(234 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is a hemi shoulder replacement system, which is a type of medical implant designed to treat fractures of the proximal humerus, thereby providing a therapeutic effect by restoring function and alleviating pain due to the fracture.
No
The device description indicates it is a hemi-shoulder prosthesis intended for surgical replacement, not for diagnosing medical conditions.
No
The device description clearly outlines multiple physical components made of various alloys (humeral stem, humeral head, screws, etc.), indicating it is a hardware-based medical device.
Based on the provided information, the Humelock II Cementless Shoulder System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for hemi shoulder replacement for fractures of the proximal humerus. This is a surgical implant used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details the components of a prosthetic joint (humeral stem, head, connector, screws). These are physical implants designed to function mechanically within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. The Humelock II Cementless Shoulder System is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.
Product codes
HSD
Device Description
The Humelock II Cementless Shoulder System is a hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, cortical bone screws and an optional protector and hex screw to prevent bone ingrowth into the threaded hole in the proximal stem.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The distal end of the humeral component is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the anterior / posterior direction for fixation using bone screws.
The proximal portion of the humeral component has a plasma sprayed commercially pure Titanium (CP Ti) coating and a hydroxyapatite (HA) coating. A hole in the proximal portion of the humeral component allows attachment to instrumentation designed to provide correct positioning (height and retroversion) of the implant. The humeral stem is available in sizes 8 - 15.
The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral·head.
The double taper connector is manufactured from Ti-6A1-4V allor conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end and is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the connector.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
The cortical bone screws are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and are available with a diameter of 4.5mm in lengths of 18 - 40mm in 2mm increments.
The screw hole protector and hex screw are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint 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
Mechanical testing was conducted to demonstrate the fatigue strength of the humeral stem and the stability of the modular connection between the double taper connector and the humeral stem. Pull off testing of the humeral head from the taper was conducted previously. Characterization data was provided for the CP Titanium plasma sprav coating and the hydroxvapatite coating. Clinical testing was not necessary to determine substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K992525, K111097, K060874, K103835
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
| 3. 510(k) Summary | ||
|---|---|---|
| Prepared On: | March 18, 2013 | |
| Applicant / Sponsor: | Fx Solutions | |
| 1663 rue de Majornas | ||
| 01440 Viriat | ||
| France | NOV 09 2013 | |
| Manufacturer: | Compagnie Financière & Médicale | |
| 13 Bd Victor Hugo | ||
| 01000 Bourg En Bresse | ||
| France | ||
| Contact: | Jean-Jacques Martin | |
| +33 4 74 55 35 55 | ||
| www.fxsolutions.fr | ||
| Proprietary Name: | Humelock II Cementless Shoulder System | |
| Common Name: | Hemi-Shoulder Replacement System | |
| Classification Names: | 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) | |
| metallic uncemented prosthesis, Class II | ||
| Product Codes: | HSD | |
| Substantially Equivalent Devices: | K992525 - Acumed Modular Shoulder System | |
| K111097 - Fx Solutions Humelock Cemented Shoulder | ||
| Prosthesis | ||
| K060874 - DePuy Global AP Shoulder System | ||
| K103835 - Howmedica Osteonics ReUnion TSA System |
Device Description:
The Humelock II Cementless Shoulder System is a hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, cortical bone screws and an
1
optional protector and hex screw to prevent bone ingrowth into the threaded hole in the proximal stem.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The distal end of the humeral component is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the anterior / posterior direction for fixation using bone screws.
The proximal portion of the humeral component has a plasma sprayed commercially pure Titanium (CP Ti) coating and a hydroxyapatite (HA) coating. A hole in the proximal portion of the humeral component allows attachment to instrumentation designed to provide correct positioning (height and retroversion) of the implant. The humeral stem is available in sizes 8 - 15.
The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral·head.
The double taper connector is manufactured from Ti-6A1-4V allor conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end and is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the connector.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
The cortical bone screws are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and are available with a diameter of 4.5mm in lengths of 18 - 40mm in 2mm increments.
The screw hole protector and hex screw are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
2
Intended Use / Indications:
The Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.
Summary of Technologies/Substantial Equivalence:
Substantial equivalence of the Humelock II Cementless Shoulder Prosthesis to the predicate devices is based on a comparison of indications, intended use, materials, design and sizing, and mechanical testing.
Non-Clinical Testing:
Mechanical testing was conducted to demonstrate the fatigue strength of the humeral stem and the stability of the modular connection between the double taper connector and the humeral stem. Pull off testing of the humeral head from the taper was conducted previously. Characterization data was provided for the CP Titanium plasma sprav coating and the hydroxvapatite coating.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cementless Shoulder System and the predicate shoulder systems.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2013
Fx Solutions Mr. Jean-Jacques Martin 1663 Rue De Maiornas 01440 Viriat France
Re: K130759
Trade/Device Name: Humelock II Cementless Shoulder System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: October 3, 2013 Received: October 8, 2013
Dear Mr. Martin:
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 docs 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 four d 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
4
Page 2 - Mr. Jean-Jacques Martin
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, picase 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.hum.
Sincerely yours.
Image /page/4/Picture/7 description: The image shows the name "Erin I. Keith" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The image is simple and straightforward, with no other elements present.
for
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K130759
Device Name: Humelock II Cementless Shoulder System
Indications for Use:
The Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.
Over-The-Counter Use _ . Prescription Use -X-AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE),
Page + of 4
Casey L. Hanley, Ph.D
Division of Orthopedic Devices