(232 days)
Not Found
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
The device is an orthopedic implant for shoulder arthroplasty, which is a surgical procedure to replace or restore a damaged joint, thus providing a therapeutic effect for conditions like degenerative diseases, fractures, or avascular necrosis.
No
Explanation: The device is an orthopedic implant for shoulder arthroplasty, which is a surgical treatment. It does not perform any diagnostic functions like analyzing an image or biological sample to provide information about a patient's medical condition.
No
The device description clearly details 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:
- 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 involving the replacement of a joint.
- Device Description: The description details the materials and components of a physical implant (stems, heads, glenoid component) designed to be surgically inserted into the body.
- 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 screening.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, 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;
-
- Fractures of the humeral head
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- Avascular necrosis of the humeral head
-
- Revision where other devices or treatments have failed.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The InSet 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, 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 peqged 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
Shoulder joint, glenohumeral joint, humeral head, proximal humerus
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 included stem mechanical strength evaluation via cyclic fatique testing.
Clinical testing was not necessary to demonstrate substantial equivalence of the InSet Total Shoulder System InSet 95 Humeral Stem to the predicate device.
Key results: The InSet 95 Humeral Stem was evaluated to demonstrate substantial equivalence to the predicate devices. Non-clinical evaluation demonstrated that subject device is substantially equivalent to the legally marketed predicate device.
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.
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
February 11, 2025
Image /page/0/Picture/1 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 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.
Shoulder Innovations, Inc. Mark Hanes Sr. Technical Director 1535 Steele Ave SW. Suite B Grand Rapids, Michigan 49507
Re: K241817
Trade/Device Name: InSet 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, HSD Dated: January 9, 2025 Received: January 10, 2025
Dear Mark Hanes:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Digitally signed by Farzana Sharmin -S Date: 2025.02.11 14:36:19 -05'00'
Farzana Sharmin, PhD 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
3
Indications for Use
Submission Number (if known)
Device Name
Inset Total Shoulder System
Indications for Use (Describe)
The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, 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;
-
- Fractures of the humeral head
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- Avascular necrosis of the humeral head
-
- Revision where other devices or treatments have failed.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The InSet 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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4
Image /page/4/Picture/0 description: The image shows the logo for Shoulder Innovations. The logo consists of a blue circle with a green circle overlapping it slightly. Below the circles, the word "SHOULDER" is written in a sans-serif font, and below that, the word "INNOVATIONS" is written in a smaller font.
510(k) Summary
| Date Prepared: | February 7, 2025 |
|---|---|
| Submitter: | Shoulder Innovations, Inc. |
| 1535 Steele Ave SW, Suite B | |
| Grand Rapids, MI 49507 | |
| Contact: | Mark D. Hanes, Ph.D |
| Sr. Technical Director | |
| Shoulder Innovations, Inc. | |
| (574) 575-0903 | |
| Mark.Hanes@GenesisInnovationGroup.com | |
| Proprietary Name: | InSet Total Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | Shoulder Joint Metal/Polymer Non-Constrained Cemented |
| Prosthesis | |
| Regulation Number: | 21 CFR 888.3650 |
| Classification Code: | KWT |
| KWS | |
| HSD | |
| Review Panel: | Orthopedic |
| Substantially | |
| Equivalent Devices: | Primary Predicate K192365 - Shoulder Innovations, Total |
| Shoulder System | |
| Additional Predicate K212737 – INHANCE™ Reverse | |
| Shoulder System | |
| Additional Predicate K060692 - Comprehensive® Primary | |
| Shoulder Stems |
5
Image /page/5/Picture/0 description: The image shows the logo for Shoulder Innovations. The logo consists of two overlapping circles, one teal and one green, positioned above the company name. The company name, "SHOULDER," is written in a simple, sans-serif font, with the word "INNOVATIONS" appearing in a smaller font size below it.
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 peqged design intended for cemented fixation only.
Indications for Use:
The Shoulder Innovation's InSet Total Shoulder System, when used with the InSet Stem, 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 qlenohumeral joint:
-
- Fractures of the humeral head
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- Avascular necrosis of the humeral head
-
- Revision where other devices or treatments have failed.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the qlenoid component for total shoulder arthroplasty.
The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be
6
Image /page/6/Picture/0 description: The image contains the logo for Shoulder Innovations. The logo consists of two overlapping circles, one blue and one green, above the words "SHOULDER" and "INNOVATIONS" stacked on top of each other. The word "SHOULDER" is in a larger, bolder font than the word "INNOVATIONS."
implanted by press-fit or cement fixation.
Proposed Modification:
The subject of this submission is a product line extension to add the InSet 95 Humeral Stem to the Shoulder Innovations InSet Total Shoulder System (K192365 and K173824). The InSet 95 Humeral Stem carries the same indications for use as the InSet Total Shoulder System with an additional indication for the treatment of humeral fractures. The fracture treatment indication is limited solely to the InSet Total Shoulder System when used with the InSet 95 Humeral Stem.
As with the predicate InSet Total Shoulder System humeral stems, the proposed InSet 95 Humeral Stem is collarless, the humeral head acts as the collar to prevent stem subsidence. The InSet 95 Humeral Stem is manufactured from Titanium Alloy conforming to ASTM F136, with fins to provide rotational stability that are coated with a rough, porous coating of commercially pure titanium according to ASTM F1580. The InSet 95 Humeral Stem has a female Morse-type taper to interface with the cleared InSet Total Shoulder System modular humeral heads. The InSet 95 Humeral Stem is indicated for either press-fit or cemented fixation.
Comparison of Technological Characteristics:
Shoulder Innovations InSet Total Shoulder System with Inset 95 Humeral Stem is substantially equivalent to the primary predicate device in that both the proposed and primary predicate device have the same intended use and have similar technological characteristics. Both the proposed and primary predicate are prosthesis systems intended to be implanted to partially or totally replace a shoulder joint. The technological features characteristics most similar between the proposed device and primary predicate device include identical taper connection design; stem body and contour design; initial fixation, ; proximal porous coating material designed to achieve biological fixation; base materials; sterilization; and device compatibility with full implant offerings in the InSet Total Shoulder System. The differences in technological characteristics do not raise new questions of safety and effectiveness.
Shoulder Innovations InSet Total Shoulder System has similar technological characteristics to the INHANCE™ Reverse Shoulder System, K212737. The proposed subject device and the proposed secondary predicate device has same Indications for Use Statement as follows:
- Revision where other devices or treatments have failed. O
- Fractures of the humeral head o
- Fractures of the proximal humerus, where other methods of treatment are о deemed inadequate
7
Image /page/7/Picture/0 description: The image shows the logo for Shoulder Innovations. The logo features a blue circle with a green circle overlapping it slightly. Below the circles, the word "SHOULDER" is written in a sans-serif font. Below the word "SHOULDER", the word "INNOVATIONS" is written in a smaller, sans-serif font.
The proposed subject device has the similar technological characteristics as the secondary predicate device, specifically, taper connection design, humeral head design material, fixation method and stem geometry. The difference in technological characteristics do not raise different questions of safety and effectiveness.
Non-Clinical Testing Summary:
The InSet 95 Humeral Stem was evaluated to demonstrate substantial equivalence to the predicate devices. Non-clinical testing included stem mechanical strength evaluation via cyclic fatique testing.
Clinical Testing Summary:
Clinical testing was not necessary to demonstrate substantial equivalence of the InSet Total Shoulder System InSet 95 Humeral Stem to the predicate device.
Overall Conclusion:
The InSet Total Shoulder System with InSet 95 Humeral Stem is substantially equivalent to the InSet Total Shoulder System humeral stem components regarding intended use, material, and design. The geometric modifications to create the InSet 95 Humeral Stem indicated for humeral fracture treatment does not raise different questions regarding safety and effectiveness of the device. Non-clinical evaluation demonstrated that subject device is substantially equivalent to the legally marketed predicate device.