SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)

K992348 · Synthes (Usa) · JDS · Sep 23, 1999 · Orthopedic

Device Facts

• Record ID: K992348
• Device Name: SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
• Applicant: Synthes (Usa)
• Product Code: JDS · Orthopedic
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

Device Story

Synthes Spiral Blade for Humeral Nail (SBHN) is an orthopedic implant used in conjunction with the Synthes Solid Humeral Nail to stabilize humeral fractures. The device features a cannulated design with a self-cutting blade tip and peripheral suture holes. It is inserted into the humerus during surgical procedures performed by orthopedic surgeons. A locking end cap secures the blade within the nail. The device provides mechanical fixation to support bone healing and fracture stabilization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; cannulated design; self-cutting blade tip; includes suture holes; lengths 34 mm to 54 mm; utilizes locking end cap for securement; mechanical fixation principle.

Indications for Use

Indicated for the stabilization of humeral fractures in patients requiring intramedullary fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Unreamed Humeral Nail (a.k.a. Solid Humeral Nail)

Submission Summary (Full Text)

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K992348

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| Attachment VI: | Summary of Safety and Effectiveness Information<br>[510(k) Summary] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Spiral Blade for Humeral Nail (SBHN) |
| COMMON OR USUAL<br>NAME | Intramedullary fixation rod;<br>Smooth or threaded metallic bone fixation fastener |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 888.3020 and 888.3040 |
| PREDICATE DEVICE: | Synthes Unreamed Humeral Nail (a.k.a. Solid Humeral Nail) |
| DESCRIPTION: | Synthes Spiral Blade is used in conjunction with Synthes<br>Solid Humeral Nail. The Synthes SBHN has a<br>self-cutting blade tip, is cannulated, has suture holes located<br>around periphery of blade head, and is available in lengths<br>ranging from 34 mm to 54 mm. A Locking End Cap is used to<br>lock the Spiral Blade in place. |
| INTENDED USE: | Synthes Spiral Blade for Humeral Nail is intended to stabilize<br>fractures of the humerus. |

Attachment VI:

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Spiral Blade for Humeral Nail

Synthes (USA)

CONFIDENTIAL

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P. O. Box 1766 Paoli, Pennsylvania 19301

Re: K992348

> Trade Name: Synthes Spiral Blade for Humeral Nail Regulatory Class: II Product Code: JDS Dated: July 13, 1999 Received: July 14, 1999

Dear Ms. Musgnung:

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 of the Act. The general controls provisions 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 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 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 regulations.

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## Page 2 - Ms. Sheri L. Musgnung

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.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 2.0

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510(k) Number (if known):
K992348

Synthes Spiral Blade for Humeral Nail Device Name:

Indications For Use:

Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

tcoell

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992348

CONFIDENTIAL