(176 days)
No
The device description focuses on the mechanical design, materials, and surgical application of a hip replacement system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a total hip replacement system, used to treat conditions like noninflammatory degenerative joint disease and inflammatory joint disease, and aims to provide significant improvement in the quality of life for patients. These indications clearly define it as a therapeutic device designed to alleviate disease and improve health.
No.
The device described is a total hip replacement system, which is a prosthetic implant used for surgical intervention in patients with degenerative or inflammatory joint diseases. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components of a hip replacement system, including stems, trunnions, bearing heads, collars, and centralizers, all of which are hardware.
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 clearly describes a device for treating joint diseases and revising failed arthroplasties. This involves surgical implantation and addresses structural issues within the body.
- Device Description: The description details the physical components of a total hip replacement system (stems, trunnions, bearing heads, etc.) and how they are designed for surgical implantation and mechanical function within the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
In summary, this device is a surgical implant designed to replace or revise a hip joint, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
-
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous 2. surgery where pain, deformity, or dysfunction persists.
-
- Revision of previously failed arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient (see "Warnings and Precautions"), and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate of hip mobility leads to need an expectation of significant improvement in the quality of their lives.
Product codes
Not Found
Device Description
The components of the Natural Hip System employ an IOI 12/14 -Morse Taper configured trunnion, available in either threaded or smooth (non-threaded) configuration, for the attachment of the IOI's femoral bearing heads, including the zirconia bearing heads. The IOI 12/14 Morse Taper configured trunnion has previously been determined substantially equivalent by the FDA via the 510(k) #K913060. In addition, the use of zirconia bearing heads with the IOI 12/14 Morse Taper configured trunnion have also previously been determined substantially equivalent by the FDA via 510(k) #s' K942330 and K942406. Please note that the components of the Natural Hip System with a smooth Morse Taper configured trunnion are not intended to be used with the ceramic bearing heads. Such warning will be clearly stated on the IOI package insert accompanying the component the Natural Hip System (See of IOI's package insert provided proposed in Appendix A of this 510 (k) premarket notification submission).
The components of the Natural Hip System are available with and without a proximal collar. The proximal collar enhances cement pressurization in a cemented total hip arthroplasty. The components of the Natural Hip System incorporate a wedged shaped geometry on the proximal area of the hip stem for enhanced fit of the device in a prepared femoral canal. The wedge shaped geometry is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown. The components of the Natural Hip System are available with or without normalizations in the proximal anterior and posterior regions of the hip stem. Normalizations are series of steps and walls which potentially reduce subsidence and medial migration. In addition, the proximal region of the components of the Natural Hip System are available with or without proximal polymethylmethacryalte (PMMA) spacers which provide an even cement mantle in a cemented total hip arthroplasty.
Surface enhancement via grit blasting is employed on either the proximal third or the entire length of the hip stem below the collar of the components of the Natural -Hip System. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. The grit blasted surfaces provide a surface roughness of 63-149u-inches. In a cemented application, the grit blasted surface provides greater cement interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.
The distal portion of the components of the Natural Hip System employs a hole for the attachment of a distal centralizer fabricated from UHMWPe. The distal centralizer has been previously determined substantially equivalent by the FDA via 510(k) #K913208.
The components of the Natural Hip System available in 9 sizes (sizes are 00 through 7).
The components of the Natural Hip System, like the predicate IOI and competitive devices, are intended for cemented application. In addition, the components of the Natural Hip System are intended for cementless application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
K913060, K942330, K942406, K913208
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular 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.
0
K9600258 JUL 12 1996
Intermedics Orthopedics, Inc.
510(k) Premarket Notification Submission: Natural Hip System
510 (k) Premarket Notification Summary of Safety and Effectiveness for the Natural Hip System
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 components of the Natural Hip System.
Submitter:
Intermedics Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas, 78717 Tel.: (512) 432-9900 Fax: (512) 432-9291
Contact Person:
Jacquelyn Hughes Manager, Requlatory Affairs
Date:
Proprietary name:
Common Name:
Predicate Devices:
Natural Hip System
Artificial hip component
January 17, 1996
Common Name:
Classification name:
Class III
Tm
Prosthesis, Hip. Semi-constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous UnCemented Prosthesis 21CFR 888.3353).
The features employed by the components of the Natural System Hip are substantially equivalent to the features employed by the following legally marketed predicate devices:
- Premier Total Hip Stem: Intermedics Orthopaedics Inc. (510(k) #K894051).
- 그 Osteonics ODC Cemented Hip Stem: Osteonics Corporation (510(k) number unknown to IOI).
- 1 Osteonics ODC Hip Stem: Osteonics Corporation (510(k)nown to IOI).
- 1 PFC Cemented Hip Stem: Johnson & Johnson Orthopaedics (510(k) number unknown to IOI).
I
87 MAY
1
Intermedics Orthopedics, Inc.
Device Description:
1
Perfecta IMC Stem: Orthomet Inc. (510(k) number unknown to IOI).
The components of the Natural Hip System employ an IOI 12/14 -Morse Taper configured trunnion, available in either threaded or smooth (non-threaded) configuration, for the attachment of the IOI's femoral bearing heads, including the zirconia bearing heads. The IOI 12/14 Morse Taper configured trunnion has previously been determined substantially equivalent by the FDA via the 510(k) #K913060. In addition, the use of zirconia bearing heads with the IOI 12/14 Morse Taper configured trunnion have also previously been determined substantially equivalent by the FDA via 510(k) #s' K942330 and K942406. Please note that the components of the Natural Hip System with a smooth Morse Taper configured trunnion are not intended to be used with the ceramic bearing heads. Such warning will be clearly stated on the IOI package insert accompanying the component the Natural Hip System (See of IOI's package insert provided proposed in Appendix A of this 510 (k) premarket notification submission).
The components of the Natural Hip System are available with and without a proximal collar. The proximal collar enhances cement pressurization in a cemented total hip arthroplasty. The components of the Natural Hip System incorporate a wedged shaped geometry on the proximal area of the hip stem for enhanced fit of the device in a prepared femoral canal. The wedge shaped geometry is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown. The components of the Natural Hip System are available with or without normalizations in the proximal anterior and posterior regions of the hip stem. Normalizations are series of steps and walls which potentially reduce subsidence and medial migration. In
2
addition, the proximal region of the components of the Natural Hip System are available with or without proximal polymethylmethacryalte (PMMA) spacers which provide an even cement mantle in a cemented total hip arthroplasty.
Surface enhancement via grit blasting is employed on either the proximal third or the entire length of the hip stem below the collar of the components of the Natural -Hip System. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. The grit blasted surfaces provide a surface roughness of 63-149u-inches. In a cemented application, the grit blasted surface provides greater cement interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.
The distal portion of the components of the Natural Hip System employs a hole for the attachment of a distal centralizer fabricated from UHMWPe. The distal centralizer has been previously determined substantially equivalent by the FDA via 510(k) #K913208.
The components of the Natural Hip System available in 9 sizes (sizes are 00 through 7).
The components of the Natural Hip System, like the predicate IOI and competitive devices, are intended for cemented application. In addition, the components of the Natural Hip System are intended for cementless application.
The Indications for Use for the components of the Natural Hip System are as follows:
Intended Use:
3
-
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous 2. surgery where pain, deformity, or dysfunction persists.
-
- Revision of previously failed arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient (see "Warnings and Precautions"), and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate of hip mobility leads to need an expectation of significant improvement in the quality of their lives.
Summary of Technological Characteristics:
The features of the components of the Natural Hip System are substantially equivalent to the aforementioned predicate IOI and/or competitive devices in terms of materials, intended use and design characteristics. A comparison of the features of the components of the Natural Hip System in terms of materials, intended use and design characteristics to the aforementioned legally marketed predicate devices is as follows:
Materials:
Substantial equivalence in terms of materials is based upon the fact that both the subject devices and the legally marketed predicate devices are fabricated from either cobalt chromium alloy or titanium alloy.
IV
4
Intended Use:
The components of the Natural Hip System, like the predicate IOI and competitive devices, are intended for cemented application. The components of the differ from Natural Hip System the legally marketed predicate devices in they that are also intended for cementless application. The subject devices and the predicate devices share the same indications for use. Therefore, in terms of intended use the components Natural -Hip System of the are substantially equivalent to the legally marketed predicate devices.
Design characteristics:
The design characteristics of the components of the Natural Hip System are substantially equivalent to the predicate devices based upon the following;
- The components of the Natural Hip System like the aforementioned legally marketed predicate devices incorporate a wedged shaped geometry on the proximal area of the hip stem enhanced fit in a prepared for femoral canal.
- 1 The components of the Natural Hip System like the predicate IOI's Premier Total Hip stem and Orthomet's Perfecta IMC Stem are available with the optional normalizations on the proximal third of the femoral stem
- The components of the Natural Hip System like the predicate Osteonics' ODC Hip Stem and the ODC Fx Hip Stem are available without the optional normalizations on the proximal third of the femoral stem
- The components of the Natural Hip System like the aforementioned legally marketed predicate devices are available with proximal collar.
V
5
Please note that the components of Natural Hip System are also the available, as an option to the surgeon, without the the proximal collar.
- The components of the Natural Hip System like the predicate legally marketed IOI's Premier Total Hip Stem, Osteonics' ODC Hip Stem, Johnson & Johnson's PFC Cemented Hip Stem, and the Orthomet's Perfecta IMC Stem are available with the distal PMMA centralizer.
- The components of the Natural Hip System like the predicate legally marketed predicate IOI's . Premier Total Hip Stem, Osteonics ODC Hip Stem, Johnson Johnson's
PFC Cemented Stem, Hip and the Orthomet's Perfecta IMC Stem employ grit blasted surface on the proximal third the femoral of stem. In addition, the components of the Natural -System, Hip like the predicate Osteonics' ODC Fx Hip Stem, are available as an option with a grit blasted surface along the entire length below the collar of the hip stem.
Therefore, in terms of design characteristics the components of the Natural Hip System are substantially equivalent to the legally marketed predicate devices. Marketing literature on the aforementioned predicate devices is provided in Appendix D of this 510(k) premarket notification submission.
A side by side tabular comparison of the features of the components of the Natural Hip System to those of the predicate devices follows.
6
| Subject Devices | Predicate Devices | |||||
|---|---|---|---|---|---|---|
| Characteristics | The components | |||||
| of the Natural | ||||||
| Hip System | Premier | |||||
| Total Hip | ||||||
| Stem | ODC Fx | |||||
| Hip Stem | ODC Hip | |||||
| Stem | PFC | |||||
| Cemented | ||||||
| Hip Stem | Perfecta | |||||
| IMC | ||||||
| Stem | ||||||
| Manufacturer | IOI | IOI | Osteonics | Osteonics | J & J | Orthomet |
| 510(k)# | - | K894051 | Unknown | Unknown | Unknown | Unknown |
| Material | Cast CoCr/ | |||||
| Forged CoCr/ | ||||||
| Titanium alloy | Titanium | |||||
| alloy | Cast CoCr | Cast CoCr | CoCr | |||
| alloy | Forged | |||||
| CoCr | ||||||
| alloy | ||||||
| Application | Cemented/ | |||||
| Cementless | Cemented | Cemented | Cemented | Cemented | Cemented | |
| Proximal | ||||||
| anterior/posterior | ||||||
| normalization. | Available with or | |||||
| without | ||||||
| normalizations | Yes | No | No | No | Yes | |
| Proximal wedge | ||||||
| shaped design | Yes | Yes | Yes | Yes | Yes | Yes |
| Proximal PMMA | ||||||
| centralizers | Available with or | |||||
| without PMMA | ||||||
| centralizers | No | No | No | Yes | No | |
| Distal PMMA | ||||||
| centralizers | Yes | Yes | No | Yes | Yes | Yes |
| Proximal collar | Available with or | |||||
| without collar | Yes | Yes | Yes | Yes | Yes | |
| Surface | ||||||
| enhancement | ||||||
| via grit blasting | Proximal third or | |||||
| entire length | ||||||
| below the collar | ||||||
| of the hip stem | Yes, but | |||||
| proximal | ||||||
| third only | Yes, hip | |||||
| stem | ||||||
| below the | ||||||
| collar | Yes, but | |||||
| proximal | ||||||
| third only | Yes, but | |||||
| proximal | ||||||
| third only | Yes, but | |||||
| proximal | ||||||
| third only | ||||||
| neck lengths | 25-41mm | 35mm | 25-35mm | 25-40mm | unknown | Unknown |
| sizes | 9 sizes | 7 sizes | 5 sizes | 7 sizes | 5 sizes | 6 sizes |
.