(59 days)
Not Found
Not Found
No
The device description details a physical implant (a glenoid component for shoulder surgery) and its mechanical features. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is an implantable glenoid component designed to reproduce the function of the natural glenoid in the shoulder, which is a therapeutic intervention for a medical condition.
No
The device described is an implant (a glenoid component for shoulder replacement), which is a treatment device, not a diagnostic one. Its purpose is to reproduce the function of a natural glenoid, not to diagnose a condition.
No
The device description clearly describes a physical implant (Pegged All-Poly Glenoid) made of material (ASTM F648) and designed for surgical implantation, indicating it is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "Pegged All-Poly Glenoid" intended to "reproduce the function of the natural glenoid" and is "cemented into the subchondral bone of the glenoid cavity." This describes a surgical implant used in vivo (within the body) to replace a joint component.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to disease or health conditions.
Therefore, the device described is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The Pegged All-Poly (ASTM F648) Glenoid is a one piece design intended to reproduce the function of the natural glenoid. The design of this glenoid component allows use in the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
The Pegged All-Poly Glenoid Component features a flat back, two grooved pegs and a circumferential dovetail cement groove on the medial surface to provide translational and rotational stability to the implant as well as to enhance cement fixation. The peg grooves allows for intraoperative trimming in the event of shallow glenoid anatomy. The concave lateral surface of the glenoid implant accommodates the humeral head. The geometry of the component is nonconstrained. Titanium pins in the inferior and superior aspects of the component assist in postoperative evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, glenoid cavity
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
Contact area testing indicated that the Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
AUG - 9 1996
K962244
1996
June 7, 1996
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. Select® Shoulder All-Poly Glenoids.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9900 |
|----------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Regulatory Affairs Manager |
| Classification Name: | 21 CFR Part 888.3650 - Shoulder joint metal/polymer non-
constrained cemented prosthesis |
| Common/Usual Name: | Glenoid prosthesis |
| Trade/Proprietary: | Select® Shoulder Pegged All-Poly Glenoids |
Product Description/Substantial Equivalence:
The Pegged All-Poly (ASTM F648) Glenoid is a one piece design intended to reproduce the function of the natural glenoid. The design of this glenoid component allows use in the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
The Pegged All-Poly Glenoid Component features a flat back, two grooved pegs and a circumferential dovetail cement groove on the medial surface to provide translational and rotational stability to the implant as well as to enhance cement fixation. The peg grooves allows for intraoperative trimming in the event of shallow glenoid anatomy. The concave lateral surface of the glenoid implant accommodates the humeral head. The geometry of the component is nonconstrained. Titanium pins in the inferior and superior aspects of the component assist in postoperative evaluation.
Contact area testing indicated that the Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.
The designs are substantially equivalent to the glenoids used in the Orthomet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Coffield Shoulder, the Kirschner/Biomet Modular Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuy Global Total Shoulder System.