(110 days)
No
The summary describes a mechanical implant for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is an implant designed to reconstruct damaged shoulder joints, which directly aims to restore function and alleviate pain, classifying it as a therapeutic device.
No
This device is an implantable prosthesis used for surgical repair and replacement of shoulder joints, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a physical implant made of CoCrMo and UHMWPE, intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for reconstructing shoulder joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a physical implant designed to replace parts of the shoulder joint.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies focus on mechanical testing and bacterial endotoxin testing, which are relevant for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable.
The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty.
Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
HSD, KWS
Device Description
The OVOMotion™ Humeral prosthesis incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
The Arthrosurface OVOMotion™ Shoulder Arthroplasty System is intended as hemiarthroplasty or in conjunction with Sponsor's previously cleared and commercially marketed glenoid prosthesis (K091196) to repair and replace a shoulder joint when both articular surfaces of the joint are affected.
Humeral articular components are manufactured from CoCrMo and mate with corresponding Ti fixation component. Glenoid components are made from Ultra High Molecular Weight Polyethylene (UHMWPE). Both humeral and glenoid components are available in multiple sizes and curvatures and are intended to be implanted using bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joints
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)
The following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis
- Humeral Head mechanical testing – Assembly & Disassembly, Resistance to Torque, Cyclic Fatigue, Fretting Corrosion, Static Compression to Failure, Shear Testing and Lever Out.
- A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
The results have demonstrated that the OVOMotion™ Shoulder Arthroplasty System is substantially equivalent to the predicate devices.
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.
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.
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
§ 888.3690 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 18, 2018
Arthrosurface, Inc. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K173964
Trade/Device Name: OVOMotion™ Shoulder Arthroplasty System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Regulatory Class: Class II Product Code: HSD, KWS Dated: January 17, 2018 Received: January 18, 2018
Dear Dawn Wilson:
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 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);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
OVOMotion Shoulder Arthroplasty System
Indications for Use (Describe)
Indications for Use:
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable.
The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty.
Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.
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)
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| Section 5 | 510(k) Summary |
|---|---|
| ----------- | ---------------- |
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson
VP, Quality & Regulatory |
| Date of Preparation: | December 27, 2017 |
| Trade Name: | OVOMotion™ Shoulder Arthroplasty System |
| Common Name: | Shoulder Arthroplasty System |
| Classification Regulations: | 888.3690: Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis
888.3660: Shoulder joint metal/polymer semi-constrained
cemented prosthesis. |
| Product Codes: | HSD, KWS |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
Device Indications for Use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from posttraumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable.
The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty.
Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.
4
Device Description
The OVOMotion™ Humeral prosthesis incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
The Arthrosurface OVOMotion™ Shoulder Arthroplasty System is intended as hemiarthroplasty or in conjunction with Sponsor's previously cleared and commercially marketed glenoid prosthesis (K091196) to repair and replace a shoulder joint when both articular surfaces of the joint are affected.
Humeral articular components are manufactured from CoCrMo and mate with corresponding Ti fixation component. Glenoid components are made from Ultra High Molecular Weight Polyethylene (UHMWPE). Both humeral and glenoid components are available in multiple sizes and curvatures and are intended to be implanted using bone cement.
Substantial Equivalency:
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the OVOMotion Shoulder Arthroplasty System is substantially equivalent in indications and design principles to the following predicate(s) and/or reference devices, which have been previously cleared by the FDA:
| Primary Predicate:
| • Arthrosurface HemiCAP OVO Humeral System | K142942 |
|---|---|
| Additional Predicate: | |
| • Catalyst CSR Shoulder System | K152825 |
| Reference Device: | |
| • Arthrosurface GRS™ Glenoid Resurfacing System | K091196 |
| • Arthrosurface HemiCAP® Shoulder | K023096 |
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
- Has similar Indications for Use, .
- Uses the same operating principle,
- . Is manufactured using common orthopedic implant materials
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- Utilizes similar instrumentation for proper placement, .
- Is packaged and sterilized using the same materials and processes. .
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis
- . Humeral Head mechanical testing – Assembly & Disassembly, Resistance to Torque, Cyclic Fatigue, Fretting Corrosion, Static Compression to Failure, Shear Testing and Lever Out.
- . A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
The results have demonstrated that the OVOMotion™ Shoulder Arthroplasty System is substantially equivalent to the predicate devices.