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.

AI/ML Overview

The submission K103001 for the DePuy Rockwood Clavicle Pin describes the acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Torque testing:	The new Rockwood Clavicle Pin performed equivalently to the predicate device during torque testing. Specific quantitative values for torque were not provided in the summary. The implied criterion is that the new device's torque resistance is not significantly worse than, and ideally equivalent to or better than, the predicate.
Bone model evaluations:	The new Rockwood Clavicle Pin performed equivalently to the predicate device in bone model evaluations. Specific performance metrics (e.g., pull-out strength, mechanical stability within the bone model) were not explicitly detailed in the summary, but the implied criterion is that its performance in a simulated bone environment is not inferior to the predicate.
Material Equivalence: (Implied)	The pins are stainless steel, matching the material of the predicate device.
Design Characteristics Equivalence: (Implied)	Design characteristics are the same among the various pins, differing only in diameter, threaded length, and overall length, and introducing a shorter 5" overall length in the 2.5mm configuration with corresponding scaled down thread lengths. The implied criterion is that the fundamental design principles and functional aspects remain consistent with the predicate.

Study Details:

The submission describes a study to prove substantial equivalence:

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: Not explicitly stated. The summary refers to "torque testing" and "bone model evaluations," implying a series of tests, but does not provide the number of pins or bone models tested.
Data Provenance: The tests were conducted internally by DePuy Orthopaedics, Inc. (manufacturer). The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This type of information is not applicable to this submission. The "ground truth" here is established through engineering and mechanical testing against predefined performance criteria, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

This is not applicable. The assessment is based on quantitative measurements from mechanical and bone model tests against established criteria, not on subjective expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This study is for a medical device (bone fixation fastener), not an AI algorithm for diagnostic imaging.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, this is not relevant to the device being submitted. This device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance demonstration is based on engineering performance specifications and comparative mechanical testing results against a predicate device. This includes:

Physical measurements and experimental data from torque tests.
Mechanical performance in controlled bone model environments.
Material and design specifications.

8. The Sample Size for the Training Set:

Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set, this question is not relevant.

Summary

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K103001
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510(k) Summary

FEB 17 2011

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6441
Contact Person:Date Prepared:	Suzana Otaño, Project Manager, Regulatory AffairsOctober 5, 2010
General Provisions	The name of the device is: Proprietary Name Common or Usual Name Rockwood Clavicle Pin Smooth or Threaded Metallic BoneFixation Fastener
Name ofPredicateDevices	The device is substantially equivalent to the currently marketed DePuyRockwood Clavicle Pin System, K991649.
Classification	Class II, 21 CFR 888.3040, Smooth or Threaded Metallic Bone FixationFastener, 87 JDW
PerformanceStandards	Performance standards have not been established by the FDA undersection 514 of the Food, Drug and Cosmetic Act for these devices.
DeviceDescription	The Rockwood Clavicle Pin System offers various diameter and lengthstainless steel threaded pins with pre-loaded nuts. The devices are offeredin 5" and 6" overall lengths where the 6" pin ranges in diameter from2.5mm - 4.5mm and the 5" pin has a 2.5mm diameter.
Indications forUse	The Rockwood Clavicle Pin System is intended to be used to repair anacute fracture, mal-union or non-union of the clavicle.
TechnologicalCharacteristics	The technological characteristics of the Rockwood Clavicle Pin Systemare similar to the current Rockwood Clavicle Pin in both design andmaterial. The pins are stainless steel and design characteristics are thesame among the various pins which differ in diameter, threaded lengthand overall length. The new Rockwood Clavicle Pin provides a shorter 5"overall length in the 2.5mm configuration with corresponding scaled downthread lengths.

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K103001
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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.

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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

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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

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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

Regulation Number and Section

§ 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.