OSTEO 9MM IC TIBIAL NAIL

K984353 · Osteonics Corp. · HSB · Dec 16, 1998 · Orthopedic

Device Facts

• Record ID: K984353
• Device Name: OSTEO 9MM IC TIBIAL NAIL
• Applicant: Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: - Static and compression locking - Transverse and short oblique fractures - Pseudarthrosis - Correction osteotomies

Device Story

Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel intramedullary nail designed for alignment and stabilization of tibial fractures. Device features three external longitudinal grooves for bending resistance and torsional stability; available in lengths 240mm-420mm. Implanted with proximal/distal locking screws and optional end cap using manual surgical instruments. Modified design includes increased wall thickness, reduced distal cannulation diameter, extended proximal tapered portion, and proximal anterior chamfer to reduce patellar tendon irritation. Used by orthopedic surgeons in clinical settings to maintain limb length and resist rotation of fracture segments, facilitating bone healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Stainless steel. Design: Cylindrical, cannulated tube with three external longitudinal grooves. Dimensions: 9mm distal shaft diameter; 240mm-420mm lengths. Features: Proximal portion tapered at 2° angle; 10° chamfer on proximal anterior end. Energy source: None (manual surgical instrument). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring long bone fracture fixation, specifically tibial fracture fixation, including static and compression locking, transverse and short oblique fractures, pseudarthrosis, and correction osteotomies.

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

• Osteo 9mm IC Tibial Nail (K984353)

Submission Summary (Full Text)

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K984353

# SPECIAL 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo 9mm IC Tibial Nail

#### Submission Information

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

Contact Person:

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

Kate Sutton Regulatory Affairs Specialist

Date Summary Prepared:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

December 1, 1998

Osteo 9mm IC Tibial Nail

Intramedullary Nail, Tibial Nail

Intramedullary Fixation Rod 21 CFR §888.3020

### Predicate Device Identification

The design and function of the Osteo 9mm IC Tibial Nail is substantially equivalent to that of the predicate Osteo 9mm IC Tibial Nail. The subject and predicate systems offer tibial nails in varying lengths, and utilize compression screws, a locking screw, and an end cap.

### Device Description

The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.

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The following changes have been made to the modified Tibial Nail.

- The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction 1) in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
- The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 2) 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
- 3) In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.

# Intended Use

The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

- 0 Static and compression locking
- # Transverse and short oblique fractures
- Pseudarthrosis
- Correction osteotomies থা

## Statement of Technological Comparison

The subject modified Osteo 9mm IC Tibial Nail components are substantially equivalent in design and intended use to the predicate unmodified Osteo 9mm IC Tibial Nail components.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

DEC I 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K984353 Osteo 9mm IC Tibial Nail Trade Name: Regulatory Class: II Product Code: HSB December 1, 1998 Dated: December 7, 1998 Received:

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, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 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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#### 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,

Colin M. Whitton, Ph.D.

a 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): K984353

Device Name: Osteo 9mm IC Tibial Nail

Indications For Use:

The indications for the use of the Osteo 9mm IC Tibial Nail remain unchanged and are as follows:

- . Static and compression locking
- Transverse and short oblique fractures .
- Pseudarthrosis
- Correction osteotomies ●

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Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984353

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)