GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

K083648 · Efratgo, Ltd. HI Tech Bio-Surgical · HSB · May 14, 2009 · Orthopedic

Device Facts

• Record ID: K083648
• Device Name: GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
• Applicant: Efratgo, Ltd. HI Tech Bio-Surgical
• Product Code: HSB · Orthopedic
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.

Device Story

The Gotfried PH (Physiological Hip) Nail is an intramedullary fixation device designed for surgical management of proximal femur fractures. The system consists of an intramedullary nail, two proximal dynamic femoral neck screws, and up to two distal locking bolts. It is used by orthopedic surgeons in a clinical/OR setting to stabilize fractured bone segments. The device functions as an internal fixation implant to maintain alignment and support healing of the femur. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons.

Technological Characteristics

Constructed of stainless steel. Intramedullary nail design incorporating two proximal dynamic femoral neck screws and up to two distal locking bolts. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients requiring stabilization and fixation of proximal femur fractures, including trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures.

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

• Smith & Nephew Intramedullary Hip Screw (K040656)
• Stryker Gamma3 Locking Nail (K043431)
• Gotfried Physiological Hip (PH) Nail (K043233)

Submission Summary (Full Text)

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K083648

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## 510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

MAY 14 2009

- Submitter Efratgo Ltd. Hi Tech Bio-Surgical 1. Address: 49 Derech Acco Ave. Kiryat Motzkin Israel 26736
Phone: [phone]

Contact

Person: Yechiel Gotfried, MD

Date: December 4, 2008

- 2. Device & Gotfried PH (Physiological Hip) Nail Classification Device: Rod, Fixation, Intramedullary, and Accessories Name:
- 3. Predicate K040656- Smith & Nephew Intramedullary Hip Screw Devices: K043431- Stryker Gamma3 Locking Nail K043233- Gotfried Physiological Hip (PH) Nail
- 4. Description: The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and up to two distal locking bolts.
- The Gotfried PH (Physiological Hip) Nail is intended for 5. Intended Use: fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric). subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.
- 6. In terms of technology, the Gotfried PH (Physiological Hip) Nail Comparison of is substantially equivalent to its predicate devices. It is Technological Characteristics: constructed of stainless steel and incorporates the same orthopedic design principles and components as its predicate devices. Its dimensions and the majority of tolerances are within the range that has been previously determined to be substantially equivalent by the FDA.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Efratgo Ltd. Hi Tech Bio-Surgical % MedicSense Mr. George J. Hattub Senior Staff Consultant 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K083648

Trade/Device Name: The Gotfried PH (Physiological Hip) Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 28, 2009 Received: May 1, 2009

Dear Mr. Hattub:

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 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 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 Mr. George J. Hattub

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 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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K083648

## Indications for Use

510(k) Number (if known):

Device Name: The Gotfried PH (Physiological Hip) Nail

Indications For Use: The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.

Prescription Use __ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonetu
(Division Sign Off)

(DWision Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083648