RETROGRADE PEDIATRIC NAIL

K980854 · Encore Orthopedics, Inc. · HTY · Aug 11, 1998 · Orthopedic

Device Facts

• Record ID: K980854
• Device Name: RETROGRADE PEDIATRIC NAIL
• Applicant: Encore Orthopedics, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.

Device Story

Retrograde Pediatric Nail is a metallic bone fixation device for pediatric fracture management. Device is implanted surgically to stabilize fractures of femur, tibia, and humerus. Design features include wrought Ti-6Al-4V construction, tapered diameter (4.0mm to 3.6mm), and fluted geometry for rotational stability. Proximal and distal ends are bent to provide 3-point fixation. One end is threaded for axial end screw or attachment cap. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

Bench testing only. Bending stiffness reported as 145 lb-in2 and torsional stiffness as 112 lb-in2.

Technological Characteristics

Material: Wrought Ti-6Al-4V (ASTM F136). Geometry: Tapered (4.0mm to 3.6mm), fluted, bent ends for 3-point fixation. Threaded end for screw/cap attachment. Mechanical properties: 145 lb-in2 bending stiffness, 112 lb-in2 torsional stiffness.

Indications for Use

Indicated for patients with fractures of the femur, tibia, and humerus requiring retrograde application, provided the growth plate is not compromised.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

K980854

Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500

Trade Name: Retrograde Pediatric Nail

Common Name: Femoral Nail

Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030.

The Retrograde Femoral Nail is made of wrought Ti-6Al-4V conforming to Description: ASTM F136. The diameter of the nail tapers from 4.0 mm to 3.6mm with 6 lengths ranging from 19 to 29 cm. Both the proximal and distal ends are bent to provide 3 point fixation. The entire nail is fluted for rotational stability. One end of the nail is threaded to allow for an axial end screw or smooth attachment cap.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include same indications for use and similar geometry.

Test Results: The nail is designed with a bending stiffness of 1451b-in2 and a torsional stiffness of 1121b-in2.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 11 1998

Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758

Re: K980854 Retrograde Pedicatric Nail Requlatory Class: II Product Code: HTY Dated: July 9, 1998 Received: July 13, 1998

Dear Ms. De Los Santos:

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. ਜ 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 requlatory 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 requlations.

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## Page 2 - Ms. Debbie De Los Santos

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,

Stephen Rhodes

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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510(k) Number (if known):

K980854

Retrograde Pediatric Nail Device Name: Indications For Use:

## Retrograde Pediatric Nail Indications For Use

The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.

(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

(Optional Format 1-2-96)

Stipt Rhodes

Division Sign Off Division of General Restorative Devices (980854 510(k) Number.