion
This implant has to be used with an appropriate bone graft.
Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.
6. Substantial equivalence claimed to predicate devices
MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate components are technologically similar to the already cleared Stella Cervical Plate: MaxAn Anterior Cervical Plate System, Synthes Spine Anterior CSLP System, and Uniplate Anterior Cervical Plate System from Depuv Spine components in terms of intended use, materials used, mechanical safety and performances.
The table below compares the features and characteristics of MEDICRA INTERNATIONAL Anterior Cervical Locking Plate components to their predicate devices.
5
| Device | MEDICREA
INTERNATIONAL
Anterior Cervical
Locking
Plate
System | BIOMET
SPINE
MaxAn
Anterior
Cervical
Plate
System | SYNTHES
SPINE
Anterior
CSLP
System | DEPUY
SPINE
Uniplate
Anterior
Cervical Plate | SCIENT'X
STELLA
Cervical Plate |
|----------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 510(k)
number | Unknown | K133518 | K030866 | K100070 | K132012 |
| Intended
use | | | | | |
| Anterior
Cervical | Yes | Yes | Yes | Yes | Yes |
| Components | | | | | |
| Cervical
Plate | 1-Level Plate
2-Level Plate
3-Level Plate
4-Level Plate | 1-Level Plate
2-Level Plate
3-Level Plate
4-Level Plate
5-Level Plate | 1-Level Plate
2-Level Plate
3-Level Plate
4-Level Plate | 1-Level Plate
2-Level Plate | 1-Level Plate
2-Level Plate
3-Level Plate
4-Level Plate
5-Level Plate |
| Cervical
Screws | Ø4mm &
Ø4.5mm
Variable and
fixed angles
screws available | Ø4mm &
Ø4.5mm
Variable and
fixed angles
screws
available | Ø4mm &
Ø4.35mm &
Ø4.5mm
Variable and
fixed angles
screws
available | Ø4,6mm &
Ø5.2mm | Ø4mm &
Ø4.5mm
Variable and
fixed angles
screws
available |
| Locking
Mechanism | | | | | |
| | Part turned
to
prevent
screw
back out | Based on
titanium
elasticity,
ring
deformation | Based on
Titanium
deformation,
a locking
screw is
screwed
within the
screw head | Part turned
to prevent
screw back
out | Part turned
to prevent
screw back
out |
| Materials | | | | | |
| | Titanium
Alloy
(Ti-6Al-4V)
according
to
ASTM F136
&
ISO 5832-3 | Titanium
Alloy (Ti-6Al-
4V)
according to
ASTM F136
& ISO 5832-
3 | Titanium
Alloy (Ti-6Al-
4V)
according to
ASTM F136
& ISO 5832-3 | Titanium
Alloy (Ti-6Al-
4V)
according to
ASTM F136
& ISO 5832-3 | Titanium
Alloy (Ti-6Al-
4V)
according to
ASTM F136
& ISO 5832-
3 |
7. Non-clinical Test Summary:
The components of MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F1717-15.
6
Pyrogenicity testing was conducted in support to MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System component substantial equivalence.
8. Clinical Test Summary
No clinical data was provided
9. Conclusions Non clinical and Clinical
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is substantially equivalent to legally marketed predicate device.