(41 days)
No
The summary describes a mechanical implant (total shoulder prosthesis) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device description and intended use indicate it is an orthopedic implant (total shoulder prosthesis) used to relieve pain and restore motion by replacing damaged joint components, which is a therapeutic function, but it is not classified as a "therapeutic device" in the context of devices that deliver or monitor therapy via electronic or software means.
No
The document describes a total shoulder prosthesis, an implant used in surgery, not a device that diagnoses medical conditions.
No
The device description clearly states it is a total shoulder prosthesis made of UHMWPE, which is a physical implant, 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 this is a total shoulder prosthesis for surgical implantation to treat various shoulder conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a physical implant (humeral stem, head, and glenoid component) used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace damaged joint components.
N/A
# Intended Use / Indications for Use
This total shoulder prosthesis is intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. This system includes a humeral stem and head and is to be used with bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
# Product codes
Not Found
# Device Description
The glenoid is fabricated from UHMWPE (ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and humeral head to allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has either a keel or three pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in five sizes for each component, the keeled and pegged components.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
shoulder
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
surgeon
# 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)
Not Found
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s)
[K960906](https://510k.innolitics.com/search/K960906), [K960906](https://510k.innolitics.com/search/K960906)
# Reference Device(s)
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 1 5 1996
Summary of Safety and Effectiveness
Encore Orthopedics®. Inc. 8900 Shoal Creek Bldg 300 Austin, TX 78757 512-206-1437 March 1, 1996 Ashley M. Bock
Common Name: Glenoid Component for the Foundation™Total Shoulder System
Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR 888.3660
Description: The glenoid is fabricated from UHMWPE (ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and humeral head to allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has either a keel or three pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in five sizes for each component, the keeled and pegged components.
Intended Use: This total shoulder prosthesis is intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. This system includes a humeral stem and head and is to be used with bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
Comparable Features to Predicate Device(s): Encore Foundation™ Total Shoulder System Kirshner Neer II™ Glenoid Component Intermedics Select™ Shoulder Glenoid Component