DEPUY ROCKWOOD CLAVICLE PIN

K991649 · Depuy, Inc. · JDW · Jul 14, 1999 · Orthopedic

Device Facts

• Record ID: K991649
• Device Name: DEPUY ROCKWOOD CLAVICLE PIN
• Applicant: Depuy, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The DePuy Rockwood Clavicle Pin is a metallic bone fixation fastener used by orthopedic surgeons to stabilize clavicle fractures. The device consists of a stainless steel pin with machine threads on one end (featuring a trocar point) and cancellous threads on the other, provided pre-assembled with two locking nuts. During surgery, the pin is inserted into the bone; one nut is tightened to compress the fracture site and prevent migration, while the second nut locks the first in place. The trocar point design allows for either medial or lateral insertion. By providing rigid internal fixation, the device facilitates bone healing in acute fractures, mal-unions, or non-unions, potentially reducing recovery time and improving clinical outcomes for patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices, supported by literature documenting the use of similar pin designs in clavicle fracture treatment.

Technological Characteristics

Constructed from 316L stainless steel. Features a threaded pin design with a trocar point and two locking nuts. Available in four diameters (2.5, 3.0, 3.8, 4.5mm) and a single length (152mm). Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring surgical repair of acute clavicle fractures, mal-unions, or non-unions.

Regulatory Classification

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.

Predicate Devices

• DePuy Hagie & Modified Hagie Pins (pre-enactment)
• DePuy Tibia Bolt (pre-enactment)
• Onyx Medical Corp. (K903258)
• O'Tec Corp. (K905347)
• Syntec-Trichung Knowles Pin (K983757)

Submission Summary (Full Text)

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JUL 14 1999

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR OF THIS 510(K): | DePuy, Inc.<br>a Johnson & Johnson company<br>700 Orthopaedic Drive<br>P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy OrthoTech™<br>1905 North McArthur Drive<br>Tracy, California 95376 |
| 510(K) CONTACT: | Sally Foust<br>DePuy Orthopaedics, Inc.<br>Sr. Regulatory Associate<br>[phone]; FAX [phone]<br>E-mail: [e-mail] |
| TRADE NAME: | DePuy® Rockwood™ Clavicle Pin |
| COMMON NAME: | Fracture Pin |
| CLASSIFICATION: | Class II per 888.3040, Smooth or threaded metallic bone<br>fixation fastener |
| DEVICE CODE: | 87 JDW |
| EQUIVALENT DEVICES: | DePuy Hagie & Modified Hagie Pins (pre-enactment)<br>DePuy Tibia Bolt (pre-enactment)<br>Onyx Medical Corp. (K903258) and O'Tec Corp. (K905347)<br>Hagie Pins<br>Syntec-Trichung Knowles Pin (K983757) |

### DEVICE DESCRIPTION AND INTENDED USE:

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.

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.

| | Rockwood<br>Clavicle Pin | Pre-Enactment<br>Hagie &<br>Modified Hagie<br>Pin | Pre-<br>Enactment<br>Tibial Bolt | K903258<br>K905347<br>Hagie Pins | K983757<br>Syntec-<br>Trichung<br>Knowles 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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