SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION

K082148 · Synthes (Usa) · HSB · Aug 11, 2008 · Orthopedic

Device Facts

• Record ID: K082148
• Device Name: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Aug 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

Device Story

The Synthes Elastic Intramedullary Nail (EIN) End Cap is a mechanical accessory for the EIN System. It is inserted over the external portion of the nail and threaded into cancellous bone in an oblique orientation. The device is used by surgeons in a clinical/OR setting to secure the nail within the bone. It provides mechanical fixation for fractures in pediatric, small-stature, or narrow-canal patients. No software or electronic components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical orthopedic implant; end cap threaded into cancellous bone. Materials and design are consistent with the predicate EIN system. No software, electronics, or energy sources.

Indications for Use

Indicated for fixation of diaphyseal, metaphyseal, and epiphyseal fractures in upper extremities (all patients) and lower extremities (pediatric or small-stature patients), and fixation of small long bones (carpal/tarsal). Used where canal is narrow or implant flexibility is required to avoid bone growth plate disruption.

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

• Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System (K081452)
• Synthes Elastic Intramedullary Nail (EIN) End Cap (K053105)

Submission Summary (Full Text)

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## AUG 11 2008

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| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| | Device Name: | Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line<br>Extension |
| | Classification: | 21 CFR 888.3020: Intramedullary fixation rod (HSB) |
| | Predicate Devices: | Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System<br>(K081452)<br>Synthes Elastic Intramedullary Nail (EIN) End Cap (K053105) |
| | Device Description: | The Synthes Elastic Intramedullary Nail (EIN) End Cap is used<br>with the Synthes Elastic Intramedullary Nail (EIN) System. The<br>end cap is inserted over the external portion of the nail and<br>threaded into the cancellous bone in an oblique orientation. |
| | Intended Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicated<br>for fixation of diaphyseal fractures where the canal is narrow or<br>flexibility of the implant is paramount. This includes upper<br>extremity fractures in all patients and lower extremity fractures in<br>pediatric or small-stature patients. This system is also intended to<br>treat metaphyseal and epiphyseal fractures, such as radial neck<br>fractures and is intended for fixation of small long bones, such as<br>carpal and tarsal bones. In pediatric applications, the flexibility of<br>the EIN allows it to be inserted at a point which avoids disruption<br>to the bone growth plate. |
| | Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 1 2008

Synthes (USA) % Ms. Jill R. Sherman Regulatory Affairs/Compliance Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Rc: K082148

Trade/Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 29, 2008 Received: July 30, 2008

Dear Ms. Sherman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 – Ms. Jill R. Sherman

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark W. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

KO82148

Device Name:

2.0

Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension

Indications for Use:

The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Mark Concurrence of DRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K08