(123 days)
Not Found
No
The summary describes a mechanical fixation system with plates and screws, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for fixation of fractures, osteotomies, and nonunions, which are conditions that require therapeutic intervention to promote healing and restore function.
No
The device is a fixation system intended for the treatment of fractures, osteotomies, and nonunions. It is a surgical implant designed to provide stability, not to diagnose a condition.
No
The device description explicitly states it includes physical components such as plates and screws made of metal and polymer, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula." This describes a surgical implant used to stabilize bones within the body.
- Device Description: The description details plates and screws, which are physical components used in orthopedic surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The Stabiliz Fixation System is an orthopedic implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.
Product codes
HWC, HRS
Device Description
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, fully-threaded cancellous screws, and partially-threaded cancellous screws in various sizes and geometries. The SPL Locking Screw is a metal locking screw with a resorbable threaded polymer collar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, radius, ulna, distal tibia, and fibula
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
Preclinical Testing: The non-clinical tests performed by the company include in vitro degradation testing, biomechanical loading study, corrosion testing, and biocompatibility testing. The results demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K120651, K123918, K101696, K020872, K033233
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K130731 JUL 1 9 2013 Page 1 of 2
510(k) Summary
| Device Trade Name: | Stabiliz Fixation System with SPL Locking Screw |
|---|---|
| Manufacturer: | Stabiliz Orthopaedics, LLC |
| 665 Stockton Drive | |
| Exton, PA 19341 | |
| Contact: | Douglas L. Cerynik, MD |
| President & CEO | |
| Stabiliz Orthopaedics, LLC | |
| 665 Stockton Drive | |
| Exton, PA 19341 | |
| Office: (610) 458-8555 | |
| cerynik@stabilizorthopaedics.com | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| Fax: 202.552.5798 | |
| Date Prepared: | July 18, 2013 |
| Classifications: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation |
| fasteners | |
| and | |
| 21 CFR 888.3030: Single/multiple component metallic bone | |
| fixation appliances and accessories | |
| Class: | II |
| Product Codes: | HWC and HRS |
Indications for Use:
The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.
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Device Description:
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, fully-threaded cancellous screws, and partially-threaded cancellous screws in various sizes and geometries. The SPL Locking Screw is a metal locking screw with a resorbable threaded polymer collar.
Predicate Devices:
Data provided in the 510(k) support the substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Stabiliz Fixation System (K120651); Zimmer® MotionLoc Screws (K123918 and K101696); Synthes 3.5mm Broad LC-DCP Plate (K020872); and Biomet Orthopedics Lactosorb® Tibial L-15 Screw and Washer (K033233).
Substantial Equivalence:
The components of the Stabiliz Fixation System are substantially equivalent to the identified predicates with respect to indications for use, geometry, available sizes, materials, methods of fixation to bone, and performance.
Preclinical Testing:
The non-clinical tests performed by the company include in vitro degradation testing, biomechanical loading study, corrosion testing, and biocompatibility testing. The results demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed predicate devices.
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Image /page/2/Picture/0 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 perimeter. In the center of the circle is a symbol consisting of three stylized human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2013
Stabiliz Orthopaedics, LLC % Douglas L. Cerynik,M.D. President & CEO 665 Stockton Drive Exton, Pennsylvania 19341
Re: K130731
Trade/Device Name: Stabiliz Fixation System with SPL Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 18, 2013 Received: June 19, 2013
Dear Dr. Cerynik:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Douglas L. Cerynik, M.D
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/Industry/default.htm.
Sincerely vours.
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K130731
Device Name: Stabiliz Fixation System with SPL Locking Screws
The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.
V Prescription Use (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 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)
Lori A. Wiggins
Division of Orthopedic Devices
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