OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL

K982601 · Osteonics Corp. · HSB · Sep 14, 1998 · Orthopedic

Device Facts

• Record ID: K982601
• Device Name: OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
• Applicant: Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Sep 14, 1998
• 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 is 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

The Osteo IC Retrograde/Antegrade Femoral Nail is a cylindrical, cannulated titanium alloy intramedullary rod designed for femoral fracture fixation. The device is slightly bowed to match femoral anatomy and is available in various lengths (240mm-500mm) and diameters (9mm-15mm). It is implanted by a surgeon via either antegrade or retrograde surgical approach. The system includes auxiliary components such as locking screws, compression screws, end caps, and end screws to secure the nail within the femoral canal. The device provides mechanical stabilization of the femur to facilitate bone healing. It is intended for use in clinical settings by orthopedic surgeons.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Titanium alloy. Form factor: Cylindrical, cannulated, bowed intramedullary nail. Dimensions: 240mm-500mm length, 9mm-15mm diameter. Components: Locking screws, compression screws, end caps, end screws. Surgical approach: Antegrade or retrograde.

Indications for Use

Indicated for patients requiring femoral fracture fixation, including open/closed fractures, pseudoarthrosis, correction osteotomy, pathologic fractures, tumor resections, supracondylar fractures, ipsilateral femur/tibia fractures, periprosthetic fractures (proximal to total knee or distal to hip), 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

• Synthes Titanium Distal Femoral System
• Synthes Titanium Unreamed Femoral Nail System
• AIM Titanium Femoral Nail (ACE Medical)
• Richards Retrograde Nail

Submission Summary (Full Text)

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SEP 1 4 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS Osteo IC Retrograde/Antegrade Femoral Nail

#### Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

> 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Osteonics Corporation

July 22, 1998

Kate Sutton Regulatory Affairs Specialist

Date Summary Prepared:

Device Identification

Proprietary Name:

Contact Person:

Common Name:

Classification Name and Reference:

Osteo IC Retrograde/Antegrade Femoral Nail

Intramedullary Nail, Femoral Nail

Intramedullary Fixation Rod 21 CFR §888.3020

#### Predicate Device Identification

The design and function of the Osteo IC Retrograde/Antegrade Femoral Nail is substantially equivalent to that of the predicate Synthes Titanium Distal Femoral System, the predicate Synthes Titanium Unreamed Femoral Nail System. the predicate AIM Titanium Femoral Nail, manufactured by ACE Medical, and 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, the combination of which varies depending on which manufacturer's product is being used.

#### Device Description

The Osteo IC Retrograde/Antegrade Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Osteo IC Retrograde/Antegrade Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Osteo IC Retrograde / Antegrade Femoral Nail is available in three versions, each in lengths from 240mm to 500mm in 20mm increments, and in diameters from ø9mm to ø15mm in 1mm increments. A compression screw and locking screw may be used with the Femoral Nail. An end screw and an

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end cap are also available for use with the Femoral Nail. An end cap or end screw is used if a compression screw has not been used. The end screw is used when the Femoral Nail has been inserted via a retrograde approach. The end cap is used when the Femoral Nail has been inserted via an antegrade approach.

### Intended Use

The Osteo IC Retrograde/Antegrade Femoral Nail is 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 turnor 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/Antegrade Femoral Nail components are substantially equivalent in design and intended use to the predicate devices offered by Synthes, ACE Medical, and Richards.

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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 a bird in flight, composed of three human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Ms. Kate Sutton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K982601 Osteo IC Retrograd/Antegarde Femoral Nail Regulatory Class: II Product Code: HSB Dated: July 22, 1998 Received: July 27, 1998

Dear Ms. Sutton:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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. Kate Sutton

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.

Ph.D., M.D. Celia M. Witten, 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_98 260 \

Device Name: Osteo IC Retrograde/Antegrade Femoral Nail

Indications For Use:

The Osteo IC Retrograde/Antegrade Femoral Nail is 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 Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Decease

Division of General Restorative Device 510(k) Number.