(27 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the orthopedic implant, with no mention of AI or ML capabilities.
Yes
The device is an orthopedic implant designed to treat various conditions of the glenohumeral joint, aiming to restore function and alleviate disability.
No
Explanation: The document describes an orthopedic implant (Total Shoulder System) used for surgical repair or replacement of the shoulder joint. Its intended use is to treat various shoulder conditions, not to diagnose them. Diagnostic devices typically gather information about a patient's condition to aid in diagnosis, whereas this device is a therapeutic device.
No
The device description clearly states it consists of physical components (humeral stems, heads, and glenoid components) made of materials like Cobalt Chrome and UHMWPE, which are implanted into the body. This is a hardware medical device, not software-only.
No, 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 provided text clearly describes an orthopedic implant system designed to be surgically implanted into the shoulder joint to treat various conditions affecting the bones and tissues of the shoulder. It is a physical device used within the body, not a test performed on samples from the body.
The description focuses on the materials, design, and surgical application of the implant, which are characteristic of a non-IVD medical 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, rheumatoid, or traumatic . disease of the glenohumeral joint;
- united humeral head fractures of long duration: .
- . irreducible 3- and 4-part proximal humeral fractures:
- 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 components are intended for cemented fixation only; the humeral stem mav 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, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-pegged and keeled design and are 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
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 glenoid component was evaluated to demonstrate equivalence to the predicate devices. Performance testing was performed to evaluate glenoid loosening. An engineering study was performed to evaluate the minimum poly thickness and range of motion. No clinical testing was performed.
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
§ 888.3660 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
JUL - 5 2011
KII1596 510(k) Summary Pursuant to 21 CFR 807.92c
| Submitted By: | Andrew Rodenhouse |
|---|---|
| Shoulder Innovations, LLC | |
| 4670 Fulton St E, Suite 202 | |
| Ada, MI 49301 | |
| Ph: 616-706-3903 | |
| Fax: 616-877-4522 |
June 6, 2011 Date:
Device Information:
| Trade Name: | Total Shoulder System |
|---|---|
| ------------- | ----------------------- |
Common Name: Shoulder Prosthesis
Classification:
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:
K102670: Shoulder Innovation Total Shoulder System
K982981: Zimmer Bigliani/Flatow Total Shoulder System
Image /page/0/Picture/12 description: The image contains a logo and some text. The logo is a circle with a stylized figure inside. To the right of the logo is the text "Shoulder Innovation". The text is stacked vertically, with "Shoulder" on top of "Innovation".
Image /page/0/Picture/13 description: The image shows the title of a document, which is "Total Shoulder System Special 510(k): Device Modification". The document is labeled as "Page 1 of 3". The text is black and the background is white.
Page 5.2 CONFIDENTIAL
1
111596
Device Description:
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-pegged and keeled design and are intended for cemented fixation only.
Intended 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;
- united humeral head fractures of long duration: .
- . irreducible 3- and 4-part proximal humeral fractures:
- 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 components are intended for cemented fixation only; the humeral stem mav be implanted by press-fit or cement fixation.
S
Inn
Total Shoulder Svetom Special 510(k): Device Modifica CONFIDENTIAL
Page 2 of 3
2
KIU596
Proposed Modification:
This subject of this submission is a modification to the geometry of the articular surface of the glenoid component in the Shoulder Innovations Total Shoulder System.
Performance Data:
The glenoid component was evaluated to demonstrate equivalence to the predicate devices. Performance testing was performed to evaluate glenoid loosening. An engineering study was performed to evaluate the minimum poly thickness and range of motion. No clinical testing was performed.
Substantial Equivalence:
The results of non-clinical performance testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Total Shoulder System is substantially equivalent to the predicate device.
Image /page/2/Picture/7 description: The image contains a logo and the word "Shoulder Innovation". The logo is a circle with a stylized figure inside. The figure appears to be a person with their arm raised. The text "Shoulder Innovation" is to the right of the logo. The text is in a simple, sans-serif font.
Total Shoulder System
Special 510(k): Device Modification
CONFIDENTIAL
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 5 2011
Shoulder Innovations, LLC % Mr. Andrew Rodenhouse Principal Engineer 4670 Fulton Street E. Suite 202 Ada, Michigan 49301
Re: K111596
Trade/Device Name: Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD Dated: June 8, 2011 Received: June 8, 2011
Dear Mr. Rodenhouse:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Andrew Rodenhouse
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
fir Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number: | K111596 |
|---|---|
| ---------------- | --------- |
Total Shoulder System Device Name:
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;
-
- united humeral head fractures of long duration;
-
- irreducible 3- and 4-part proximal humeral fractures;
-
- 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.
Prescription Use メ (per CFR 801.109)
Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
bo m.Melleuson
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
or
510(k) Number K111596
Page 1 of 1
Shoulder
Innovat
otal Shoulder System Special 510(k): Device Modification
Page 4.2 CONFIDENTIAL