(196 days)
Not Found
No
The device description focuses on the materials and mechanical components of a shoulder replacement system and associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total and hemi-shoulder prosthesis intended to treat severe joint conditions and fractures, directly addressing a medical problem to heal or alleviate symptoms.
No
Explanation: The device is a shoulder prosthesis system intended for joint replacement, not for diagnosing medical conditions. Its function is to replace damaged shoulder components, not to identify or characterize diseases.
No
The device description clearly outlines multiple hardware components made from various materials (Ti-6A1-4V alloy, Co-Cr-Mo alloy, UHMWPE, tantalum) and includes instruments for cutting and manipulating bone graft. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Humelock II Cemented Shoulder System Function: The Humelock II Cemented Shoulder System is a surgical implant used to replace parts of the shoulder joint. It is a physical device implanted into the body to restore function and alleviate pain.
- Lack of Biological Sample Analysis: The description of the Humelock II system and its intended use does not involve the analysis of any biological samples from the patient. It is a mechanical device for surgical implantation.
Therefore, based on the provided information, the Humelock II Cemented Shoulder System clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
-
- Proximal humeral fractures
-
- A severely painful and and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWT, HSD
Device Description
The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, and, when used for total shoulder replacement, a glenoid component.
The humeral stem is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. 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-6Al-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm in centered and offset styles. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, and large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The current submission adds bone graft cutting and manipulating instruments and graft trials to the Humelock II Shoulder System.
Bone graft cutting and manipulating instruments and graft trials may be used to cut bone graft from the humeral head and position it around the humeral stem. The bone graft can be used to help position and consolidate the tuberosities in cases with proximal bone loss.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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)
Non-Clinical Testing: Characterization of the colorant used in the bone graft trial instruments is provided in a device master file and is referenced in this submission. Mechanical testing of the Humelock II Cemented Stem, the Humelock glenoid and the modular connections between components was provided previously.
Clinical Testing: Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123814 - Humelock II Cemented Shoulder System, K994392 - Tornier Aequalis Shoulder Fracture System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Page 1/2
JUL 2 8 2014 510(k) Summary Prepared On: June 23, 2014 Applicant / Manufacturer: Fx Solutions 1663 rue de Majornas 01440 Viriat France Contact: Jean-Jacques Martin +33 4 74 55 35 55 www.fxsolutions.fr Proprietary Name: Humelock II Cemented Shoulder System Common Name: Total and Hemi-Shoulder Replacement System 21 CFR 888.3650: Shoulder joint metal/polymer non Classification Names: constrained cemented prothesis, Class II 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, Class II Product Codes: KWT, HSD Substantially K123814 - Humelock II Cemented Shoulder System Equivalent Devices: K994392 - Tornier Aequalis Shoulder Fracture System
Device Description:
The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, and, when used for total shoulder replacement, a glenoid component.
The humeral stem is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. 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-6Al-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm in centered and offset styles. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
1
K140071
The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, and large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The current submission adds bone graft cutting and manipulating instruments and graft trials to the Humelock II Shoulder System.
Bone graft cutting and manipulating instruments and graft trials may be used to cut bone graft from the humeral head and position it around the humeral stem. The bone graft can be used to help position and consolidate the tuberosities in cases with proximal bone loss.
Intended Use / Indications:
The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
-
- Proximal humeral fractures
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic 2. arthritis or rheumatoid arthritis;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.
Summary of Technologies/Substantial Equivalence:
Substantial equivalence of the Humelock II Cemented Shoulder Prosthesis to the predicate devices is based on comparisons of indications, intended use, matcrials, and design.
Non-Clinical Testing:
Characterization of the colorant used in the bone graft trial instruments is provided in a device master file and is referenced in this submission. Mechanical testing of the Humelock II Cemented Stem, the Humelock glenoid and the modular connections between components was provided previously.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems.
2
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2014
Fx Solutions Mr. Jean-Jacques Martin 1663 rue de Majornas 01440 Viriat France
Re: K140071
Trade/Device Name: Humelock II Cemented Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, HSD Dated: June 26. 2014 Received: June 26, 2014
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 Mcdical 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
3
Page 2 - Mr. Jean-Jacques Martin
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K140071 510(k) Number (if known):
Device Name: Humelock II Cemented Shoulder System
Indications for Use:
The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
-
- Proximal humeral fractures
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.
Prescription Use_ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (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)
Page 1 of 1
7