(26 days)
No
The device description focuses on physical orthopedic implants and surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The "Mini Fragment Plates" are described as orthopedic implants used for stabilization and fixation of bone fragments. This falls under structural repair or replacement, not a therapeutic treatment.
No
The device is described as orthopedic plates and fasteners for surgical fixation of bone fragments, which indicates a therapeutic or reparative function, not a diagnostic one.
No
The device description explicitly states that the device is a set of orthopedic plates, fasteners, and tools, which are physical hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization and fixation of small bone fragments" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of orthopedic plates, fasteners, and surgical tools. These are all used in a surgical setting for physical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant and instrument system used for structural support within the body.
N/A
Intended Use / Indications for Use
The proposed Mini Fragment Plates are intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.
Product codes
KTT
Device Description
The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires.
Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools.
In addition, the following are non-reusable instruments included in the sterilization tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.
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.
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K061748 1 of 2 00
JUL 1 7 2006
510(k) Summary of Safety and Effectiveness
| Name, Address
and
Establishment
Registration
| No. | The address and registration number of the manufacturer is as follows: | |
|---|---|---|
| Hand Innovations, LLC | ||
| 8905 SW 87 Avenue, Suite 220 | ||
| Miami, FL 33176-2227 | ||
| Establishment Registration No.: 9042874 | ||
| Tel.: (305) 270-6899 | ||
| Fax: (305) 412-8060 | ||
| General | ||
| Provisions | The name of the device is: | |
| Proprietary Name | Common or Usual Name | |
| Mini Fragment Plates | Plate Fixation Bone |
| Name of
Predicate
Devices | The device is substantially equivalent to:
• Fragment Plate System (510(k) # K041081 - July 1, 2003) - Hand Innovations,
LLC. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II. |
| Performance
Standards | Performance standards have not been established by the FDA under section 514 of
the Food, Drug and Cosmetic Act. |
| Indications for
Use | The proposed Mini Fragment Plates are intended for essentially non load bearing
stabilization and fixation of small bone fragments in fresh fractures, revision
procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist,
ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton. |
:
:
1
K061748 (pg 2 of 2)
| Device
Description | The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners
supplied in a sterilization tray together with several reusable and disposable tools.
The set of orthopedic plates and fasteners provided in the sterilization tray consists of
the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools. | |
| | In addition, the following are non-reusable instruments included in the sterilization
tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits. | |
| Biocompati-
bility | The Proposed Mini Fragment Plates do not require biocompatibility testing because
the material is the same as the previously approved Fragment Plate System. The
material is Ti-6Al-4V ELI per ASTM F 136-00 and also has a long history of safe
use in the Orthopedic industry. | |
| Summary of
Substantial
Equivalence | The proposed Mini Fragment Plates has the following similarities to the previously
cleared Fragment Plate System : (K041081). Have the same indications for use and intended use Have the same basic shape/design Use the same operating principle Utilize the same materials | |
| | In summary, the changes incorporated in the proposed Mini Fragment Plates do not
alter the fundamental scientific technology of the predicate device and therefore, in
our opinion, is substantially equivalent to the predicate Fragment Plate System. | |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hand Innovations, LLC % DePuv Orthopaedics, Inc. Ms. Natalie S. Heck Manager of Regulatory Affairs 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581
JUL 1 7 2006
Re: K061748
Trade/Device Name: Mini Fragment Plates Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulation Class: II Product Code: KTT Dated: June 19, 2006 Received: June 21, 2006
Dear Ms Heck:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
3
Page 2 – Ms. Natalie S. Heck
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K061748
Indications for Use
510(k) Number (if known): Device Name: Mini Fragment Plates
Indications for Use:
The Fragment Plate System is intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Larbere Buck MD for Myra
Division Sign Off
(Posted Nove Storas i and Neurological Devices
Page of of
510(k) Number K061746
Mini Fragment Plate System Special 510(k)
0000026