SYNTHES MULTILOC HUMERAL NAILING SYSTEM

K120807 · Synthes USA Products, LLC · HSB · Jul 6, 2012 · Orthopedic

Device Facts

• Record ID: K120807
• Device Name: SYNTHES MULTILOC HUMERAL NAILING SYSTEM
• Applicant: Synthes USA Products, LLC
• Product Code: HSB · Orthopedic
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation.

Device Story

The Synthes MultiLoc Humeral Nailing System is an intramedullary fixation device for humeral fractures. The system comprises cannulated metallic nails (7.0mm, 8.5mm, 10mm diameters; 180mm-315mm lengths), bone screws, and end cap accessories. Nails feature a proximal polymer inlay to enhance stability of 4.5mm MultiLoc locking screws, which can be interlocked with 3.5mm locking screws. The device is implanted into the medullary canal of the humerus by a surgeon to provide fracture fixation. The system provides mechanical stabilization of the bone segments to facilitate healing.

Clinical Evidence

Bench testing only. Testing performed per ASTM F 1264-03 included static and dynamic 4-point bending, torsional strength, and eccentric dynamic fatigue strength of the construct compared to predicate devices.

Technological Characteristics

Intramedullary fixation rod system. Materials: Metallic rods with proximal polymer inlay. Dimensions: 7.0mm, 8.5mm, 10mm diameters; 180mm-315mm lengths. Mechanical testing performed per ASTM F 1264-03.

Indications for Use

Indicated for patients with proximal humerus fractures (2-part surgical neck, 3-part, 4-part), proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

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 Cannulated Titanium Humeral Nail System (K033071)
• Synthes MultiLoc Proximal Humeral Nailing System (K103002)
• Synthes Angular Stable Locking System [ASLS] (K090241)
• Synthes 4.0mm and 5.0mm Locking Screws (K000089)
• Synthes 3.5mm Locking Screws (K000684)

Submission Summary (Full Text)

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K120807+"1/

| 3.0 | | 510(k) Summary |
|-----|--|----------------|
|-----|--|----------------|

| Sponsor: | Synthes (USA)<br>Rebecca G. Blank<br>Associate Regulatory Affairs Specialist<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone]<br>FAX [phone] | | JUL | 6 2012 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----|--------|
| Date Prepared: | March 15, 2012 | | | |
| Device Name: | Synthes MultiLoc Humeral Nailing System | | | |
| Classification: | Class II, §888.3020 – Intramedullary fixation rod<br>Product Code: HSB | | | |
| Predicate Device: | Synthes Cannulated Titanium Humeral Nail System | (K033071) | | |
| | Synthes MultiLoc Proximal Humeral Nailing System | (K103002) | | |
| | Synthes Angular Stable Locking System [ASLS] | (K090241) | | |
| | Synthes 4.0mm and 5.0mm Locking Screws | (K000089) | | |
| | Synthes 3.5mm Locking Screws | (K000684) | | |

Device Description:

Indications for use:

Substantial Equivalence: The Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation.

The system features intramedullary nail devices, as well as bone screws and end cap accessories. The nails are cannulated, offered in 7.0mm, 8.5mm, and 10mm diameters, and are available in 180mm -315mm in overall length. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc locking screws. Cleared 4.5mm MultiLoc Screws, used to facilitate the proximal locking of the nail construct, can be interlocked with cleared Synthes 3.5mm Locking Screws to enhance the stability of the construct.

The Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

Information presented supports substantial equivalence of the Synthes MultiLoc Humeral Nail to the predicate devices. The proposed system has the same indications for use, is similar in design, incorporates the same fundamental product technology and is composed of the same materials.

To additionally support substantial equivalence, testing comparing the bending strength of the subject and predicate devices was performed according to ASTM F 1264-03. In vitro bench testing included static and dynamic 4-point bending, torsional strength, and eccentric dynamic fatigue strength of the construct, compared to the predicate devices. Results support substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Synthes (USA) % Ms. Rebecca Blank Associate Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

6 2012 JUL

Re: K120807

Trade/Device Name: Synthes MultiLoc Humeral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 5, 2012 Received: June 6, 2012

Dear Ms. Blank:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Ms. Rebecca Blank

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2.0 Indications for Use

510(k) Number (if known):

Device Name: Synthes MultiLoc Humeral Nailing System

Indications for Use:

Humeral Nailing S ystem is indicated for fractures of the proximal The Synthes MultiLoc humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral frac tures with diaphy seal extension, di aphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Co unter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asof

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K120807 510(k) Number

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