(91 days)
No
The document describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is an orthopedic implant (Total Shoulder System) used for partial or total shoulder arthroplasty to treat significant disability in degenerative, rheumatic disease of the glenohumeral joint and avascular necrosis of the humeral head. Its function is to replace damaged joint components, thereby restoring function and alleviating symptoms, which aligns with the definition of a therapeutic device.
No
This device is an orthopedic implant (a total shoulder system) used for partial or total shoulder arthroplasty, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of Titanium Alloy, CoCr, and UHMWPE, which are hardware implants for shoulder arthroplasty.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Shoulder Innovations Total Shoulder System is an orthopedic implant intended for surgical implantation to treat conditions of the shoulder joint. It is a physical device that replaces or augments parts of the shoulder.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information. Its function is purely therapeutic and structural.
Therefore, the Shoulder Innovations Total Shoulder System falls under the category of a surgical implant, not an In Vitro Diagnostic device.
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, rheumatic 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)
KWT, KWS, MBF, HSD
Device Description
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. 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.
The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Glenohumeral joint, humeral head, 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:
The Augmented Glenoids were evaluated to demonstrate substantial equivalence to the predicate devices. Testing was performed in accordance with ASTM F2028-17, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. Cadaver testing of the Augmented Glenoids was also performed. The test results demonstrated that the Augmented Glenoids are adequate for their intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Shoulder Innovations Total Shoulder System Augmented Glenoids 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
§ 888.3650 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.”
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Image /page/0/Picture/0 description: The image shows 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.
November 29, 2019
Shoulder Innovations Inc Don Running VP R&D 13827 Port Sheldon Street HOLLAND, MI 49424
Re: K192365
Trade/Device Name: Shoulder Innovations Total 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, KWS, MBF, HSD Dated: October 25, 2019 Received: November 1, 2019
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192365
Device Name
Shoulder Innovations Total Shoulder 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, rheumatic disease of the glenohumeral joint; 2. 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | August 27, 2019 |
|---|---|
| Submitter: | Shoulder Innovations |
| 13827 Port Sheldon St. | |
| Holland, MI 49424 | |
| Contact: | Don Running |
| Vice President – R&D | |
| Shoulder Innovations | |
| (574) 253-1133 | |
| don@genesisinnovationgroup.com | |
| Proprietary Name: | Shoulder Innovations Total Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification: | 21 CFR Section 888.3650 – Shoulder joint metal/polymer non- |
| constrained cemented prosthesis; Class II | |
| Product Code: KWT |
21 CFR Section 888.3660 – Shoulder joint metal/polymer
semi-constrained cemented prosthesis; Class II
Product Code: KWS
21 CFR Section 888.3670 – Shoulder joint
metal/polymer/metal nonconstrained or semi-constrained
porous-coated uncemented prosthesis; Class II
Product Code: MBF
21 CFR Section 888.3690 – Shoulder joint humeral (hemi-
shoulder) metallic uncemented prosthesis; Class II
Product Code: HSD |
| Substantially
Equivalent Devices: | K111596 – Shoulder Innovations Total Shoulder System
(glenoid modification)
K173824 - Shoulder Innovations Humeral Short Stem System
(humeral modification) |
| Reference Device: | K121220 – Exactech Equinoxe UHMWPE 16° Posterior
Augmented Pegged Glenoids |
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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.
The indications for use are unchanged from K173824 for the Total Shoulder System.
Device Description:
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. 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.
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The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.
Proposed Modification:
The subject of this submission is a line extension to add the Augmented Glenoids to the Shoulder Innovations Total Shoulder System. The Augmented Glenoids are almost identical to the previously cleared glenoid component (K111596) except for an angled articular surface, creating the augmented glenoid. The Augmented Glenoids are available in both 5° and 10° variants. The Augmented Glenoids are manufactured from UHMWPE conforming to ASTM F648, which is the same material as the previously cleared glenoid components, utilizing the same manufacturing processes. The Augmented Glenoids are available in multiple widths.
All Shoulder Innovations Total Shoulder System Augmented Glenoids are compatible with the previously cleared Total Shoulder System humeral components (K102670 and K173824).
Non-Clinical Testing:
The Augmented Glenoids were evaluated to demonstrate substantial equivalence to the predicate devices. Testing was performed in accordance with ASTM F2028-17, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. Cadaver testing of the Augmented Glenoids was also performed. The test results demonstrated that the Augmented Glenoids are adequate for their intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Shoulder Innovations Total Shoulder System Augmented Glenoids to the predicate devices.
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Predicate Device Comparison:
| Property or Characteristic | Shoulder Innovations
Total Shoulder System
Glenoid Component
(K111596) | Shoulder Innovations Total
Shoulder System Augmented
Glenoids
(Current Submission) |
|-------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Material | UHMWPE | Same as K111596 |
| Articulating Surface Geometry | Concave with modified radius
of curvature | Same as K111596 |
| Minimum Poly Thickness | 3.3 mm | Same as K111596 |
| Perimeter Geometry | Ellipse with sides trimmed at
an acute angle | Ellipse with sides trimmed
parallel |
| Angle of articular surface | None | 5° or 10° |
| Provided Sterile | Yes | Same as K111596 |
| Fixation Method | Cemented Only | Same as K111596 |
Summary of Technologies / Substantial Equivalence:
The Shoulder Innovations Augmented Glenoids are substantially equivalent to the Shoulder Innovations Total Shoulder System glenoid components in regard to indications for use, material and design. The angling of the articular surface of the glenoid to create the Augmented Glenoids does not raise new questions in regard to safety and effectiveness of the device, nor are there new technological issues.