(275 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of bone fixation implants, with no mention of AI or ML.
No
The device is intended for the fixation of cranial bones, which is a structural and reparative function rather than a therapeutic one that would treat or cure a disease or condition.
No
The device is described as a Cranial Plating System used for fixation of cranial bones in procedures, not for diagnosing conditions. Its primary function is to provide structural support and repair.
No
The device description explicitly states it consists of bone fixation implants, reconstruction meshes, and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies." This describes a surgical implant used directly on the patient's body.
- Device Description: The device consists of "bone fixation implants offered in a variety of shapes and sizes," "reconstruction meshes," and "screws." These are physical devices used in surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The Synthes MatrixNEURO Cranial Plating System is a surgical implant used for structural support and fixation within the body, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
GWO, GXR
Device Description
The Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with Synthes MatrixNEURO plates, burr hole covers, and meshes, may be offered sterile, and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bones
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 performance data compared the proposed devices to the predicates:
- . cross-sectional area
- section modulus .
- peak load at 2 mm of displacement .
- . stiffness at 2 mm of displacement
- . insertion torque
- failure torque .
- . insertion factor of safety
- pullout load . •
The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates.
Clinical testing was not necessary for the determination of substantial equivalence.
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.
K042365, K033160, K031807, K022012
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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
K1237223
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. The logo appears to be a stylized representation of a human figure. The word "SYNTHES" is written in all capital letters and has a slightly italicized appearance.
| 510(k) Summary | Page 1 of 3 | |
|---|---|---|
| Date Prepared | September 3, 2013 | |
| Submitter | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| United States of America | ||
| Contact | Alan T. Haley | |
| haley.alan@synthes.com | ||
| (484) 356-9763 | ||
| Device Name | Synthes MatrixNEURO Cranial Plating System | |
| Device Class | 2 | |
| Primary Product Code / Regulation Number |
GWO / 21 CFR 882.5320
Secondary Product Codes / Regulation Numbers
GXR / 21 CFR 882.5250
Predicate Devices
- . Synthes Neuro Plate and Screw System (K042365)
- Synthes Low Profile Contourable Mesh Plates (K033160) .
- Synthes Low Profile Neuro Plate and Screw System (K031807) .
- . Synthes Low Profile Neuro Plate and Screw System (K022012)
Indications for Use
The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Device Description
The Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with Synthes MatrixNEURO plates, burr hole covers, and meshes, may be offered sterile, and are intended for single use only.
SEP 05 2013
1
Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word. The registered trademark symbol is present to the right of the word.
510(k) Summary (continued)
Comparison to Predicate Devices
Indications
The predicate devices are indicated for use in a range of anatomic areas (midface, craniofacial skeleton, maxilla, chin) for a variety of surgical applications (craniofacial surgery, reconstructive procedures, selective orthognathic surgery). The Indications for Use statement of the Synthes MatrixNEURO Cranial Plating System falls within the scope of the broader Indications statements of the predicate devices. The differences in the Indications statement for the proposed device in comparison to the predicates do not constitute a new intended use.
Technological Similarities (Reconstruction Meshes)
- Same principles of operation metallic implants for the fixation of bone. ●
- Similar sizes and shapes compared to the predicates. .
- Same thickness as the Low Profile Contourable Mesh Plate predicate. .
- Same mesh pattern hourglass cut-outs to allow for similar intraoperative contourability. .
- Same screw recess inner diameter as the predicate Synthes Neuro Plate and Screw System, . and therefore compatible with same screws.
- Same strength-based color coding gradient as the predicate Synthes Neuro Plate and Screw . System mesh.
- Same material as the predicates. .
- The proposed reconstruction meshes are offered sterile. The meshes in the predicate Synthes . Neuro Plate and Screw System are offered sterile and non-sterile.
Technological Differences (Reconstruction Meshes)
- The bar width and screw recess outer diameter dimensions of the proposed devices are . greater than those of the predicates.
- The proposed Reconstruction Meshes feature a single-sided screw recess; the predicate . devices feature double-sided screw recesses.
Technological Similarities (Screws)
- Same principles of operation metallic implants for the fixation of bone. .
- . Similar lengths as the predicates.
- Same solid shaft as the Low Profile Neuro System predicates. .
- . Similar drive recess to the Low Profile Neuro System predicates.
- Similar type of tips on standard screw as the predicates. .
- Same type of tip on emergency screw as the predicates. .
- Same thread pitch as the Synthes Neuro Plate and Screw System predicate. .
- Same material as the predicates. .
- The proposed screws are offered sterile. The screws in the predicate Synthes . Neuro Plate and Screw System are offered sterile and non-sterile.
Technological Differences (Screws)
- The major diameter of the standard screw is slightly smaller than the Low Profile Neuro . System predicates.
2
Image /page/2/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word, adding emphasis to the brand name. The registered trademark symbol is located to the right of the word.
510(k) Summary (continued)
Page 3 of 3
Non-clinical performance data
Non-clinical performance data compared the proposed devices to the predicates:
- . cross-sectional area
- section modulus .
- peak load at 2 mm of displacement .
- . stiffness at 2 mm of displacement
- . insertion torque
- failure torque .
- . insertion factor of safety
- pullout load . •
The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates.
Clinical performance data
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence
The proposed devices have the same intended use as the predicate devices. The non-clinical performance data included in this submission demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the predicate devices. It is concluded that the information included in this submission supports substantial equivalence.
(end of summary)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.
Food and Drog Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2013
Synthes (USA) c/o Alan T. Haley Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380
Rc: K123723
Trade/Device Name: Synthes MatrixNEURO Cranial Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR Dated: August 5. 2013 Received: August 6, 2013
Dear Mr. Haley:
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 Mav 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. Isting 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 cither 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 is 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Haley
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Jndustry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K123723
Device Name:
Synthes MatrixNEURO Cranial Plating System
Indications For Use:
The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123723
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