(78 days)
The Global Shoulder - DePuy Inc., The Bio-Modular Total Shoulder - Biomet Inc ., Monospherical Shoulder Prosthesis - Howmedica Inc
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No
The document describes a mechanical orthopedic implant (shoulder humeral component) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a shoulder replacement component intended to treat painful and disabling joint diseases, aseptic necrosis, fractures, and dislocations of the shoulder, which are conditions requiring therapeutic intervention.
No
Explanation: The device is a humeral component intended for use in shoulder replacement surgery, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of Ti6Al4V alloy and cobalt chromium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that the Osteonics Shoulder Humeral Components are implantable devices used for surgical replacement of the shoulder joint. They are intended to be placed within the body, not used to test samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Use of reagents or assays.
- Providing diagnostic information based on laboratory tests.
Therefore, the Osteonics Shoulder Humeral Components are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Each Osteonics Shoulder Humeral Component consists of a humeral stem component and a mating humeral head component. Each device is a single-use device. The Osteonics® Shoulder Humeral Components are intended for cementless applications.
The Osteonics Shoulder Humeral Components may be used as a hemi- or as a total shoulder replacement device. If used as a hemi-shoulder replacement device, the Osteonics Shoulder Humeral Components are intended to articulate directly with the anatomic glenoid. If used as a total shoulder replacement device, the Osteonics" Shoulder Humeral Components are intended to articulate with the legally marketed Osteonics All Polyethylene Glenoid Shoulder Component.
The specific indications for the use of the Osteonics" Shoulder Humeral Components are as follows:
- . Aseptic necrosis of the humeral head.
- . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
Product codes
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Device Description
Each Osteonics Shoulder Humeral Component consists of an Osteonics Shoulder Humeral Stem and a mating Osteonics Shoulder Humeral Head.
The Osteonics" Shoulder Humeral Stems are available in a range of sizes, and are manufactured from Ti6Al4V alloy. They are characterized by the following features:
- Male Taper: The humeral stem components are affixed to the modular humeral head ー components by means of a male/female taper lock.
- Flanges: There are flanges on the anterior, posterior and lateral sides. -
- -Collar: The collar seats flush with the prepared proximal humerus. There are two collar designs.
- Proximal surface roughening: The surface of the proximal portion of the stem is grit blasted to enhance the cement/prosthesis interface.
- Distal Flats: The distal flats provide rotational stability. -
The Osteonics" Shoulder Humeral Heads feature a female taper design. The heads are available in a range of sizes and thicknesses. The heads feature a circular groove in the non-articulating underside of the component to prevent the components from being unnecessarily heavy. The humeral head components, which are manufactured from cobalt chromium alloy, will be available with or without nitrogen ion implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
The Osteonics® Shoulder Humeral Components Osteonics Corp. ., The Global Shoulder - DePuy Inc., The Bio-Modular Total Shoulder - Biomet Inc ., Monospherical Shoulder Prosthesis - Howmedica Inc
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
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
955731
MAR - 5 1996
Osteonics® Shoulder Humeral Components
510(k) Summary
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Shoulder Humeral Components
Submission Information
| Name and Address of the Sponsor
| of the 510(k) Submission: | Osteonics Corporation | |
|---|---|---|
| 59 Route 17 | ||
| Allendale, NJ 07401-1677 | ||
| Contact Person: | Terry Jarosz | |
| Regulatory Affairs Specialist | ||
| Date of Summary Preparation: | February 2, 1996 | |
| Device Identification | ||
| Proprietary Name: | Osteonics® Shoulder Humeral | |
| Components | ||
| Common Name: | Artificial shoulder humeral | |
| component | ||
| Classification Name and Reference: | Shoulder joint metal/polymer | |
| semi-constrained cemented | ||
| prosthesis | ||
| 21 CFR §888.3660 | ||
| Shoulder joint humeral (hemi- | ||
| shoulder) metallic uncemented | ||
| prosthesis | ||
| 21 CFR §888.3690 |
1
Predicate Device Identification
The Osteonics Shoulder Humeral Components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- The Osteonics® Shoulder Humeral Components Osteonics Corp. .
- The Global Shoulder - DePuy Inc.
- The Bio-Modular Total Shoulder - Biomet Inc .
- . Monospherical Shoulder Prosthesis - Howmedica Inc
Device Description
Each Osteonics Shoulder Humeral Component consists of an Osteonics Shoulder Humeral Stem and a mating Osteonics Shoulder Humeral Head.
The Osteonics Shoulder Humeral Stems:
The Osteonics" Shoulder Humeral Stems are available in a range of sizes, and are manufactured from Ti6Al4V alloy. They are characterized by the following features:
- Male Taper: The humeral stem components are affixed to the modular humeral head ー components by means of a male/female taper lock.
- Flanges: There are flanges on the anterior, posterior and lateral sides. -
- -Collar: The collar seats flush with the prepared proximal humerus. There are two collar designs.
- Proximal surface roughening: The surface of the proximal portion of the stem is grit blasted to enhance the cement/prosthesis interface.
- Distal Flats: The distal flats provide rotational stability. -
The Osteonics Shoulder Humeral Heads:
The Osteonics" Shoulder Humeral Heads feature a female taper design. The heads are available in a range of sizes and thicknesses. The heads feature a circular groove in the non-articulating underside of the component to prevent the components from being unnecessarily heavy. The humeral head components, which are manufactured from cobalt chromium alloy, will be available with or without nitrogen ion implantation.
Intended Use:
j
Each Osteonics Shoulder Humeral Component consists of a humeral stem component and a mating humeral head component. Each device is a single-use device. The Osteonics® Shoulder Humeral Components are intended for cementless applications.
2
The Osteonics Shoulder Humeral Components may be used as a hemi- or as a total shoulder replacement device. If used as a hemi-shoulder replacement device, the Osteonics Shoulder Humeral Components are intended to articulate directly with the anatomic glenoid. If used as a total shoulder replacement device, the Osteonics" Shoulder Humeral Components are intended to articulate with the legally marketed Osteonics All Polyethylene Glenoid Shoulder Component.
The specific indications for the use of the Osteonics" Shoulder Humeral Components are as follows:
- . Aseptic necrosis of the humeral head.
- . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
Statement of Technological Comparison:
The subject devices do not differ in terms of their intended uses from the predicate devices cited earlier in this summary. The subject devices utilize the same materials as one or more of the predicate devices cited above. The subject devices employ design features which are common to one or more of the predicate devices cited above. In addition, the Osteonics® Shoulder Humeral Heads in a version with a nitrogen ion implanted bearing surface can be found substantially equivalent because the use of Nitrogen ion implantation for cobalt chromium bearing surfaces has already been found substantially equivalent by FDA for both hip femoral bearing and knee femoral bearing surfaces.