(82 days)
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.
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.
This is a 510(k) summary for a medical device, specifically a hip joint replacement component. It does not describe any AI/ML device or software, therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.
The document discusses the physical characteristics, intended use, and predicate devices for a "Natural-Hip™ System CoCr Revision Stem." It is purely about the hardware of a hip implant.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment because this document does not pertain to an AI/ML device.
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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 DriveAustin, Texas 78717(512) 432-9900 | APR - 8 1997 |
|---|---|---|
| Date: | January 15, 1997 | |
| Contact Person: | Jacquelyn HughesManager, Regulatory Affairs | |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented ornon-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 fromeither forged or wrought cobalt chromium alloy which conformsto the American Standards for Testing and Materials (ASTM)standards F-799 or F-1537, respectively. | |
| The Natural-Hip System CoCr Revision Stem features a threadedSulzer 12/14 configured neck trunnion for attachment to IOI'scurrently marketed femoral heads, including Biolox and Zirconiaheads, employing a Sulzer 12/14 configured bore. | ||
| The Natural-Hip System CoCr Revision Stem is available in botha collared and collarless design. The proximal one-third of thestem's surface employs normalization steps and is roughened viathe process of grit blasting. The normalization steps and gritblasted surface enhance cement compression and bonding foroptimal fixation of the hip stem in the femoral canal.Theproximal surface of the Natural-Hip System CoCr Revision Stemalso employs polymethylmethacrylate (PMMA) cementcentralizers to provide even cement mantle when the stem isimplanted in the femur. | ||
| The distal portion of the Natural-Hip System CoCr Revision Stemis bowed to mimic the anatomy of the femur. The Natural-Hip |
System CoCr Revision Stem employs a hole in the distal portion
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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.
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- 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}.
§ 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.