OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER

K990152 · Howmedica Osteonics Corp. · HSB · Mar 15, 1999 · Orthopedic

Device Facts

• Record ID: K990152
• Device Name: OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following: - . Open and closed femoral fractures. - . Pseudarthrosis and correction osteotomy. - . Pathologic fractures, impending pathologic fractures, and tumor resections. - . Supracondylar fractures, including those with intra-articular extension. - . Ipsilateral femur/tibia fractures. - . Fractures proximal to a total knee arthroplasty. - . Fractures distal to a hip implant. - Nonunions and malunions. .

Device Story

Osteo IC Retrograde/Antegrade Femoral Nail accessories (nut and washer) provide mechanical fixation for femoral fractures. Nut and washer components are used in conjunction with femoral nails and locking screws to stabilize bone segments. The washer sits between the locking screw head and bone surface; the T-shaped nut attaches to the distal end of the screw. These components are utilized by orthopedic surgeons in clinical settings during surgical fracture fixation procedures. The device provides structural support to facilitate bone healing and fracture stabilization.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: ASTM F136-96 titanium alloy (Ti6Al-4V) with Type II anodized coating. Washer: 1.2mm thick, 12mm diameter, 5.2mm through-hole. Nut: T-shaped, 12mm length, 7mm outer shaft diameter, 5.5mm inner shaft diameter, 12mm head diameter. Threaded inner shaft for locking screw accommodation. Provided sterile and non-sterile.

Indications for Use

Indicated for patients requiring long bone fracture fixation, specifically femoral fractures including open/closed fractures, pseudoarthrosis, correction osteotomy, pathologic fractures, tumor resections, supracondylar fractures, ipsilateral femur/tibia fractures, fractures proximal to total knee arthroplasty, fractures distal to hip implants, nonunions, and malunions.

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

• Richards Retrograde Nail

Submission Summary (Full Text)

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Summ

K990152

# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo IC Retrograde/Antegrade Femoral Nail - Accessories

| Submission Information | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>201-825-4900 |
| Contact Person: | Kate Sutton (or Marybeth Naughton)<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | January 12, 1999 |
| Device Identification | |
| Proprietary Name: | Osteo IC Retrograde/Antegrade Femoral Nail |
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod<br>21 CFR §888.3020 |

## Predicate Device Identification

The design and function of the Osteo IC Retrograde Femoral Nail nut and washer is substantially equivalent to the nut and washer of the predicate Richards Retrograde Nail. The subject and predicate systems offer femoral nails in varying lengths, and utilize a combination of locking screws, end caps, nuts, and washers.

## Device Description

The nut and washer for the Osteo IC Retrograde/Antegrade Femoral Nail are manufactured from ASTM F136-96 titanium alloy (Ti6Al-4V) and are anodized with a Type II coating process. The washer is 1.2mm thick, has a total diameter of 12mm, and a through-hole diameter of 5.2mm. The nut is T-shaped with an outer shaft diameter of 7mm, and inner shaft diameter of 5.5mm and a total length of 12mm. The head of the nut had a diameter of 12mm. The inner shaft of the nut is threaded in order to accommodate the threads of a locking screw. The washer is placed between the head of the locking screw and the bone surface. The nut is placed on the distal end of the screw. The 7mm diameter shaft of the nut sits below the surface of the bone, and the rounded 12mm diameter head of the nut will sit on the surface of the bone. All components of the Osteo IC Retrograde Femoral Nail are provided both sterile and non-sterile.

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# Intended Use

The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur/tibia fractures
- . Fractures proximal to a total knee arthroplasty
- Fractures distal to a hip implant
- . Nonunions and malunions

## Statement of Technological Comparison

The subject Osteo IC Retrograde Femoral Nail nut and washer are substantially equivalent in design and intended use to the predicate nut and washer offered by Richards.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1090

Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K990152 Re: . Osteo IC Retrograde/Antegrade Femoral Nail - Accessories Requlatory Class: II Product Code: HSB Dated: January 12, 1999 Received: January 19, 1999

Dear Ms. Staub:

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, qood 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 Requlations, Title 21, Parts 800 to 895. A 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 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 requlations.

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Page 2 - Ms. Elizabeth A. Staub

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.

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): K 99015 2

Device Name: Osteo IC Retrograde/Antegrade Femoral Nail - Accessories

Indications For Use:

The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

- . Open and closed femoral fractures.
- . Pseudarthrosis and correction osteotomy.
- . Pathologic fractures, impending pathologic fractures, and tumor resections.
- . Supracondylar fractures, including those with intra-articular extension.
- . Ipsilateral femur/tibia fractures.
- . Fractures proximal to a total knee arthroplasty.
- . Fractures distal to a hip implant.
- Nonunions and malunions. .

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

Concurrence of CDRH, Office of Device Eva

vice Evaluation (ODE)

(Division Sign-Off) √
Division of General Restorative Devices
510(k) Number K990152

Prescription Use_ X

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)