(158 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a fixation system for ribs and sternum, consisting of plates, screws, and splints, used to stabilize and reconstruct fractures and deformities. It is an implantable surgical device, not a therapeutic device that delivers therapy or treatment in itself.
No
Explanation: The device is described as a fixation system for the chest wall, indicated for use in surgical reconstruction and stabilization of fractures and deformities. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it consists of locking plates, locking screws, and intramedullary splints, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The MatrixRIB Fixation System is described as consisting of "locking plates, locking screws, and intramedullary splints for fixation and stabilization of the chestwall." These are implants designed to be surgically placed inside the body to fix bones.
- Intended Use: The intended use is for "fixation, stabilization, and reconstruction of fractures, fusions, osteotomies, and/or resections of the ribs and sternum, including spanning gaps and/or defects" and "Pectus Excavatum, Pectus Carinatum, and other chest wall deformities." This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used for structural support and repair within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for the fixation, stabilization, and reconstruction of:
- fractures, fusions, osteotomies, and/or resections of the ribs and sternum, including . spanning gaps and/or defects
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities .
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The MatrixRIB Fixation System consists of locking plates, locking screws, and intramedullary splints for fixation and stabilization of the chestwall. These implants are available in multiple sizes and are manufactured from titanium alloy (Ti-6Al-7Nb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ribs and sternum, chest wall
Indicated Patient Age Range
skeletally mature patients
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 included:
- Dynamic compression bending of plates
- Cantilever bending of plates
- Torque testing and pull-out strength of screws
The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Fixation Systemis 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.
K081623, K112689, K093772, K081700, K050041, K010943, K073556
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif letters on the right. A horizontal line is present below the word "SYNTHES".
5 510(k) Summary
K133616 Page 1 of 3
| Date Prepared | April 30, 2014 |
|---|---|
| Submitter | Synthes (USA) Products LLC |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact | Damon Lees |
| lees.damon@synthes.com | |
| (610) 719-5608 |
Device Name MatrixRIB Plating System
(484) 356-9682 (fax)
Device Classification Information
| Product Code | Device Name | Device Class | Regulation Number | Regulation Description |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 21 CFR 888.3030 | Single/multiple component metallic bone fixation appliances and accessories |
The MatrixRIB Fixation System contains the above Class 2 implants and also includes Class 1 instruments and accessories.
Predicate Devices
- Synthes MatrixRIB Fixation System (K081623) .
- Synthes Sternal Fixation System (K112689, K093772, K081700, K050041, . K010943)
- MedXpert STRATOS (K073556) .
Indications for Use
The MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for the fixation, stabilization, and reconstruction of:
- fractures, fusions, osteotomies, and/or resections of the ribs and sternum, including . spanning gaps and/or defects
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities .
Device Description
The MatrixRIB Fixation System consists of locking plates, locking screws, and intramedullary splints for fixation and stabilization of the chestwall. These implants are available in multiple sizes and are manufactured from titanium alloy (Ti-6Al-7Nb).
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 stylized image inside. A horizontal line is present underneath the word. The logo and text are in black and white.
510(k) Summary (continued) 5
Comparison to Predicate Devices
Indications
The predicate devices are indicated for use in chest wall of the skeleton (i.e. ribs and sternum) for a variety of surgical applications (rib fixation, chest wall reconstruction, and chest wall deformity repair). The Indications for Use statement of the MatrixRIB Fixation System presented in this submission is a superset of the 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 not already addressed by the predicates.
Technological Similarities of the MatrixRIB Plates
- Same principles of operation as the existing MatrixRIB and Synthes Sternal Fixation . System predicates, i.e. metallic plates that can be fixated to bone.
- Similar sizes and shapes compared to the predicates. .
- Proposed 24-hole and 30-hole straight plates have the same thickness and curved . cross-section as the existing MatrixRIB universal plate.
- Proposed plates have the same locking screw hole design as the existing predicate . MatrixRIB plate, and therefore are compatible with the existing MatrixRIB screws.
- Same material as the existing MatrixRIB plates. .
Technological Differences of the MatrixRIB Plates
- MatrixRIB sternal plates (made from Titanium alloy) are thinner than the Synthes . Sternal Fixation System predicate plates (made from commercially pure Titanium).
- Most plates in the predicate Synthes Sternal Fixation System have an emergency . release pin; no MatrixRIB plates contain an emergency release pin.
- The STRATOS predicate employs rib clips and connecting bars for fixation/repair . which are made from commercially pure Titanium; the MatrixRIB system employs plates and screws for fixation/repair which are made from Titanium alloy.
Technological Similarities of the MatrixRIB screws
- Same principles of operation metallic implants for the fixation of bone. .
- Similar lengths as the predicates. .
- Same solid shaft as the existing MatrixRIB Fixation System predicate. .
- Same thread pitch as the existing MatrixRIB Fixation System predicate. .
- Same material as the predicates. .
Technological Differences of the MatrixRIB screws
- The major diameter of the MatrixRIB screw is slightly smaller than the Synthes . Sternal Fixation System predicates.
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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 small circle with a dot in the center is located to the upper right of the word. A horizontal line is located underneath the word.
5 510(k) Summary (continued)
K133616 Page 3 of 3
Non-clinical performance data
Non-clinical testing and analyses comparing the proposed devices to the predicates within this submission include:
- Dynamic compression bending of plates .
- Cantilever bending of plates .
- Torque testing and pull-out strength of screws .
The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Fixation Systemis comparable to that of the predicates.
Clinical performance data
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence
The proposed deviceshave the same intended use as the predicate devices. The mechanical testing included in this submission demonstrates that:
- Any differences in technological characteristics of the predicates do not raise any . new questions of safety and effectiveness.
- The proposed devicesare at least as safe and effective as the predicates. .
It is concluded that the information included in this submission supports substantial equivalence.
(end of summary)
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2014
Synthes (USA) Products I.L.C Mr. Damon Lees Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K133616
Trade/Device Name: MatrixRIB Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 11, 2014 Received: April 14, 2014
Dear Mr. Lees:
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
4
Page 2 - Mr. Damon Lees
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 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" (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/Reportal/roblem/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 yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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4 Indications for Use Statement
510(k) Number (if known):
K133616 (pg 1/1)
Device Name:
MaxtrixRIB Fixation System
Indications for Use:
The MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for the fixation, stabilization, and reconstruction of:
- fractures, fusions, osteotomies, and/or resections of the ribs and sternum, including . spanning gaps and/or defects
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities .
Contraindications:
The MatrixRIB Fixation System is contraindicated for:
- The fixation of the sternum in acute cardiac patients, due to the potential delay if . emergent re-entry is required
- Screw attachment or fixation to the clavicle or spine .
- Use in patients with latent or active infection, with sepsis, or who are unwilling or . incapable of following postoperative care instructions
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Tara N. Shepherd