(365 days)
No
The device description focuses on material changes and manufacturing location, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as an artificial joint replacement for the shoulder, intended to relieve pain and address conditions like fractures and avascular necrosis. These are all therapeutic purposes.
No
The device is a shoulder implant designed for the relief of pain or disability in the clenohumeral joint due to various conditions, or for the treatment of fractures and other complicated management problems. It is a prosthetic device for repair or replacement, not for diagnosing a condition.
No
The device description clearly describes physical implants made of metal alloys (Cobalt-Chromium-Molybdenum alloy, titanium alloy) intended for surgical implantation in the shoulder joint. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a surgical implant for treating conditions of the shoulder joint (clenohumeral joint, proximal humerus, humeral head). This is a therapeutic device used in vivo (within the body).
- Device Description: The device description details the physical components of a shoulder implant (stems, heads, glenoid components) made of metal alloys. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue), or to provide information for the diagnosis, prevention, or treatment of disease.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the clenohumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including falled reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.
Product codes
Not Found
Device Description
The Kirschner Shoulders are all based on the original design concept of the Neer Shoulder. Common design features include Cobalt-Chromium-Molybdenum alloy substrate: smooth. distally tapered stem; grooves in the stem to aid in cement pressurization and provided torsional stability; four proximal fins to provided rotational stability and facilitate positioning insertion; continuous radius of curvature humeral head geometry and; all humeral heads are compatible with all glenoid components. Kirschner II-C Humeral Stems are one piece in that the head and stern are an single component. Modular II-C Humeral Stems are a one piece stem with a modular head attached by a Morse-type taper. Atlas-C Modular Stems are two piece stems composed of a proximal humeral component and a distal stem attached by a screw thread. This component also utilizes a modular humeral head. The Modular Glenoid Metal Backing provides reinforcement to a polyethylene bearing surface. The design is identical to the predicate device.
This 510(k) is for a change from a cobalt alloy plasma spray coating to a titanium alloy coating and a change in the manufacturing location. All other aspects of the device remain the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clenohumeral joint, proximal humerus, 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)
Not Found
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.
K873073, K874643, K940537, K873104
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
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
1961261
APR -2 1997
感
CORPORATE HEA
- Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Kirschner Shoulders with Titanium Plasma Spray
Classification Name: non-constrained. metal/polvmer Prosthesis. shoulder. cemented and Prosthesis, shoulder, humeral (hemi-shoulder) metallic
Indications for Use: 1) Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the clenohumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including falled reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.
Device Description: The Kirschner Shoulders are all based on the original design concept of the Neer Shoulder. Common design features include Cobalt-Chromium-Molybdenum alloy substrate: smooth. distally tapered stem; grooves in the stem to aid in cement pressurization and provided torsional stability; four proximal fins to provided rotational stability and facilitate positioning insertion; continuous radius of curvature humeral head geometry and; all humeral heads are compatible with all glenoid components. Kirschner II-C Humeral Stems are one piece in that the head and stern are an single component. Modular II-C Humeral Stems are a one piece stem with a modular head attached by a Morse-type taper. Atlas-C Modular Stems are two piece stems composed of a proximal humeral component and a distal stem attached by a screw thread. This component also utilizes a modular humeral head. The Modular Glenoid Metal Backing provides reinforcement to a polyethylene bearing surface. The design is identical to the predicate device.
This 510(k) is for a change from a cobalt alloy plasma spray coating to a titanium alloy coating and a change in the manufacturing location. All other aspects of the device remain the same.
Image /page/0/Figure/7 description: The image shows the mailing address, shipping address, office number, fax number, and email address for a company. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587. The shipping address is Airport Industrial Park, Warsaw, IN 46580. The office number is 219.267.6639, the fax number is 219.267.8137, and the email address is biomet@biomet.com.
11
1
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Nerve damage
Blood vessel damage Soft tissue imbalance Delaved wound healing Metal sensitivitv Fracture of the components Disassociation of the modular head
Bone fracture Infection Hematoma Dislocation Excessive wear
1
17 11
Substantial Equivalence: In function and overall design, the Kirschner Shoulders with Titanium Plasma Spray are equivalent to almost all hip components on the market.
Devices are identical to the following predicate Kirschner products: Kirschner II-C Humeral Stems - K873073 Modular 11-C Humeral Stems - K874643 Atlas-C Modular Proximal Humeral Components - K940537 Modular Glenoid Metal Backing - K873104