ORTHOSORB RESORBABLE PINS

K111077 · DePuy Orthopaedics, Inc. · OVZ · Jul 12, 2011 · Orthopedic

Device Facts

• Record ID: K111077
• Device Name: ORTHOSORB RESORBABLE PINS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: OVZ · Orthopedic
• Decision Date: Jul 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.

Device Story

ORTHOSORB Resorbable Pins are orthopedic fixation devices used to stabilize small bony or chondral fragments. Pins are implanted by surgeons in clinical settings (e.g., OR) to provide mechanical fixation for fractures, osteotomies, or joint procedures. Device acts as a temporary internal support; material is resorbable, eliminating need for secondary removal surgery. Pins are MR Safe per ASTM F2503.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design and material characteristics to the predicate device.

Technological Characteristics

Material: poly-p-dioxanone. Dimensions: 1.3mm and 2.0mm diameters; 40mm and 50mm lengths. MR Safe per ASTM F2503. Mechanical fixation device.

Indications for Use

Indicated for fixation of small bony or chondral fragments in knee and hand (non-tension areas, e.g., osteochondritis dissecans, phalangeal/metacarpal fractures); fixation of inherently stable great toe osteotomies; intramedullary stability for lesser toe deformity joint arthroplasty; and supplemental support for finger joint fusion and digit replantation.

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

• ORTHOSORB Resorbable Pin (K901456)

Submission Summary (Full Text)

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510(k) Summary

| General Provisions | The name of the device is: | | | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | Proprietary Name Common or Usual Name ORTHOSORB® Resorbable Pins Pin, Fixation, Resorbable, Hard Tissue | | | | |
| Name of Predicate Devices | The device is substantially equivalent to the currently marketed ORTHOSORB Resorbable Pin, K901456. | | | | |
| Classification | Class II, Regulation Number 21 CFR 888.3040, Product Code OVZ | | | | |
| 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 ORTHOSORB 1.3mm and 2.0mm Resorbable Pins are made from poly-p-dioxanone and are available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths with their accompanying instrumentation. | | | | |
| Indications for Use | The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed. | | | | |
| Technological Characteristics | The technological characteristics of the ORTHOSORB Resorbable pins that are the subject of this submission remain unchanged from the predicate device in terms of design, material and performance. | | | | |

JUL 12 2011 K111077
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Summary of Substantial Equivalence

The ORTHOSORB Resorbable pins that are the subject of this submission are equivalent to the predicate device. The technological characteristics are identical. Based on material, the pins are considered MR Safe as defined in ASTM F2503.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

JUL 1 2 2011

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño 700 Orthopaedic Drive Warsaw, IN 46581-0988

Re: K111077

Trade/Device Name: ORTHOSORB Resorbable Pin Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: OVZ Dated: April 14, 2011 Received: April 18, 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 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. 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 mav 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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## Page 2 - Ms. Suzana Otaño

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/CDRH/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 number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

E. Keith

A 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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510(k) Number:

## K111077

Device Name:

## ORTHOSORB Resorbable Pin

## Indications For Use:

The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.

Prescription Use A (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)

Page 1 of 1

for M. Meukerm

(Division Sigh-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111077