(191 days)
Not Found
No
The document describes a mechanical orthopedic implant and its testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a prosthesis intended to replace parts of the glenohumeral joint due to fracture or disease, which is a restorative rather than therapeutic function.
No
The device is a prosthesis indicated for surgical repair of the glenohumeral joint due to degenerative, rheumatoid, or traumatic disease or injury, including fractures. It replaces or supplements the damaged joint rather than diagnosing a condition.
No
The device description explicitly states the device is manufactured from Titanium with a hydroxyapatite coating, indicating it is a physical implant, not software.
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.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a shoulder prosthesis) used to replace or repair damaged parts of the glenohumeral joint. Its intended use is to treat significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the shoulder, including fractures.
- Lack of Diagnostic Activity: The device itself does not perform any diagnostic testing on biological samples. It is a physical component implanted into the body.
The information provided focuses on the device's mechanical properties (fatigue testing) and biocompatibility (bacterial endotoxin testing), which are relevant for a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.
Product codes
KWS, HSD
Device Description
The fracture adapters are manufactured from Titanium with a hydroxyapatite (HA) coating and are offered in 10 sizes. The Fracture Adapters mate with a trunnion and FDA cleared Arthrex Humeral Stems and Heads for anatomic hemi shoulder prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, 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
Dynamic fatigue testing was performed to evaluate the fatigue resilience of the proposed construct. The testing demonstrates that the fatigue strength of the proposed devices meets the same acceptance criteria as the predicate device for the desired indications.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics
Not Found
Predicate Device(s)
K020345, K071032, K130129/K142863
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2018
Arthrex Inc. David Rogers Regional Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K181555
Trade/Device Name: Arthrex Fracture Adapter Hemi Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: November 19, 2018 Received: November 20, 2018
Dear David Rogers:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2018.12.21 16:10:24 -05'00' For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181555
Device Name
Arthrex Fracture Adapter Hemi Shoulder Prosthesis
Indications for Use (Describe)
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
- | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary or 510(k) Statement
| Date Prepared | December 20, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Regional Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex Fracture Adapter Hemi Shoulder Prosthesis |
| Common Name | Shoulder Prosthesis |
| Product Code | KWS, HSD |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis | |
| 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented | |
| prosthesis | |
| Regulatory Class | II |
| Predicate Device | K020345: Arthrex Univers Fracture Prosthesis |
| K071032: Arthrex Univers II Shoulder Prosthesis | |
| K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System | |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| a product line of fracture adapters to be used with FDA cleared Arthrex humeral | |
| stems and heads for anatomic hemi shoulder prosthesis. | |
| Device Description | The fracture adapters are manufactured from Titanium with a hydroxyapatite |
| (HA) coating and are offered in 10 sizes. The Fracture Adapters mate with a | |
| trunnion and FDA cleared Arthrex Humeral Stems and Heads for anatomic hemi | |
| shoulder prosthesis. | |
| Indications for Use | The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for severe |
| pain or significant disability resulting from degenerative, rheumatoid, or | |
| traumatic disease or injury of the glenohumeral joint. This includes traumatic or | |
| pathological conditions of the shoulder resulting in fracture of the glenohumeral | |
| joint, including impression fractures, comminuted fracture, humeral head | |
| fracture, displaced 3-or-4-fragment proximal head fractures, avascular necrosis of | |
| the humeral head, and fractures of the anatomical neck. |
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The
device may be used for hemi or total shoulder repair, utilizing the appropriate
Arthrex Univers Glenoid component, which is to be cemented in place. |
| Performance Data | Dynamic fatigue testing was performed to evaluate the fatigue resilience of the
proposed construct. The testing demonstrates that the fatigue strength of the
proposed devices meets the same acceptance criteria as the predicate device for
the desired indications.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is substantially
equivalent to the predicate device in which the basic design features and |
| intended uses are the same. Any differences between the proposed device and
the predicate device are considered minor and do not raise questions concerning
safety or effectiveness. | |
| Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. | |
4