HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM

K100238 · DePuy Orthopaedics, Inc. · HSB · May 11, 2010 · Orthopedic

Device Facts

• Record ID: K100238
• Device Name: HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

Device Story

Intramedullary fixation system consisting of titanium alloy nail, lag screw, distal screws, and end cap; used for stabilization of proximal femoral fractures. Implanted by orthopedic surgeons in clinical/surgical settings. Device provides mechanical support to fractured bone segments to facilitate healing. Output is physical fixation of bone; clinical decision-making based on radiographic assessment of fracture type and patient bone health. Benefits include stabilization of complex fractures and restoration of structural integrity.

Clinical Evidence

Bench testing only. Cyclical mechanical testing performed to compare maximum load to failure against predicate devices.

Technological Characteristics

Titanium alloy intramedullary nail system. Includes lag screw, distal screws, and end cap. Available in 125° and 130° angles, 9-15mm distal diameters, and 180-460mm lengths. Mechanical fixation device.

Indications for Use

Indicated for patients with stable/unstable proximal femur fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures; non-union; malunion; tumor resections; shaft fractures; pathologic fractures in osteoporotic bone; impending pathological fractures; ipsilateral femoral fractures; and revision procedures.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Trochanteric Nail System (K042325)
• Gamma3 Nail System (K043431)

Submission Summary (Full Text)

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K1002-38

## SECTION 5 - 510(K) SUMMARY

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581 | MAY 11 2010 |
|---------------|------------------------------------------------------------------------------------------------|-------------|
| | Phone: [phone]<br>Fax: [phone]<br>US representative for Medos International SARL | |

Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs

January 22, 2010 Date Prepared:

Hip Fracture Nail System Proprietary Name:

Intramedullary Fixation Rod Common Name:

Rod, Fixation, Intramedullary and accessories (21 CFR § Classification Name: 888.3020)

- The Hip Fracture Nail System is substantially equivalent to Predicate Devices: currently marketed devices: Trochanteric Nail System (K042325) and Gamma3 Nail System (K043431).
Device Description: The Hip Fracture Nail System consists of an intramedullary nail, lag screw, distal screws, end cap and optional antirotation screw all manufactured from titanium allov and used to treat fractures in the proximal portion of the femur. The system offers 125° and 130° angle nails with 9-15mm distal diameters and a 180-460mm length range.

Indications for Use: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas. impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions, malunions, revision procedures and turnor resections.

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Hip Fracture Nail System Traditional 510(k) DePuy Orthopaedics, Inc. for Medos International SARL

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| Technological<br>Characteristics: | The technological characteristics of the Hip Fracture Nail<br>System are similar to the predicate devices including design<br>and material. The Hip Fracture Nail system and predicate<br>systems are manufactured from titanium alloy. Dimensional<br>characteristics are similar among the systems including<br>proximal and distal nail diameters, nail angles and lengths.<br>In addition to the material, the screws are similarly<br>comparable in major and minor OD and length. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence: | The Hip Fracture Nail System is substantially equivalent to<br>currently marketed devices as demonstrated with pre-clinical<br>data. Cyclical testing demonstrated that the new Hip<br>Fracture Nail System achieved higher maximum loads prior<br>to failure when compared to both predicate devices<br>successfully meeting the pre-defined acceptance criteria. No<br>new issues of safety or efficacy have been raised. |

pizfer

Hip Fracture Nail System Traditional 510(K)
DePuy Orthopaedics, Inc. for Medos International SARL

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

MAY 1 1 2010

Re: K100238

Trade/Device Name: Hip Fracture Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedu!lary fixation rod Regulatory Class: II Product Code: HSB Dated: April 28, 2010 Received: April 29, 2010

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, listing 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 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

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## Page 2 - Ms. Suzana Otaño

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 vours.

Clara Bielup

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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## SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

K100238

Hip Fracture Nail System Device Name:

## Indications For Use:

The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures iractures, intertroons of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

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)

Anita for nym
(Division Sign-Off)

Division of Surgical. Othopedic. and Restorative Devices

510(k) Number K100238

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Hip Fracture Nail System Traditional 510(k) DePuy Orthopaedics, Inc. for Medos International SARL