The DePuy Rockwood Clavicle Pin consists of three sub-components, a pin and two nuts, and is provided pre-assembled. The clavicle pin has machine threads on one end and cancellous threads on the other end. The clavicle pin has a trocar point on the machine thread end and two nuts on the cancellous thread end. The pin is available in four diameters, 2.5, 3.0, 3.8 and 4.5mm, in one length, 152mm. The two locking nuts have slightly varying outer diameters. One nut is tightened on the pin to compress the fracture and prevent pin migration. The second nut is used to lock the first nut in place. The two sub-component nuts are also available separately.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) submission does not provide specific acceptance criteria or an analytical or clinical study demonstrating the device's performance against such criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. This means that the manufacturer is asserting that their new device is as safe and effective as devices already legally marketed, without needing to conduct new performance studies.

Therefore, many of the requested categories will be "N/A" or "Not Applicable" because the basis for clearance is not through direct performance testing against acceptance criteria, but rather a comparison to existing devices.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
N/A (No specific performance criteria stated for this 510(k) submission as clearance is based on substantial equivalence to predicate devices.)	N/A (No performance data is presented against specific criteria. The submission focuses on demonstrating similarity to predicate devices in design, material, and intended use.)

Supporting Study Details

Sample size used for the test set and the data provenance: N/A - No specific test set for performance evaluation was conducted. The submission relies on existing marketing history and literature for predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - No ground truth established as part of a performance study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A - No performance study or adjudication process mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A - This device is a physical medical implant (clavicle pin), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: N/A - This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A - No ground truth was established for a new performance study. The "ground truth" for the substantial equivalence argument is implied by the established safety and effectiveness of the predicate devices. The document mentions "Published and unpublished literature documents the use of Hagie, modified Hagie, and Knowles pins in the treatment of clavicle fractures thereby justifying the use of the very similarly designed Rockwood Clavicle Pin in the clavicle." This suggests a reliance on existing clinical outcomes data and expert consensus reflected in the existing literature for the predicate devices.
The sample size for the training set: N/A - This device is a physical implant; it does not involve machine learning or a "training set."
How the ground truth for the training set was established: N/A - Not applicable for this type of device.

Summary of the Basis of Substantial Equivalence

The core of the submission for the DePuy® Rockwood™ Clavicle Pin is its demonstration of substantial equivalence to previously marketed predicate devices. The key elements presented for this argument are:

Similar Design: The device is a trocar-pointed, threaded pin. A minor design difference (trocar point location) is highlighted as an advantage (medial or lateral insertion) that doesn't fundamentally change its function or raise new safety/effectiveness concerns compared to the predicates.
Similar Material: All compared devices are made of 316L Stainless Steel.
Similar Intended Use: All devices are intended for bone fixation of fractures, specifically for the clavicle (for the subject device) or generally for fractures (for the predicates). The use of predicate pins in clavicle fractures is supported by literature.
Similar Product Code: All devices fall under the same regulatory product code (87 JDW).

The provided table explicitly lists these similarities across the Rockwood Clavicle Pin and several predicate devices (DePuy Hagie & Modified Hagie Pins, DePuy Tibia Bolt, Onyx Medical Corp. & O'Tec Corp. Hagie Pins, Syntec-Trichung Knowles Pin). The FDA's clearance letter confirms their agreement with the substantial equivalence claim.

Summary

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JUL 14 1999

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR OF THIS 510(K):	DePuy, Inc.a Johnson & Johnson company700 Orthopaedic DriveP.O. Box 988Warsaw, Indiana 46581-0988
MANUFACTURER:	DePuy OrthoTech™1905 North McArthur DriveTracy, California 95376
510(K) CONTACT:	Sally FoustDePuy Orthopaedics, Inc.Sr. Regulatory Associate(219) 372-7455; FAX (219) 267-7098E-mail: sfoust2@dpyus.jnj.com
TRADE NAME:	DePuy® Rockwood™ Clavicle Pin
COMMON NAME:	Fracture Pin
CLASSIFICATION:	Class II per 888.3040, Smooth or threaded metallic bonefixation fastener
DEVICE CODE:	87 JDW
EQUIVALENT DEVICES:	DePuy Hagie & Modified Hagie Pins (pre-enactment)DePuy Tibia Bolt (pre-enactment)Onyx Medical Corp. (K903258) and O'Tec Corp. (K905347)Hagie PinsSyntec-Trichung Knowles Pin (K983757)

DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

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BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject Rockwood Clavicle Pin is similar in design, material and intended use to the pre-enactment DePuy Hagie/modified Hagie Pins. All are trocar pointed, threaded pins manufactured from stainless steel that are indicated for use as the bone fixation fastener in bone-to-bone fixation of fractures. One difference between the Rockwood Clavicle Pin and the Hagie Pins is that the Rockwood is designed with the trocar point located on the machine thread end of the pin whereas the pre-enactment Hagie Pins have the trocar point on the cancellous thread end of the pin. This design of the Rockwood Clavicle Pin provides the surgeon with a clavicle pin that can be inserted from either a medial or lateral direction whereas the pre-enactment Hagie pins can only be inserted from a lateral direction.

The subject Rockwood Clavicle Pin is also similar in design, material and intended use to the preenactment DePuy Tibia Bolt, FDA cleared Hagie Pins (K903258, K905347) and Syntec-Trichung Knowles Pin (K983757). All are trocar pointed, threaded pins manufactured from stainless steel that are indicated for use as the bone fixation faster in bone-to-bone fixation of fractures.

Published and unpublished literature documents the use of Hagie, modified Hagie, and Knowles pins in the treatment of clavicle fractures thereby justifying the use of the very similarly designed Rockwood Clavicle Pin in the clavicle.

Based on similarities of design, materials and intended use, DePuy believes that the subject Rockwood Clavicle Pin is substantially equivalent to pre-enactment devices and FDA cleared devices currently on the market.

	RockwoodClavicle Pin	Pre-EnactmentHagie &Modified HagiePin	Pre-EnactmentTibial Bolt	K903258 K905347Hagie Pins	K983757Syntec-TrichungKnowles Pin
Material	316L SS	316L SS	316L SS	316L SS	316L SS
Use	FX Fixation	FX Fixation	FX Fixation	FX Fixation	FX Fixation
Fracture Site	Clavicle	Multi	Tibia	Multi	Multi
Product Code	87 JDW	87 JDW	87 JDW	87 JDW	87 JDW
Threaded	Yes	Yes	Yes	Yes	Yes
Trocar Point	Yes	Yes	Yes	Yes	Yes
Sizes	5	2	1	NA	2
Nuts	2	1	2	NA	NA

The following table summarizes the similarities:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 1999

Ms. Sally Foust Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K991649

Trade Name: DePuy Rockwood Clavicle Pin Regulatory Class: II Product Code: JDW Dated: May 12, 1999 Received: May 13, 1999

Dear Ms. Foust:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Ms. Sally Foust

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known)_

Device Name: DePuy® Rockwood™ Clavicle Pin

Indications for Use:

The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or nc union of the clavicle.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use_ X (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991649

000002

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.