(84 days)
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No
The description focuses on patient-specific design based on bone geometry and engineering analysis, with no mention of AI or ML terms or processes.
Yes
The device is a Patient Specific Implant (PSI) for total hip arthroplasty, indicating it is intended to replace or restore a damaged hip joint, which is a therapeutic function.
No
Explanation: The device is a patient-specific implant for total hip arthroplasty, designed to replace a damaged hip joint. Its purpose is therapeutic (replacement of damaged tissue), not diagnostic.
No
The device description clearly states it is a "hip femoral component," which is a physical implant, not software. The summary also describes mechanical testing and stress analysis of this physical component.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that the PSI device is a femoral component used in total hip arthroplasty (THA). This is a surgical implant designed to replace a damaged hip joint.
- Intended Use: The intended use is to replace the hip joint, not to perform diagnostic tests on biological samples.
- Device Description: The device is a physical implant, not a test kit, reagent, or instrument used for analyzing samples.
- Input: The input is imaging data (CT or X-Ray) used for designing the implant, not biological samples for analysis.
The device is a surgical implant designed for direct use within the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The PSI device is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.
Product codes
87 LZO
Device Description
The Kalros™ Orthopaedics Patient Specific Implant (PSI) hip femoral component is designed using the patient's natural bone geometry to construct an implant to better fit and fill the patient's femoral canal relative to other commercially available standard hip stems. Since each stem is matched to a particular patient, a precise device description cannot be provided, as the device design will vary from patient depending upon their unique, naturally occurring bone geometry. Kairos™ Orthopaedics specifies eight design parameters that define an "envelope" of dimensional limits within which all PSI stems are defined.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT or X-Ray
Anatomical Site
hip femoral component
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Additionally, an engineering stress analysis was performed on the envelope of design parameters to ensure fatigue performance of the PSI femoral component comparable to a clinically proven standard hip stem. Mechanical testing performed by Kairos ™Orthopaedics on a representative PSI stem verified these stress analysis calculations.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
JAN 27 1997
Premarket Notification 510(k) Summary
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act (SMDA) of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) Summary for the Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component.
| Submitter: | Kairos™ Orthopaedics
819 Striker Avenue, Suite 10
Sacramento, California 95834
Telephone: (916) 646-5403
Fax: (916) 646-5432 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 1, 1996 |
| Contact Person: | Brian Cleary
Director, Regulatory Affairs |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis (21 CFR
888.3353) |
| Common Name: | Patient Matched Hip Stem |
| Trade/Proprietary Name: | Patient Specific Implant (PSI) Hip Femoral Component |
| Product Code: | 87 LZO |
Device Description:
The Kalros™ Orthopaedics Patient Specific Implant (PSI) hip femoral component is designed using the patient's natural bone geometry to construct an implant to better fit and fill the patient's femoral canal relative to other commercially available standard hip stems. Since each stem is matched to a particular patient, a precise device description cannot be provided, as the device design will vary from patient depending upon their unique, naturally occurring bone geometry. Kairos™ Orthopaedics specifies eight design parameters that define an "envelope" of dimensional limits within which all PSI stems are defined.
The PSI device is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.
1
Substantial Equivalence:
Several commercially available standard line hip products are substantially equivalent to the Kairos™ Orthopaedics' PSI hip femoral component with respect to overall design, materials, intended use, and sterilization methods. Additionally, the manufacturing methods and applied surface treatments are substantially the same as those used in the production of a wide range of currently marketed standard line hip products.
It is our understanding that other anatomically based hip stems have received 510(k) clearance in the past, including the following:
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- Patient Matched Implant (PMI) Hip Femoral Component Biomet, Inc. (Warsaw, Indiana)
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- Techmedica CAD/CAM Custom Hip Techmedica, Inc. (Camarillo, California)
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- Biopro DRG Custom Hip Replacement System Biopro, Inc. (Port Huron, Michigan)
Of these. Biomet's Patient Matched Implant (PMI) is the most similar and is still presently marketed. Biomet's PMI hip stem is also a patient matched hip stem which uses patient data to design and manufacture a hip stem to match a particular patient's naturally occurring bone geometry. Due to the similarities in the general device design concept, Kairos™ Orthopaedics believes that the Biomet PMI stem is ideal for comparison to demonstrate the substantial equivalence of Kairos™ Orthopaedics' PSI stem. The table on the following page summarizes these feature comparisons.
Additionally, an engineering stress analysis was performed on the envelope of design parameters to ensure fatigue performance of the PSI femoral component comparable to a clinically proven standard hip stem. Mechanical testing performed by Kairos ™Orthopaedics on a representative PSI stem verified these stress analysis calculations.
2
Feature comparisons between the Kairos™ Orthopaedics PSI hip femoral component and Biomet, Inc. PMI hip femoral component. Differences are indicated in bold print.
| Subject Device | Predicate Device | |
|---|---|---|
| Characteristics | Kairos ™ Orthopaedics | Biomet, Inc. |
| Patient Specific Implant (PSI) | Patient Matched Implant (PMI) | |
| Manufacturer | Kairos™ Orthopaedics | Biomet, Inc. |
| 510(k) Approved | - | Yes |
| Materials | Wrought or Forged Titanium | |
| (Ti-6Al-4V) | Wrought Cobalt Chromium | |
| (Co-Cr-Mo) or Wrought | ||
| Titanium (TI-6Al-4V) | ||
| Intended Use | Uncemented | Cemented/Uncemented |
| Patient Matched | Yes | Yes |
| Collar | Yes | Yes |
| Distal Flutes | Yes | Yes |
| Surface Treatments | • Smooth | |
| • Grit Blasted | • Smooth | |
| • Grit Blasted | ||
| • Plasma Sprayed Coating | ||
| • Ion Nitride (NTS) | ||
| Stem Length from | ||
| Resection Level | 90mm - 300mm | unknown |
| Distal Diameter | 8mm - 20mm | unknown |
| Patient Information | CT or X-Ray | CT or X-Ray |
| Sterilization Status | Sterile & Non-sterile | Sterile |
.....