(71 days)
intended for use in internal fixation of small bones-primarily the distal radius in the forearm.
a series of titanium plates and screws with plates of T configurations and varying lengths. The system is intended for use in internal fixation of small bones-primarily the distal radius in the forearm. These plates are attached to bone using 2.7 mm diameter titanium bone. All screws are fully threaded and self-tapping with cross-slotted heads.
This 510(k) summary for the R.R.P.S. Radius Reconstruction Plating System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The provided text is a regulatory submission summary that establishes substantial equivalence to already marketed devices. It focuses on:
- Device Identification: Proprietary name, common name, classification, regulatory class, product code.
- Contact Information.
- Device Description: What the device is (titanium plates and screws for distal radius fixation).
- Substantial Equivalence Claim: Basis for equivalence (intended use, design, materials, operating principles) to predicate devices (Alta® Modular Trauma Small Bone Plating System, Synthes® Small Fragment and Mini Set).
Therefore, I cannot provide the requested information in a table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. These details would typically be found in the full submission, not in this 510(k) summary.
In the context of a 510(k) submission like this, "acceptance criteria" for a medical device usually relate to performance specifications that demonstrate the device is as safe and effective as a legally marketed predicate device. This often involves mechanical testing (e.g., fatigue strength, pull-out strength for screws, bending strength of plates) rather than clinical studies with human subjects, especially for a device establishing substantial equivalence to existing technology. If clinical performance was a key differentiating factor, a clinical study would be required, but it's not described here.
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19616
JUN 2 8 1996
Device: R. R. P. S. Radius Reconstruction Plating System
510(k) SUMMARY
| Proprietary Name: | R. R. P. S. Radius Reconstruction Plating System |
|---|---|
| Common Name: | Small Bone Plating System |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone FixationAppliances and Accessories 888.3030 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87HRS |
| For information contact: | Frank MaasManager, Regulatory AffairsHowmedica Inc.359 Veterans BoulevardRutherford, NJ 07070 |
| Telephone: | (201)-507-7875 |
| Fax: | (201)-507-6870 |
The R. R. P. S. Radius Reconstruction Plating System is a series of titanium plates and screws with plates of T configurations and varying lengths. The system is intended for use in internal fixation of small bones-primarily the distal radius in the forearm. These plates are attached to bone using 2.7 mm diameter titanium bone. All screws are fully threaded and self-tapping with cross-slotted heads.
The substantial equivalence of these devices is based on equivalence in intended use, design, materials and operating principles to several legally marketed devices including the Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.) and the Synthes® Small Fragment and Mini Set (Synthes USA).
N/A