G/K SFN AND STN LOCKING NAILS

K983358 · Howmedica, Inc. · HSB · Nov 18, 1998 · Orthopedic

Device Facts

• Record ID: K983358
• Device Name: G/K SFN AND STN LOCKING NAILS
• Applicant: Howmedica, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

Device Story

G/K Locking Nail System consists of solid femoral nails (SFN) and solid tibial nails (STN) for intramedullary fixation. Used for temporary stabilization of femur and tibia fractures, osteotomies, nonunions, and bone lengthening/shortening. Nails inserted via open or closed techniques, with or without reaming; can be locked statically or dynamically. Optional nail plug prevents tissue infiltration. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary rods fabricated from medical grade stainless steel. System includes solid femoral and tibial nails, cross-locking screws, and optional nail plugs. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients requiring temporary stabilization of femur and tibia fractures, osteotomies, malunions, nonunions, reconstruction, bone lengthening/shortening, prophylactic nailing of impending fractures, and fusions.

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 Universal Femoral Nail
• Synthes Unreamed Tibial Nail
• Orthofix Tibial Nailing System
• Orthofix Femoral Nailing System

Submission Summary (Full Text)

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K983358

510(k) Summary

| Proprietary Name: | G/K Locking Nail System |
|-------------------------------------|------------------------------------------------|
| Common Name: | IM Rod |
| Classification Name &<br>Reference: | Intramedullary Fixation Rod<br>21 CFR 888.3020 |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87HSB |
| For information contact: | Vivian Kelly |
| | Manager, Regulatory Affairs |
| | Howmedica Inc. |
| | 359 Veterans Boulevard |
| | Rutherford, NJ 07070 |
| | Telephone: [phone] |
| | Fax: [phone] |

Date prepared: September 23, 1998

The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

This G/K line extension includes solid femoral nails (SFN) and solid tibial nails STN) which may be used with cross-locking screws for intramedullary nailing of femoral and tibial fractures, respectively. The nails can be inserted with or without reaming using an opened or closed technique. They can be locked statically or dynamically. Also, there is an optional nail plug available to prevent tissue infiltration. All of the components are fabricated from medical grade stainless steel.

The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Synthes' Universal Femoral Nail and Unreamed Tibial Nail and Orthofix's Tibial Nailing and Femoral Nailing Systems.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

Ms. Vivian Kelly Manager, Requlatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

Re: K983358 G/K Locking Nail Line Extension Trade Name: Regulatory Class: II Product Code: нав September 23, 1998 Dated: Received: September 24, 1998

Dear Ms. Kelly:

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 The general controls provisions of the Act 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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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Page 2 - Ms. Vivian Kelly

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 requlation (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.

ia M. Witten, Ph.D., M.D. Cel 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):

Device Name: G/K Locking Nail System

Indications for Use:

The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, hone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_

(Optional Format 1-2-96)

(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K983358