OSTEO I-C HUMERAL NAIL SYSTEM

K981309 · Osteonics Corp. · HSB · Jun 22, 1998 · Orthopedic

Device Facts

• Record ID: K981309
• Device Name: OSTEO I-C HUMERAL NAIL SYSTEM
• Applicant: Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo I-C Humeral Nail System is indicated for single-use in the humeral shaft to address the following indications: fractures of the humeral shaft, non-unions, malalignments, pathologic fractures, and impending pathologic fractures. The use of the Osteo I-C humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures. The use of this system is indicated for diagonal and short oblique fractures of the humeral diaphysis as well as fractures of the metaphyseal and some comminuted humeral fractures. The Osteo I-C Humeral Nail System is intended for single use only.

Device Story

The Osteo I-C Humeral Nail System is an orthopedic implant system designed for the alignment and stabilization of humeral fractures. The system consists of a cylindrical intramedullary nail and associated hardware, including a locking screw, a compression screw, and a humerus protection screw. The device is implanted by a surgeon in a clinical or hospital setting to secure bone fragments. By providing internal fixation, the system aids in the stabilization of the humeral diaphysis and metaphyseal regions, facilitating bone healing and restoring structural integrity in cases of trauma or pathology. The system is intended for single-use only.

Clinical Evidence

No clinical data provided; substantial equivalence established through comparison to predicate devices.

Technological Characteristics

Intramedullary fixation rod system consisting of a cylindrical nail and various screws (locking, compression, protection). Designed for single-use. Materials and design are stated to be substantially equivalent to predicate systems.

Indications for Use

Indicated for patients with humeral shaft fractures, non-unions, malalignments, pathologic fractures, and impending pathologic fractures. Includes diagonal, short oblique, metaphyseal, and comminuted humeral fractures. For single-use only.

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

• Biomet Uniflex™ Humeral Nail System
• Synthes Titanium Solid Humeral Nail

Submission Summary (Full Text)

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JUN 22 1998

(

K98 1309

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteo I-C Humeral Nail System

#### Submission Information:

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

Contact Person:

Osteonics Corporation 59 Route 17 Allendale NJ 07401-1677

Marybeth Naughton Regulatory Affairs Team Member

#### Date of Summary Preparation:

April 6, 1998

### Device Identification

| Proprietary Name: | Osteo I-C Humeral Nail System<br>Includes the following components:<br>-Osteo I-C Humeral Nail<br>-Osteo I-C Humeral Nail Locking Screw<br>-Osteo I-C Humeral Nail Compression Screw<br>-Osteo I-C Nail Humerus Protection Screw |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Interlocking-Compression Humeral Nail System |
| Classification Name/Reference: | Intramedullary Fixation Rod<br>21 CFR §888.3020 |

#### Predicate Device Identification:

The components of the Osteo I-C Humeral Nail System are substantially equivalent to those of the Biomet Uniflex™ Humeral Nail System and the Synthes Titanium Solid Nail System.

#### Description of Devices:

The Osteo I-C Humeral Nail System consist of the Osteo I-C Humeral Nail, a cylindrical tube which is intended to aid in the alignment and stabilization of humeral fractures and associated components include the Osteo I-C Humeral Nail Locking Screw, the Osteo I-C Humeral Nail Compression Screw and the Osteo I-C Nail Humerus Protection Screw which are intended to secure the Osteo I-C Humeral Nail in place.

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## Intended Use:

The Osteo I-C Humeral Nail System is indicated for single-use in the humeral shaft to address the following indications: fractures of the humeral shaft, non-unions, malalignments, pathologic fractures, and impending pathologic fractures.

## Statement of Technological Comparison:

The design, materials, and intended use of the Osteo I-C Humeral Nail System are substantially equivalent to those of predicate Biomet Uniflex™ Humeral Nail System and the Synthes Titanium Solid Humeral Nail.

## Performance Data:

The comparison of the Osteo I-C Humeral Nail System to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 22 1998

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

Re: K981309 Osteo I-C Humeral Nail System Requlatory Class: II Product Code: HSB Dated: April 9, 1998 Received: April 10, 1998

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, 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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 regulation 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. 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., M.

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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Page I of 1

510(k) Number (if Known): K_98 130 9

Device Name: Osteo I-C Humeral Nail System

#### Indications For Use:

The use of the Osteo I-C humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures. The use of this system is indicated for diagonal and short oblique fractures of the humeral diaphysis as well as fractures of the metaphyseal and some comminuted humeral fractures. The Osteo I-C Humeral Nail System is intended for single use only.

## Indications:

- Fractures of the humeral shaft ♪
- Non-unions ﺑ
- Malalignments •
- Pathologic humeral fractures
- Impending pathologic humeral fractures

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

tocoleto

(Division Sign-Off)
Division of General Restorative Devices K98/309
510(k) Number.

Prescription Use
(per 21 CFR 801.109

OR

Over-The-Counter Use (Optional Format 1-2-96)