(309 days)
No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an orthopedic implant for partial or total shoulder arthroplasty, which is a therapeutic procedure to treat conditions like significant disability in glenohumeral joint diseases or avascular necrosis of the humeral head.
No
The device is an orthopedic implant for shoulder arthroplasty, which is a therapeutic intervention, not a diagnostic one. Its purpose is to treat existing conditions, not to identify or diagnose them.
No
The device description clearly states the device is a physical orthopedic implant made of Titanium Alloy and CoCr, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "orthopedic implant for partial or total shoulder arthroplasty." This is a surgical procedure performed in vivo (within the body) to replace or repair a joint.
- Device Description: The description details the materials and components of a physical implant designed to be surgically placed in the shoulder.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
-
significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
-
avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
Product codes (comma separated list FDA assigned to the subject device)
MBF, KWT, KWS, HSD
Device Description
The Shoulder Innovations Humeral Short Stem consists of modular humeral stems and heads and articulates with the Shoulder Innovations glenoid component (K111596). The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head
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)
Performance testing was performed on the Shoulder Innovations Humeral Stem System. The modular humeral components were tested per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses. Fatigue testing was also performed on the humeral components.
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
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement 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 (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
Shoulder Innovations Inc Don Running VP R&D 13827 Port Sheldon Street Holland, Michigan 49424
October 23, 2018
Re: K173824
Trade/Device Name: Humeral Short Stem System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, HSD Dated: September 12, 2018 Received: September 14, 2018
Dear Don Running:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 2018.10.23 16:48:03 -04'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173824
Device Name Humeral Short Stem System
Indications for Use (Describe)
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
-
significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
-
avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
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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510(k) Summary Pursuant to 21 CFR 807.92c
| Date Prepared: | September 12, 2018 |
|---|---|
| Submitted By: | Shoulder Innovations, LLC |
| 13827 Port Sheldon St. | |
| Holland, MI 49424 | |
| Contact: | Don Running |
| VP-R&D | |
| 574-253-1133 | |
| don@genesisinnovationgroup.com | |
| Proprietary Name: | Humeral Short Stem System |
| Common Name: | Shoulder Prosthesis |
| Classification: | 21 CFR Section 888.3670 – Shoulder joint metal/ |
| polymer/metal nonconstrained or semi-constrained | |
| porous-coated uncemented prosthesis | |
| Product Code: MBF | |
| 21 CFR Section 888.3650 – Shoulder joint | |
| metal/polymer non-constrained cemented | |
| prosthesis. | |
| Product Code: KWT | |
| 21 CFR Section 888.3660 – Shoulder joint | |
| metal/polymer semi-constrained cemented | |
| prosthesis. | |
| Product Code: KWS | |
| 21 CFR Section 888.3690 – Shoulder joint humeral | |
| (hemi-shoulder) metallic uncemented prosthesis. | |
| Product Code: HSD | |
| Substantially | |
| Equivalent Device: | K060692, Biomet Comprehensive® Primary Shoulder |
| Stems |
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Device Description:
The Shoulder Innovations Humeral Short Stem consists of modular humeral stems and heads and articulates with the Shoulder Innovations glenoid component (K111596). The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.
Intended Use / Indications:
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
-
- significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
-
- avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
Predicate Device Comparison:
Humeral Stem Component
| Feature | Biomet
Comprehensive
Primary Shoulder
Stems (K060692) | Proposed Device
Shoulder
Innovations
Humeral Short
Stem System | SE? |
|--------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------|-----|
| Distal Stem
Diameters | 5.75 mm
(Labeled 4mm) | 5.75 mm | Yes |
| Stem
Lengths | 72 mm | 70 mm | Yes |
| Stem Geometry | Tapered circular | Tapered circular | Yes |
| Collar | Collarless | Collarless | Yes |
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| Feature | Biomet
Comprehensive
Primary Shoulder
Stems (K060692) | Proposed Device
Shoulder
Innovations
Humeral Short
Stem System | SE? |
|------------------|----------------------------------------------------------------|----------------------------------------------------------------------------|-----|
| Modular system | Female Morse-type
taper | Female Morse-type
taper | Yes |
| Bone Integration | Porous Coating | Porous Coating | Yes |
| Neck Angle | 135° | 132.5° | Yes |
| Fixation | Press-fit or
Cemented | Press-fit or
Cemented | Yes |
| Material | Titanium Alloy | Titanium Alloy | Yes |
| Sterility | Gamma Irradiated | Gamma Irradiated | Yes |
Humeral Head Component
| Feature | Biomet
Comprehensive
Primary Shoulder
Stems (K060692) | Proposed Device
Shoulder
Innovations
Humeral
Short Stem
System | SE? |
|-------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------|-----|
| Head
Diameters | 38, 42, 46, 50, 54, 58mm | 40mm, 44mm, 48mm, 52mm, and 56mm | Yes |
| Head Heights | 18mm - 27mm | 15mm - 24mm | Yes |
| Configurations | Standard and Offset | Standard and Offset | Yes |
| Geometry | Solid semi-sphere | Solid semi-sphere | Yes |
| Modular system | Male Morse-type
taper | Male Morse-type
taper | Yes |
| Material | CoCr | CoCr | Yes |
| Sterility | Gamma Irradiated | Gamma Irradiated | Yes |
Non-Clinical Testing:
Performance testing was performed on the Shoulder Innovations Humeral Stem System. The modular humeral components were tested per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses. Fatigue testing was also performed on the humeral components.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Shoulder Innovations Humeral Short Stem System to the predicate device.
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Summary of Substantial Equivalence:
The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Humeral Short Stem System is substantially equivalent to the predicate device.