GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM

K983814 · Efratgo, Ltd. HI Tech Bio-Surgical · JDO · Jan 14, 1999 · Orthopedic

Device Facts

• Record ID: K983814
• Device Name: GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
• Applicant: Efratgo, Ltd. HI Tech Bio-Surgical
• Product Code: JDO · Orthopedic
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

Device Story

The GOTFRIED PC.C.P is a percutaneous compression plating system for hip fracture fixation. It consists of a plate and screw assembly made of stainless steel. The system utilizes dynamic femoral neck screws (90-140 mm length, 9.3 mm barrel diameter, 6.4 mm shaft diameter) and 4.5 mm cortical screws. The device is used by orthopedic surgeons in a clinical/surgical setting to stabilize proximal femoral fractures. By providing mechanical fixation, the device facilitates bone healing and restores structural integrity to the hip joint, potentially improving patient mobility and reducing pain associated with fractures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by biomechanical bench testing comparing bending stiffness, torsional stiffness, and ultimate loads to failure against predicate systems.

Technological Characteristics

Stainless steel plate and screw system. Includes two dynamic femoral neck screws and three cortical screws. Percutaneous application. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients with stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Proximal Femoral Nail (PFN) (K970097)
• Zimmer Versa-Fx Femoral Fixation System (K954555)

Submission Summary (Full Text)

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JAN 1 4 1999

### 510(k) Summary

# GOTFRIED PC.C.P PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES

510(k) Number K983814

#### Submitter's Name:

EFRATGO LTD. HI TECH BIO-SURGICAL 10 Ben Gurion St. Kyriat Bialik 27000, Israel Tel: [phone] Fax: [phone]

## Contact Person:

Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: [phone] Fax: [phone]

## Trade Name:

# GOTFRIED PC.C.P (PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES)

## Classification Name:

Proximal Femoral Fixation Implant Device

# Classification:

The FDA has classified these devices in Class II (product code 87 JDO). Proximal femoral fixation implant devices are reviewed by the Orthopedic and Rehabilitation Devices Branch.

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#### Intended Use:

The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

#### Device Description:

The GOTFRIED PC.C.P system is a plate and screw system, made of stainless steel, which utilizes dynamic femoral neck screws. The plate accepts two neck screws (length ranging from 90 mm to 140 mm) having barrel (sleeve) diameter of 9.3 mm and shaft diameter of 6.4 mm, and three 4.5 mm cortical screws (length ranging from 31 to 43 mm).

#### Substantial Equivalence:

The GOTFRIED PC.C.P is substantially equivalent to the Synthes Proximal Femoral Nail (PFN), cleared under K970097, and the Zimmer Versa-Fx Femoral Fixation System, cleared under K954555, in terms of intended use, material and design. Moreover, based on biomechanical test results, the biomechanical characteristic of the GOTFRIED PC.C.P is at least equivalent to other compression hip screw systems in terms of bending and torsional stiffness and ultimate loads to failure.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Representing Efratgo, Limited Hi Tech Bio-Surgical 555 13th Street, NW Washington, DC 20004-1109

K983814 Re: Gotfried Percutaneous Trade Name: Compression Plating System Regulatory Class: II Product Code: JDO Dated: October 28, 1998 Received: October 28, 1998

Dear Mr. Kahan:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ಕ್ಕಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Jonathan S. Kahan

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

**510(k) Number (if known):** K983814

Device Name:

GOTFRIED PC.C.P (PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES)

Indications for Use:

The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

Over the Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983814