(223 days)
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Not Found
No
The description focuses solely on the mechanical components and materials of a total elbow replacement system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat medical conditions (osteoarthritis, rheumatoid arthritis) by replacing a joint, which falls under the definition of a therapeutic device.
No
The device is an elbow implant used for surgical replacement, not for identifying or investigating a disease.
No
The device description clearly outlines physical components made of Cobalt Chrome and UHMWPE, indicating it is a hardware medical device.
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: The provided text describes a surgical implant for replacing the elbow joint. It is made of materials like Cobalt Chrome and UHMWPE and is intended to be surgically implanted into the body.
- Intended Use: The intended use is to treat conditions like osteoarthritis and rheumatoid arthritis by replacing the damaged elbow joint. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device used within the body for treatment, not a device used to analyze samples from the body for diagnosis.
N/A
Intended Use / Indications for Use
The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required.
Indications: Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.
Product codes
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Device Description
Humeral Component: The humeral component of the Townley Total Elbow is manufactured of Cobalt Chrome (ASTM F-799). It is offered in both right and left designs and features a stabilizing intramedullary stem that is angled in five degrees of valgus to accommodate the normal carrying angle of the elbow. The proximal, bone-interfacing, non-articulating side of the body is designed with a squared receptical to accept the similarly remodeled humeral condyles. The articulating surface of the humeral component is contoured to allow a snap-fit with the ulnar component and is extended laterally to articulate with the radial head. It is offered in three sizes: 35mm, 40mm, and 45mm.
Ulnar Insert: The ulnar insert is manufactured of UHMWPE. The insert is designed to snap onto the humeral component and provide a stable joint while retaining multiplanar flexibility. It is offered in two sizes: small and large.
Ulnar Tray: The ulnar tray is manufactured of Cobalt Chrome (ASTM F-799). It features a L-shaped body which provides support for the polyethylene insert as well as a stem that aids in fixation. It is offered in two sizes: small and large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Capitello- Condylar Total Elbow manufactured by Johnson & Johnson
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
AUG - 8 1996
K955916 510 (k) Summary CLASS III
Submitted Bv: Biopro
17 17th Street Port Huron, MI 48060
Cheryl Warsinske Contact: (810) 982-7777 Fax (810) 982-7794
Device Information:
proprietary name: Townley Total Elbow System common name: Prosthetic, Total Elbow classification name: Prosthetic, Total Elbow
Predicate Device: Capitello- Condylar Total Elbow manufactured by Johnson & Johnson
Device Description:
Humeral Component: The humeral component of the Townley Total Elbow is manufactured of Cobalt Chrome (ASTM F-799). It is offered in both right and left designs and features a stabilizing intramedullary stem that is angled in five degrees of valgus to accommodate the normal carrying angle of the elbow. The proximal, bone-interfacing, non-articulating side of the body is designed with a squared receptical to accept the similarly remodeled humeral condyles. The articulating surface of the humeral component is contoured to allow a snap-fit with the ulnar component and is extended laterally to articulate with the radial head. It is offered in three sizes: 35mm, 40mm, and 45mm.
Ulnar Insert: The ulnar insert is manufactured of UHMWPE. The insert is designed to snap onto the humeral component and provide a stable joint while retaining multiplanar flexibility. It is offered in two sizes: small and large.
Ulnar Tray: The ulnar tray is manufactured of Cobalt Chrome (ASTM F-799). It features a L-shaped body which provides support for the polyethylene insert as well as a stem that aids in fixation. It is offered in two sizes: small and large.
Intended Use:
The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required.
Indications: Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.
Contraindications: Excessive bone loss, Septic arthritis, Periarticular osteomyelitis, and General health problems.
April 9, 1996
1
510 (k) Summary
Comparison of the Townley Elbow System vs. the Capitello-Condylar System
Image /page/1/Picture/2 description: In the image, a small electronic component is shown against a dark background. The component has a rectangular body with rounded edges, and two wires extend from either side. The wires are thin and metallic, and they appear to be made of copper. The component is likely a resistor or a capacitor, and it is used in electronic circuits to control the flow of electricity.
Image /page/1/Picture/3 description: The image shows a satellite in space. The satellite has a rectangular body with several square panels on its surface. There are two long, thin antennas extending from opposite sides of the satellite. The text in the image includes the words "Caball chromтьт", "Rumara: compens", "Posturse central grem", "for gehemped fixation", "UMPWPE U", and "by tray re".
Photograph of the Townley Elbow
Photograph of the Capitello-Condylar Elbow
| Humeral Component | Cobalt Chrome | Sizes Available |
|---|---|---|
| Capitello-Condylar | Yes | 2 |
| Townley System | Yes | 3 |
| Ulnar Tray | Cobalt | Universal Tray
(can be used on
right or left) | Sizes Available |
|--------------------|--------|-----------------------------------------------------|-----------------|
| Capitello-Condylar | Yes | No | 4 |
| Townley System | Yes | Yes | 2 |
| Ulnar Tray
Insert | Snapfits onto
Humeral
Components | UHMWPE | Universal Insert
(can be used on
right or left) |
|----------------------|----------------------------------------|--------|-------------------------------------------------------|
| Capitello-Condyl. | No | Yes | No |
| Townley System | Yes | Yes | Yes |
| Total Elbow Joint | Normal
Flexion/Extension | Resists Dislocation | Non-constrained in
Varus/Valgus |
|-------------------|-----------------------------|---------------------|------------------------------------|
| Capitello-Condyl. | Yes | No | No |
| Townley System | Yes | Yes | Yes |
The Townley Total Elbow Replacement ensemble is substantially equivalent to the Capitello-Condylar prosthesis manufactured by Johnson Orthopaedics. The two systems are identical relative to general purpose and concept of elbow replacement as well as the materials used. The only dissimilarity relates to certain details in implant designing that include: l ) allowance for a limited degree of varus/valgus excursion, 2) a modular polyethylene insert, 3) a snap-fitted prosthetic articulation, and 4) the right/left universability of the ulnar component. The two systems are equally proficient in allowing normal flexion and extension motion.