(134 days)
Not Found
No
The summary describes a mechanical implant (pins and nuts) for bone repair and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as repairing acute fractures, mal-unions, or non-unions of the clavicle, which are therapeutic actions.
No
This device is a surgical implant designed to repair clavicle fractures, not to diagnose medical conditions. Its purpose is treatment, not diagnosis.
No
The device description clearly states it is a system of stainless steel threaded pins, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Rockwood Clavicle Pin System is a surgical implant used to repair bone fractures. It is physically inserted into the body and does not involve the analysis of bodily specimens.
Therefore, based on the provided information, the Rockwood Clavicle Pin System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Rockwood Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Product codes (comma separated list FDA assigned to the subject device)
JDW
Device Description
The Rockwood Clavicle Pin System offers various diameter and length stainless steel threaded pins with pre-loaded nuts. The devices are offered in 5" and 6" overall lengths where the 6" pin ranges in diameter from 2.5mm - 4.5mm and the 5" pin has a 2.5mm diameter.
The technological characteristics of the Rockwood Clavicle Pin System are similar to the current Rockwood Clavicle Pin in both design and material. The pins are stainless steel and design characteristics are the same among the various pins which differ in diameter, threaded length and overall length. The new Rockwood Clavicle Pin provides a shorter 5" overall length in the 2.5mm configuration with corresponding scaled down thread lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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 Rockwood Clavicle Pin is substantially equivalent to the predicate device as confirmed through testing. Torque testing and bone model evaluations demonstrated that the new Rockwood Clavicle pin performed equivalently to the predicate device, successfully meeting the predetermined acceptance criteria.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K103001
pg 1/2
510(k) Summary
FEB 17 2011
| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6441 | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person:
Date Prepared: | Suzana Otaño, Project Manager, Regulatory Affairs
October 5, 2010 | | | | |
| General Provisions | The name of the device is: Proprietary Name Common or Usual Name Rockwood Clavicle Pin Smooth or Threaded Metallic Bone
Fixation Fastener | | | | |
| Name of
Predicate
Devices | The device is substantially equivalent to the currently marketed DePuy
Rockwood Clavicle Pin System, K991649. | | | | |
| Classification | Class II, 21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation
Fastener, 87 JDW | | | | |
| Performance
Standards | Performance standards have not been established by the FDA under
section 514 of the Food, Drug and Cosmetic Act for these devices. | | | | |
| Device
Description | The Rockwood Clavicle Pin System offers various diameter and length
stainless steel threaded pins with pre-loaded nuts. The devices are offered
in 5" and 6" overall lengths where the 6" pin ranges in diameter from
2.5mm - 4.5mm and the 5" pin has a 2.5mm diameter. | | | | |
| Indications for
Use | The Rockwood Clavicle Pin System is intended to be used to repair an
acute fracture, mal-union or non-union of the clavicle. | | | | |
| Technological
Characteristics | The technological characteristics of the Rockwood Clavicle Pin System
are similar to the current Rockwood Clavicle Pin in both design and
material. The pins are stainless steel and design characteristics are the
same among the various pins which differ in diameter, threaded length
and overall length. The new Rockwood Clavicle Pin provides a shorter 5"
overall length in the 2.5mm configuration with corresponding scaled down
thread lengths. | | | | |
1
K103001
pg2/2
Summary of Substantial Equivalence
The Rockwood Clavicle Pin is substantially equivalent to the predicate device as confirmed through testing. Torque testing and bone model evaluations demonstrated that the new Rockwood Clavicle pin performed equivalently to the predicate device, successfully meeting the predetermined acceptance criteria.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DePuy Orthopaedics. Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw. Indiana 46581
FEB 17 2011
Re: K103001
Trade/Device Name: DePuy Rockwood Clavicle Pin Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: January 20, 2011 Received: January 21, 2011
Dear Ms. Otaño:
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 10 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. Iisting 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
3
Page 2 - Ms. Suzana Otaño
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/AboutFDA/CentersOffices/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 no mber (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fin Dilitin
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K103001 510(k) Number:
DePuy Rockwood Clavicle Pin Device Name:
Indications For Use:
The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter_ (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)
for M. Makkerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K103001