K Number
K033071
Device Name
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
Manufacturer
Date Cleared
2003-11-05

(37 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include: - Diaphyseal fractures of the humeral shaft - Fractures of the proximal humerus - Proximal humeral fractures with diaphyseal extension - Impending pathologic fractures - Malunions and nonunions
Device Description
The Synthes Titanium Cannulated Humeral Nail System consists of cannulated titanium intramedullary rods, and end caps in a variety of sizes designed for treatment of various humeral fractures. A 2.0mm guide wire is used with the system.
More Information

Not Found

Not Found

No
The summary describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or AI/ML components.

Yes
The device is intended to aid in the alignment and stabilization of humeral fractures, which is a therapeutic purpose.

No

The device is described as a system of "cannulated titanium intramedullary rods, and end caps" intended to "aid in the alignment and stabilization of humeral fractures." This indicates it is a surgical implant used for treatment, not for diagnosing conditions.

No

The device description explicitly states it consists of physical components like intramedullary rods, end caps, and a guide wire, which are hardware.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description and Intended Use: The description clearly states that the Synthes Titanium Cannulated Humeral Nail System is a system of implants (rods and end caps) used to align and stabilize bone fractures within the body. This is a surgical implant, not a device that analyzes biological samples.

The information provided describes a device used in vivo (within the living body) for structural support and stabilization, which is the opposite of an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include:

  • Diaphyseal fractures of the humeral shaft
  • Fractures of the proximal humerus
  • Proximal humeral fractures with diaphyseal extension
  • Impending pathologic fractures
  • Malunions and nonunions

Product codes

JDS

Device Description

The Synthes Titanium Cannulated Humeral Nail System consists of cannulated titanium intramedullary rods, and end caps in a variety of sizes designed for treatment of various humeral fractures. A 2.0mm guide wire is used with the system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

humeral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.

0

NOV - 5 2003

03307/
page 1 of 1

3. Summary of Safety and Effectiveness Information [510(k) Summary]

| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Lisa M. Boyle
(610) 647-9700 |
| Name of the Device | Synthes Titanium Cannulated Humeral Nail System |
| Device Classification(s) | Class II, §888.3020 - Intramedullary Fixation Rod |
| Device Description | The Synthes Titanium Cannulated Humeral Nail System consists of
cannulated titanium intramedullary rods, and end caps in a variety of
sizes designed for treatment of various humeral fractures. A 2.0mm
guide wire is used with the system. |
| Indications | The Synthes Titanium Cannulated Humeral Nail System is intended to
aid in the alignment and stabilization of humeral fractures to include:
Diaphyseal fractures of the humeral shaft Fractures of the proximal humerus Proximal humeral fractures with diaphyseal extension Impending pathologic fractures Malunions and nonunions |
| Substantial Equivalence | Documentation is provided which demonstrated the Synthes Titanium
Cannulated Humeral Nail System to be substantially equivalent to
other legally marketed devices.

The term "substantial equivalence" as used in this 510(k) notification
is limited to the definition of substantial equivalence found in the
Federal Food, Drug and Cosmetic Act, as amended and as applied
under 21CFR 807, Subpart E under which a device can be marketed
without premarket approval or reclassification. A determination of
substantial equivalency under this notification is not intended to have
any bearing whatsoever on the resolution of patent infringement suits
or any other patent matters. No statements related to, or in support of
substantial equivalence herein shall be construed as an admission
against interest under the US Patent Laws or their application by the
courts. |
| Material | Titanium Alloy |

.

1

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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K033071

Trade/Device Name: Synthes (USA) Titanium Cannulated Humeral Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDS Dated: September 26, 2003 Received: September 29, 2003

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

2

Page 2 – Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

2. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

K03307/

Synthes (USA) Titanium Cannulated Humeral Nail System

The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include:

  • Diaphyseal fractures of the humeral shaft ●
  • Fractures of the proximal humerus ●
  • . Proximal humeral fractures with diaphyseal extension
  • . Impending pathologic fractures
  • Malunions and nonunions .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
Mark A. Mulhern

Division Sign-Off) (Division of General, Restorative Divisiourological Devices

10(k) Number -

Synthes(USA)