(87 days)
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. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persiss. Revision of previously failed arthroplasty. 3.
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.
This document is a 510(k) summary for a medical device (Natural-Hip™ System CoCr Stem), not a study report or clinical trial outcome document. Therefore, it does not contain the information required to answer your questions about acceptance criteria and study details.
The provided text focuses on:
- Device Description: What the device is, its materials, design features, and intended use.
- Intended Use/Indications: The medical conditions it's designed to address and how it's used (e.g., cemented application).
- Substantial Equivalence: Listing similar devices already on the market to establish that this new device is just as safe and effective.
There is no information in this document about:
- Acceptance criteria and reported device performance: This document does not describe specific performance metrics or thresholds for success.
- Sample size and data provenance: No study data is presented.
- Number and qualifications of experts for ground truth: Not applicable as no ground truth establishment is mentioned.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (this device is a physical implant, not an AI algorithm).
- How ground truth for the training set was established: Not applicable.
In essence, this document is a regulatory submission for a physical orthopedic implant seeking clearance based on its similarity to existing devices, not a report detailing the results of a diagnostic performance study.
§ 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.