(29 days)
Not Found
No
The summary describes a mechanical implant (plate and peg) for fracture fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "plate system" intended for "fixation of fractures and osteotomies," which are medical interventions for treating conditions, thus making it a therapeutic device. The mention of pre-clinical testing also suggests medical application and therapeutic intent.
No
This device is a plate system for fixing fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Multidirectional Threaded Peg" manufactured from Cobalt Chromium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the fixation of fractures and osteotomies involving the distal radius." This describes a surgical implant used to stabilize bone, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is a "Multidirectional Threaded Peg" made of Cobalt Chromium. This is a physical implant, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic or prognostic information
This device is clearly a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Multidirectional Threaded Pegs have the same indications for use as the predicate device: The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
LXT
Device Description
The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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 equivalence was confirmed through pre-clinical testing.
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
K060864 Rge/1
:
:
| 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 | |
| Multidirectional Threaded Peg | Plate Fixation Bone | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| Threaded Peg of the Distal Volar Radius Anatomical Plate System (510(k) # K050932 – April 26, 2005) – 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 Multidirectional Threaded Pegs have the same indications for use as the predicate device: |
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius. | |
| Device
Description | The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies. | |
| Biocompati-
bility | The Proposed Multidirectional Threaded Peg do not require biocompatibility testing because the CoCr Alloy used in the fabrication meets the requirements of ASTM F 1537-00. | |
| Summary of
Substantial
Equivalence | The proposed Multidirectional Threaded Peg is substantially equivalent to the predicate threaded peg of the Distal Volar Radius Anatomical Plate System. The equivalence was confirmed through pre-clinical testing. | |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2006
Hand Innovations c/o Ms. Natalie S. Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 8905 SW 87th Avenue, Suite 220 Miami, Florida 33176
Re: K060864
Trade/Device Name: Multidirectional Threaded Peg Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: LXT Dated: April 24, 2006 Received: April 26, 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 Codc 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 I'DA`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
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Page 2 - Ms. Natalie S. Heck
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lemmer
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K060864
Device Name: Multidirectional Threaded Peg
Indications for Use Statement
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF, NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V OR
Over-The-Counter Use
Helier Lescano
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060864