(155 days)
No
The summary describes a mechanical implant (bone plates and screws) and makes no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as plates used for fixation of fractures, which falls under surgical implantation for trauma rather than a therapeutic device in the sense of treating or alleviating a disease or condition through non-surgical means. It is a mechanical aid for healing.
No
The device is described as plates for fixation of fractures, which is a treatment, not a diagnostic function.
No
The device description clearly describes a physical titanium plate with PEEK-Optima® inserts and screws, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures in phalangeal and metacarpal bones." This describes a surgical implant used to stabilize broken bones within the body.
- Device Description: The description details a titanium plate with PEEK-Optima® inserts and screws, designed for surgical implantation.
- 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.
This device is a surgical implant, specifically an orthopedic device.
N/A
Intended Use / Indications for Use
The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.
Product codes
HWC, HRS
Device Description
The XXS Plates utilize the same integrated locking system for screws as the Xtremities Plates cleared in K050681. The titanium plates have PEEK-Optima® inserts which enables the screws to be locked at the desired angle by means of a "self-tapping" effect. The XXS Plats are thinner and smaller diameter screws (1.7mm) have been designed for use in small bones including the metacarpals and phalanges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalangeal and metacarpal 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
111266 Page 1/2
OCT - 6 2011
510(k) Summary of Safety and Effectiveness TRIMED EASYLOCK OSTEOSYSTEM XXS PLATES
| Submitted/Distributed By: | TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355
(800)633-7221 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 2031009 |
| Manufactured By: | Biotech International
305, Allée de Craponne
13300 Salon De Provence
France |
| Registration No.: | 3005270144 |
| Prepared By/Contact Person: | Doug Steinberger
Phone: (661)255-7406
Fax: (661)254-8485 |
| Proprietary Name: | Mini Plates or XXS Plates |
| Classification: | Class II: Screw, Fixation, Bone
HWC – Section 888.3040
Class II: Plate, Fixation, Bone
HRS - Section 888.3030 |
| Summary Preparation Date: | July 28, 2011 |
Indications for Use:
The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.
Device Description
The XXS Plates utilize the same integrated locking system for screws as the Xtremities Plates cleared in K050681. The titanium plates have PEEK-Optima® inserts which enables the screws to be locked at the desired angle by means of a "self-tapping" effect. The XXS Plats are thinner and smaller diameter screws (1.7mm) have been designed for use in small bones including the metacarpals and phalanges.
XXS Plates System – Summary of Safety and Effectiveness
1
K111266 Page 2/2
Substantial Equivalence Discussion
When compared to the predicate devices listed below, substantial equivalence is based upon similarities in design features and dimensions, overall indications for use, and material composition.
| 510(k) Number | Device Name or System | Manufacturer |
|---|---|---|
| K050681 | EasyLock Osteosystem | Manufactured By: |
| Biotech International | ||
| Distributed By: | ||
| TriMed, Inc. | ||
| K081546 | Small Bone Locking | |
| Plating System | DePuy Orthopaedics | |
| K961497 | Profyle Hand and Small | |
| Fragment System | Stryker, Howmedica |
The new product does not change the intended use or scientific principles used for safe and effective implantation.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling human figures or waves, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
TriMed Inc. % Doug Steinberger 27533 Avenue Hopkins Santa Clarita CA 91355
001 - 6 2011
Re: K111266
Trade/Device Name: EasyLock Osteosystem XXS Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS/HWC Dated: September 2010, 2011 Received: September 2316, 2011
Dear Mr. Steinberger:
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.
3
Page 2 - Mr. Doug Steinberger
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 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/About/DA/CentersOfTices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Pop
Mark N. Melkerson
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
unknown K11266 510(k) Number (if known):
EasyLock Osteosystem XXS Plates Device Name:
Indications For Use:
The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.
× 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)
Ntuhal Ches SnM
(Divi Division of Surgical, Orthopedic and Restora
510(k) Num
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