(87 days)
Not Found
No
The document describes a physical medical device (a hip stem) and its intended use and design features. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
Yes
The device is described as an artificial hip stem intended to replace the anatomy of the femur in total hip or hemi-hip replacement, addressing conditions like avascular necrosis, osteoarthritis, and rheumatoid arthritis, which are therapeutic interventions.
No
The device is a medical implant (a hip stem) used for replacing parts of the femur, not for diagnosing conditions.
No
The device description clearly describes a physical implant (a hip stem) made of CoCr, with specific design features and intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant, specifically a femoral stem for hip replacement surgery. It is a physical device intended to be surgically implanted into the body.
- Intended Use: The intended use is to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. This is a surgical procedure, not an in vitro test.
The description clearly indicates a device used in vivo (within the living body) for surgical reconstruction, not a test performed in vitro (outside the living body) on a sample.
N/A
Intended Use / Indications for Use
The Natural-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, ostooarthritis and inflammatory joint disease (JJD), e.g., rheumatoid arthritis.
-
- Those patients with failed previous surgery where pain, deformity or dysfunction persiss.
- Revision of previously failed arthroplasty. 3.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
Product codes
Not Found
Device Description
The Natural-Hip System CoCr Stem is a straight stem employing a proximal wedge shaped design. The stem is available in both a collarless design. The proximal one-third of the stem's surface is grit blasted. Normalization steps are also located on the proximal portion of the stem. The grit blasted surface and normalization steps enhance cement compression and bonding for optimal fixation of the hip stern in the femoral canal.
The Natural-Hip System CoCr Stem employs a Sulzer 12/14 configured neck trumion for attachment to Intermedics Orthopedics, Inc.'s femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured bore.
The Natural-Hip System CoCr Stem has a hole in the distal portion of the stem to allow the use of a distal centralizer for correct distal alignment. The stern also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. This device is intended for single use only.
The Natural-Hip System CoCr Stem is intended to be used in conjunction with the following Intermedics Orthopedics, Inc. devices that have been cleared for marketing by the FDA:
- IOI metallic femoral bearing heads [510(k)s K905781 and K913060],
- IOI Biolox Bearing Heads [510(k)s K923734, K942330],
- I Zirconia Bearing Heads [510(k) K944209],
- IOI bipolar components [510(k)s K833404 and K873815],
- IOI unipolar components [510(k)s K833403 and K934159],
- IOI acetabular components [510(k)s K850793, K920955, K933203, K942406, K941617, K955033 and K955739].
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.
The Natural-Hip System - DRG Hip Stem (Intermedics Orthopedics, Inc.), the Premier Hip Stem (Intermedics Orthopedics, Inc.), the ODC Hip Stem (Osteonics Corporation), and the Perfecta IMC Stem (Orthomet 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.
K905781, K913060, K923734, K942330, 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
JAN 27 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 64 35"
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Mcdical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Naural-Hip™ System CoCr Stem.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|
| Date: | January 14, 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 Stem |
PRODUCT DESCRIPTION
The Natural-Hip System CoCr Stem is a straight stem employing a proximal wedge shaped design. The stem is available in both a collarless design. The proximal one-third of the stem's surface is grit blasted. Normalization steps are also located on the proximal portion of the stem. The grit blasted surface and normalization steps enhance cement compression and bonding for optimal fixation of the hip stern in the femoral canal.
The Natural-Hip System CoCr Stem employs a Sulzer 12/14 configured neck trumion for attachment to Intermedics Orthopedics, Inc.'s femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured bore.
The Natural-Hip System CoCr Stem has a hole in the distal portion of the stem to allow the use of a distal centralizer for correct distal alignment. The stern also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. This device is intended for single use only.
The Natural-Hip System CoCr Stem is intended to be used in conjunction with the following Intermedics Orthopedics, Inc. devices that have been cleared for marketing by the FDA:
- 에 IOI metallic femoral bearing heads [510(k)s K905781 and K913060],
- 트 IOI Biolox Bearing Heads [510(k)s K923734, K942330],
- I Zirconia Bearing Heads [510(k) K944209],
- 해 IOI bipolar components [510(k)s K833404 and K873815],
- 에 IOI unipolar components [510(k)s K833403 and K934159],
1
- IOI acetabular components [510(k)s K850793, K920955, K933203, K942406, K941617, 리 K955033 and K955739].
DIAGNOSTIC INDICATIONS
The Natural-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, ostooarthritis and inflammatory joint disease (JJD), e.g., rheumatoid arthritis.
-
- Those patients with failed previous surgery where pain, deformity or dysfunction persiss.
- Revision of previously failed arthroplasty. 3.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
SUBSTANTIAL EQUIVALENCE
The Natural-Hip System CoCr Stem is substantially equivalent to the Natural-Hip System - DRG Hip Stem (Intermedics Orthopedics, Inc.), the Premier Hip Stem (Intermedics Orthopedics, Inc.), the ODC Hip Stem (Osteonics Corporation), and the Perfecta IMC Stem (Orthomet Inc.).