(270 days)
Not Found
No
The summary describes a mechanical fixation system with plates and screws and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" states the device is "intended for fixation of fractures, osteotomies and nonunions," which are medical conditions, and thus the device functions to treat or alleviate these conditions.
No
The device is a fixation system for fractures, osteotomies, and nonunions, not a device used to diagnose medical conditions.
No
The device description explicitly lists hardware components (plates and screws) as part of the system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Stabiliz Fixation System is for the fixation of fractures, osteotomies, and nonunions of various bones. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of plates and screws, which are implants used to stabilize bone. This is consistent with a surgical fixation device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Stabiliz Fixation System does not fit this description.
N/A
Intended Use / Indications for Use
The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical tests performed by the company include an analysis of strength of the Stabiliz Fixation System plates and screws relative to legally marketed plates and screws. The analyses demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed 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.
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
Stabiliz Fixation System Device Trade Name: Stabiliz Orthopaedics, LLC Manufacturer: NOV 2 7 2012 3225 Arch Street Philadelphia, PA 19104 Douglas L. Cerynik, MD Contact: President & CEO Stabiliz Orthopaedics, LLC 3225 Arch Street Philadelphia, PA 19104 Office: (973) 714-5985 Fax: (202) 552- 5798 cerynik@stabilizorthopaedics.com Musculoskeletal Clinical Regulatory Advisers, LLC Prepared by: 1331 H Street NW, 12th Floor Washington, DC 20005 Phone: 202.552.5800 Fax: 202.552.5798 Date Prepared: November 16, 2012 Classifications: 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories and 21 CFR 888.3040: Smooth or threaded metallic bone fixation fasteners Class: II HRS, HWC Product Codes:
510(k) Summary
Indications for Use:
Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
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Device Description:
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.
Predicate Devices:
Comparative information presented in the 510(k) supports the substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684); and Zimmer® Universal Locking System (K060710).
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 an analysis of strength of the Stabiliz Fixation System plates and screws relative to legally marketed plates and screws. The analyses demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 27, 2012
Stabiliz Orthopaedics, LLC % Douglas L. Cerynik, M.D. President & Chief Executive Officer 3225 Arch Street Philadelphia, Pennsylvania 19104
Re: K120651
Trade/Device Name: Stabiliz 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, HWC Dated: November 19, 2012 Received: November 19, 2012
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
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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 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.
Sincerely yours.
Ronald P. Jean 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 4.
K120651 510(k) Number (if known): _
Device Name: Stabiliz Fixation System
The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Prescription Use V (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices
2012.11.23 09:42:07 -05'00'