GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

K043233 · Efratgo, Ltd. HI Tech Bio-Surgical · HSB · Feb 1, 2005 · Orthopedic

Device Facts

• Record ID: K043233
• Device Name: GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
• Applicant: Efratgo, Ltd. HI Tech Bio-Surgical
• Product Code: HSB · Orthopedic
• Decision Date: Feb 1, 2005
• 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, and base of neck fractures of the proximal femur.

Device Story

The Gotfried PH (Physiological Hip) Nail is an intramedullary nail system designed for the surgical management of proximal femoral fractures. The device consists of a nail, two proximal dynamic femoral neck screws, and two distal locking bolts. It is implanted by a surgeon in an operating room setting to provide internal fixation and stabilization of fractured bone segments. By utilizing dynamic screws and locking bolts, the device facilitates fracture management, potentially promoting healing and restoring structural integrity to the proximal femur. The device is intended for prescription use only.

Clinical Evidence

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

Technological Characteristics

Intramedullary nail system constructed of stainless steel. Incorporates two proximal dynamic femoral neck screws and two distal locking bolts. Design utilizes standard orthopedic fixation principles for proximal femoral fractures.

Indications for Use

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

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

• Gotfried Percutaneous Compression Plating System (K983814)
• Synthes PFN Proximal Femoral Nail (K970097)
• Howmedica (Stryker) Gamma Locking Nail (K034002)

Submission Summary (Full Text)

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## 510(k) Summary

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

- Efratgo Ltd. Hi Tech Bio-Surgical Submitter 1. 10 Ben Gurion Street Address: Kyriat Bialik, Israel 27000 972-4-870-6628 Phone: Contact Yechiel Gotfried, MD Person: November 15, 2004 Date: Gotfried PH (Physiological Hip) Nail Device & 2. Device: Fixation, Proximal, Femoral Implant Classification Name: Gotfried Percutaneous Compression Plating System K983814 3. Predicate Synthes PFN Proximal Femoral Nail K970097 Devices: Howmedica (Stryker) Gamma Locking Nail K034002 The Gotfried PH (Physiological Hip) Nail is an intramedullary Description: ব nail which utilizes two proximal dynamic femoral neck screws and 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, and base of neck fractures of the proximal femur. In terms of technology, the Gotfried PH (Physiological Hip) Nail 6. Comparison of is substantially equivalent to its predicate devices. It is Technological constructed of stainless steel and incorporates the same Characteristics: 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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Public Health Service

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Efratgo, Ltd. C/o Mr. George J. Hattub, RAC & CQE Senior Staff Consultant MedicSense, Clinical and Regulatory Affairs 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K043233

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: November 15, 2004 Received: November 22, 2004

Dear Mr. Hattub:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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 If your device to such additional controls. Existing major regulations affecting your device can mar be subject to observe a 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 I lease be devised alle i Brinination that your device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must or any I casual batates and regirements, 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 - Mr. George J. Hattub, RAC & CQE

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls ought maing of substantial equivalence of your device to a legally premarket notificated wice 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 It you acon office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Other general 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,

Sincerely yours,

Mark N Wilkerson

Celia M. Witten, Ph.D., M.D. 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

043233 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 management of Coch Thion, and management of trochanteric (intertrochanteric and borte stabliled.com, matteric, and base of neck fractures of the proximal femur.

Prescription Use In (Part 21 CFR 801 Subgart D) AND/OR

Over-The-Counter Use _ (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)

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

2- 510(k) Number K043233