(112 days)
Not Found
No
The description focuses on the mechanical components and intended use for fracture fixation, with no mention of AI or ML.
No.
The device is a metallic implant used for fracture fixation, not for treating or preventing disease.
No
Explanation: The device is a system of metallic rods and accessories for fracture fixation in the humerus, not for diagnosing conditions.
No
The device description clearly states it consists of metallic rods and accessories intended for implantation, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures in the humerus (a bone). This is a surgical procedure, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of metallic rods, screws, and accessories for implantation. These are physical implants used to stabilize bone, not reagents or instruments used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
This device is a surgical implant used for orthopedic fracture fixation.
N/A
Intended Use / Indications for Use
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.
Product codes
HSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humerus, Medullary canal of the humerus, Proximal humerus, Humeral shaft
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
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.
Key Metrics
Not Found
Predicate Device(s)
K033071, K103002, K090241, K000089, K000684
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small circle with a dot inside is located to the upper right of the letter "S" in "SYNTHES".
K120807+"1/
| 3.0 | 510(k) Summary | |
|---|---|---|
| ----- | -- | ---------------- |
| Sponsor: | Synthes (USA)
Rebecca G. Blank
Associate Regulatory Affairs Specialist
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-1268
FAX (484) 356-9682 | | JUL | 6 2012 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----|--------|
| Date Prepared: | March 15, 2012 | | | |
| Device Name: | Synthes MultiLoc Humeral Nailing System | | | |
| Classification: | Class II, §888.3020 – Intramedullary fixation rod
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.
1
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
2
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 (800) 638-2041 or (301) 796-7100 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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with a registered trademark symbol is located to the right of the word.
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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