(82 days)
No
The description focuses on the material, design, and mechanical features of a revision hip stem, with no mention of AI or ML.
Yes
The device is intended for use in the "treatment" of various joint diseases and revision of failed surgeries, which aligns with the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
The device is a CoCr Revision Stem intended to replace part of the femur in hip replacement surgeries, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is fabricated from cobalt chromium alloy and describes physical features like a threaded neck trunnion, collared/collarless design, and a bowed distal portion. This indicates a physical implant, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided text describes a surgical implant intended to replace a part of the femur in hip replacement surgery. It is a physical device implanted inside the body.
- Intended Use: The intended use clearly states it's for replacing anatomy in total hip or hemi-hip replacement and for revision of failed arthroplasty. This is a surgical procedure, not a diagnostic test performed on a specimen.
The description focuses on the material, design, and surgical application of the device, which are characteristic of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Natural-Hip System CoCr Revision Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Revision Stem is intended for cemented application only and is intended for single use only. The Natural-Hip System CoCr Revision Stem is intended for use in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- Revision of previously failed arthroplasty.
Product codes
Not Found
Device Description
The Natural-Hip System CoCr Revision Stem is fabricated from either forged or wrought cobalt chromium alloy which conforms to the American Standards for Testing and Materials (ASTM) standards F-799 or F-1537, respectively.
The Natural-Hip System CoCr Revision Stem features a threaded Sulzer 12/14 configured neck trunnion for attachment to IOI's currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore.
The Natural-Hip System CoCr Revision Stem is available in both a collared and collarless design. The proximal one-third of the stem's surface employs normalization steps and is roughened via the process of grit blasting. The normalization steps and grit blasted surface enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The proximal surface of the Natural-Hip System CoCr Revision Stem also employs polymethylmethacrylate (PMMA) cement centralizers to provide even cement mantle when the stem is implanted in the femur.
The distal portion of the Natural-Hip System CoCr Revision Stem is bowed to mimic the anatomy of the femur. The Natural-Hip System CoCr Revision Stem employs a hole in the distal portion of the stem to allow the use of a PMMA centralizer for correct distal alignment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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.
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.
K905781, K9130601, K923734, K9423301, K944209, K833404, K873815, K833403, K934159, K850793, K920955, K933203, K942406, K941617, K955033, K955739
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
19770166
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Natural-Hip™ System CoCr Revision Stem.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 | APR - 8 1997 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | January 15, 1997 | |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs | |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
non-porous uncemented prosthesis, 21 CFR 888.3353. | |
| Common/Usual Name: | Total Hip Prosthesis - Femoral Component | |
| Trade/Proprietary Name: | Natural-Hip™ System CoCr Revision Stem | |
| Device Description: | The Natural-Hip System CoCr Revision Stem is fabricated from
either forged or wrought cobalt chromium alloy which conforms
to the American Standards for Testing and Materials (ASTM)
standards F-799 or F-1537, respectively. | |
| | The Natural-Hip System CoCr Revision Stem features a threaded
Sulzer 12/14 configured neck trunnion for attachment to IOI's
currently marketed femoral heads, including Biolox and Zirconia
heads, employing a Sulzer 12/14 configured bore. | |
| | The Natural-Hip System CoCr Revision Stem is available in both
a collared and collarless design. The proximal one-third of the
stem's surface employs normalization steps and is roughened via
the process of grit blasting. The normalization steps and grit
blasted surface enhance cement compression and bonding for
optimal fixation of the hip stem in the femoral canal.
The
proximal surface of the Natural-Hip System CoCr Revision Stem
also employs polymethylmethacrylate (PMMA) cement
centralizers to provide even cement mantle when the stem is
implanted in the femur. | |
| | The distal portion of the Natural-Hip System CoCr Revision Stem
is bowed to mimic the anatomy of the femur. The Natural-Hip | |
System CoCr Revision Stem employs a hole in the distal portion
1
of the stem to allow the use of a PMMA centralizer for correct distal alignment.
The Natural-Hip System CoCr Revision Stem is intended to be used in conjunction with the following Intermedics Orthopedics, Inc. (IOI) devices that have been cleared for marketing by the FDA:
- IOI metallic femoral bearing heads [510(k)s K905781 and 트 K9130601.
- IOI Biolox Bearing Heads [510(k)s K923734 and ■ K9423301
- Zirconia Bearing Heads [510(k) K944209], 에
- 트 IOI bipolar components [510(k)s K833404 and K873815],
- IOI unipolar components [510(k)s K833403 트 and K934159],
- I IOI acetabular components [510(k)s K850793, K920955, K933203, K942406, K941617, K955033 and K955739].
The Natural-Hip System CoCr Revision Stem is intended to Diagnostic Indications replace the anatomy of the femur in cases of total hip or hemi-hip The Natural-Hip System CoCr Revision Stem is replacement. intended for cemented application only and is intended for single use only. The Natural-Hip System CoCr Revision Stem is intended for use in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint 1. disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, 2. deformity or dysfunction persists.
-
- Revision of previously failed arthroplasty.
Predicate Devices: The features employed by Natural-Hip System CoCr Revision Stem are substantially equivalent to the features employed by the following predicate legally marketed devices:
- 트 Osteonics Corporation [510(k) Omnifit® Long Stem: number unknown to IOI].
- Ultima® Long Stem: Johnson & Johnson Professional Inc. [510(k) K952859].
- I PCA® Long Stem: Howmedica Inc. [510(k) number unknown to IOI].
- Matrix Cementra® Revision Femoral Stem: Smith & Nephew Richards [510(k) Number unknown to IOI}.