(62 days)
The S-ROM Hip System - Locking Plug has the same indications for use as the S-ROM Hip System - Locking Pin. They are both indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from:
- rheumatoid arthritis.
- osteoarthritis,
- post-traumatic arthritis,
- collagen disorders,
- avascular necrosis, and
- nonunion of femoral fractures.
Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with: - congenital hip dysplasia,
- protrusio acetabuli.
- slipped capital femoral epiphysis,
- and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Locking Plug consists of a head and body. The head has both internal threading and external serrations (barbs). The internal threading allows attachment of the insertion tool to the Locking Plug. The body is cylindrical with an external lip. Both the external serrations of the head and the lip of the Locking Plug body aid in resisting disengagement of the Locking Plug from the shell/liner assembly. The Locking Plug is available in both 3.5 mm and 5.0 mm sizes.
Here's an analysis of the provided text regarding acceptance criteria and supporting study information:
Based on the provided text, there is no information available about acceptance criteria or a study proving that the device meets specific performance criteria. The document focuses entirely on establishing substantial equivalence for the S-ROM Hip System - Locking Plug to previously marketed devices.
Therefore, I cannot populate the table or answer most of your questions based only on the provided input.
However, I can extract the information that is present:
Context of the Document:
- Device: S-ROM Hip System - Locking Plug
- Manufacturer: Johnson & Johnson Professional, Inc.
- Regulatory Submission Type: Summary of Safety and Effectiveness Data for a 510(k) (indicated by K963206)
- Primary Goal of Document: To demonstrate substantial equivalence to predicate devices (Locking Pin currently marketed under #K870271 and K924492).
Key Points from the Document Regarding Substantial Equivalence:
- Material: Same material (Ti-6Al-4V Titanium Alloy) as the predicate device.
- Intended Use: The same as the predicate device (total hip replacement for various conditions).
- Design: Stated to be "substantially equivalent" to the predicate.
- Manufacture: Stated to be "substantially equivalent" to the predicate.
- Packaging: Same as the predicate device.
- Sterilization: Same as the predicate device.
Absence of Specific Performance Testing:
The provided text does not contain:
- A table of acceptance criteria.
- Reported device performance metrics (e.g., strength, durability, wear rates, clinical success rates).
- Any description of a study (clinical or non-clinical) designed to demonstrate performance against specific criteria.
- Information on sample sizes, ground truth establishment, expert qualifications, or adjudication methods related to performance assessment.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
Conclusion:
This document is a regulatory submission focused on demonstrating substantial equivalence for a medical device by showing it is similar in design, materials, and intended use to a legally marketed predicate device. In a 510(k) pathway, direct clinical performance studies proving specific acceptance criteria are often not required if substantial equivalence can be established through other means (like comparison to a predicate device and bench testing, though no bench testing details are provided here).
Therefore, the requested information regarding acceptance criteria and studies proving the device meets them cannot be provided from this specific text because it is not present.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.