(145 days)
No
The device description focuses on mechanical components (rods, screws, nails) and their material properties and mechanical performance. There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is implanted to fix fractures of the proximal humerus, directly treating and alleviating a medical condition.
No
Explanation: The device is described as an intramedullary nailing system for fixing fractures, which is a therapeutic rather than diagnostic function. It is implanted to treat a condition, not to identify or monitor one.
No
The device description explicitly states it consists of "metallic rods and accessories which are intended for implantation" and describes physical components like "intramedullary nail devices," "bone screw and end cap accessories," and their materials (titanium alloy, polymer inlay). This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of fractures" in the proximal humerus. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details metallic rods and accessories intended for "implantation in the medullary canal of the proximal humerus." This is a description of an implantable surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body to treat a physical condition.
N/A
Intended Use / Indications for Use
The Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.
Product codes
HSB
Device Description
The Synthes MultiLoc Proximal Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the proximal humerus for the fixation of fractures. The system features intramedullary nail devices, as well as 4.5mm bone screw and end cap accessories. The nails are cannulated, are offered in 8.0mm and 9.0mm diameters, and 160mm in overall length. The nail, screw, and end cap devices are composed of titanium alloy. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc proximal locking screws. The 4.5mm MultiLoc Screws which are used to facilitate the proximal locking of the nail construct can be interlocked with existing 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
proximal humerus
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)
To additionally support substantial equivalence, calculations comparing the bending strength of the subject and predicate devices based on geometric analyses and material characteristics defined in standard ASTM F1295-05 were performed as well as in vitro mechanical testing. The in vitro bench testing included static and dynamic bend, torsional strength, and dynamic fatigue strength of the construct and was conducted in comparison with the predicate devices and the results support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033071, K082754, K090241, K000089, K041860, 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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a human figure inside of a circle. There is a horizontal line underneath the word "SYNTHES".
3.0 510(k) Summary | K103002 Page 1 of 2 |
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Sponsor: | Synthes (USA) |
Karl J. Nittinger | |
1301 Goshen Parkway | |
West Chester, PA 19380 | |
(610) 719-6941 | |
FAX (484) 356-9682 | |
MAR - 2 2011 | |
Date Prepared: | October 4, 2010 |
Device Name: | Synthes MultiLoc Proximal Humeral Nailing System |
Classification: | Class II, §888.3020 – Intramedullary fixation rod |
Product Code: HSB | |
Predicate Device: | Synthes Cannulated Titanium Humeral Nail System (K033071) |
Tornier Aequalis Humeral Nail System (K082754) | |
Synthes Angular Stable Locking System [ASLS] (K090241) | |
Synthes 4.0mm and 5.0mm Locking Screws (K000089) | |
Synthes 3.5mm LCP Proximal Humerus Plates (K041860) | |
Synthes 3.5mm Locking Screws (K000684) | |
Device Description: | The Synthes MultiLoc Proximal Humeral Nailing System consists |
of metallic rods and accessories which are intended for | |
implantation in the medullary canal of the proximal humerus for the | |
fixation of fractures. | |
The system features intramedullary nail devices, as well as 4.5mm | |
bone screw and end cap accessories. The nails are cannulated, are | |
offered in 8.0mm and 9.0mm diameters, and 160mm in overall | |
length. The nail, screw, and end cap devices are composed of | |
titanium alloy. The nails additionally feature a polymer inlay in the | |
proximal end to enhance the stability of the 4.5mm MultiLoc | |
proximal locking screws. The 4.5mm MultiLoc Screws which are | |
used to facilitate the proximal locking of the nail construct can be | |
interlocked with existing Synthes 3.5mm Locking Screws to | |
enhance the stability of the construct. | |
Indications for use: | The Synthes MultiLoc Proximal Humeral Nailing System is |
indicated for fractures of the proximal humerus, including 2-part | |
surgical neck fractures, 3-part fractures, and 4-part fractures. | |
Substantial | |
Equivalence: | Information presented supports substantial equivalence of the |
Synthes MultiLoc Proximal Humeral Nailing System 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 |
! | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in bold, black font. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word "SYNTHES".
Substantial Equivalence (continued):
To additionally support substantial equivalence, calculations comparing the bending strength of the subject and predicate devices based on geometric analyses and material characteristics defined in standard ASTM F1295-05 were performed as well as in vitro mechanical testing. The in vitro bench testing included static and dynamic bend, torsional strength, and dynamic fatigue strength of the construct and was conducted in comparison with the predicate devices and the results support substantial equivalence.
KIO3008 ***
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 2 2011
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K103002
Trade/Device Name: Synthes Multiloc Proximal Humeral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 07, 2011 Received: February 09, 2011
Dear Mr. Nittinger:
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
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Page 2 - Mr. Karl J. Nittinger
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/ReportaProblem/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.
A. B. n h
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/4/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 figure inside. A small circle with a dot inside is located to the right of the word, indicating a registered trademark. The text and logo are all in black and white.
2.0
Indications for Use
510(k) Number (if known):
Synthes MultiLoc Proximal Humeral Nailing System Device Name:
Indications for Use:
Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.Mellerson
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Orthopedic,
Division starstive Devices Division of Surgious, and Restorative Devices
510(k) Number