(67 days)
The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty.
The general indications associated with the use of DRG Stem in total hip arthroplasty include:
-
- Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
- ni Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- র প Revision of previously failed arthroplasty.
The DRG Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented toral hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometty for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown.
Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater 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 DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA).
This is a 510(k) premarket notification for a hip stem, outlining its intended use, design features, and comparison to predicate devices. It is a medical device submission, not a study describing AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI device.
The provided text describes:
- Device: Natural Hip System - DRG Hip Stem (femoral component of a total hip prosthesis).
- Manufacturer: Intermedics Orthopedics, Inc. (IOI).
- Intended Use: To replace the anatomy of the femur in cases of total hip replacement, for cemented or cementless (press-fit) application in total hip arthroplasty. Indications include inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis, rheumatoid arthritis), failed previous surgery, and revision of previously failed arthroplasty.
- Technological Characteristics: A detailed comparison of the DRG Hip Stem's material, intended use (cemented/cementless), proximal wedge-shaped design, proximal collar availability, surface enhancement via grit blasting, distal canal centralizer, neck lengths, and sizes against several predicate hip stems.
The document does not contain information on acceptance criteria or a study related to an AI/algorithm device. It is a regulatory submission for a physical medical implant. Therefore, I cannot provide a response for the requested information points, as they are not applicable to the provided text.
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11 15 1996
长961999
ಸಂಸ್ಕೃತಿಯರ ವಿಧಾರಿಸಿದೆ. ನಿರ್ವಹಿಸಿದ
510(k) Premarket Notification Summary of Safety and Effectiveness for Natural Hip System - DRG Hip Stem
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 DRG Hip Stem.
| Submitter: | Intermedics Orthopedics, Inc. (IOI)9900 Spectrum DriveAustin, Texas, 78717Tel.: (512) 432-9900Fax: (512) 432-9291 | ||||
|---|---|---|---|---|---|
| Contact Person: | Regarding this submission:Name: Sam MirzaTel.: 512-432-9751Fax: 512-432-9291 | ||||
| Official CorrespondentName: Jacquelyn HughesTel.: 512-432-9687Fax.: 512-432-9291 | |||||
| Date: | May 21, 1996 | ||||
| Proprietary name | Natural Hip System - DRG Hip Stem | ||||
| Common Name: | Total Hip Prosthesis - Femoral Component | ||||
| Classification name: | Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21CFR 888.3353). | ||||
| Predicate Devices: | The features employed by the DRG Hip Stem are substantiallyequivalent to the features employed by the following predicate legallymarketed devices: | ||||
| Premier Total Hip Stem: Intermedics Orthopaedics Inc.(510(k) #K894051). Osteonics ODC Cemented Hip Stem: Osteonics Corporation(510(k) number unknown to IOI). Osteonics ODC Hip Stem: Osteonics Corporation (510(k)number unknown to IOI). |
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JUL- 2-96 - 7-96 - 2 - 2 - 2 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FAX NO. 5128736291
P. 06
Perfecta IMC Stem: Orthomet Inc. (510(k) number unknown to I()I .
The DRG Hip Stem employs a Sulzer 12/14 configured threaded Device Description: trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented toral hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometty for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown.
Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater 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 DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA).
The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty .
The general indications associated with the use of DRG Stem in total hip arthroplasty include:
-
- Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
- ni Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- র প Revision of previously failed arthroplasty.
Intended Use:
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Summary of Technological Characteristics:
A side by side tabular comparison of the characteristics of the DRG Hip Stem to those of the currently marketed IOI and competitive devices follows
| SubjectDevice | Predicate Devices | ||||
|---|---|---|---|---|---|
| Characteristics | DRGHip Stem | PremierTotal HipStem | ODC FxHip Stem | ODC HipStem | PerfectaIMCStem |
| Manufacturer | IOI | IOI | Osteonics | Osteonics | Orthomet |
| 510(k)# | K894051 | Unknown | Unknown | Unknown | |
| Material | Wrought orForged CoCr | Titaniumalloy | Cast CoCr | Cast CoCr | ForgedCoCralloy |
| Intended Use | Cemented/Cementless | Cemented | Cemented | Cemented | Cemented |
| Proximal wedgeshaped design | Yes | Yes | Yes | Yes | Yes |
| Proximal collar | Availablewith orwithoutcollar | Yes | Yes | Yes | Yes |
| SurfaceEnhancementVia Grit Blasting | Entire lengthbelow thecollar of thehip stem | Proximalthird only | Entire lengthbelow thecollar | Proximal thirdonly | Proximalthird only |
| Distal CanalCentralizer | Yes | Yes | No | Yes | Yes |
| Neck Lengths | 25-41mm | 35mm | 25-35mm | 25-40mm | Unknown |
| Sizes | 5 sizes | 7 sizes | 5 sizes | 7 sizes | 6 sizes |
N/A