Natural Porous Hip System
510(k) K913060
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913060 | Date11 Oct 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Natural Porous Hip System is a Prosthesis, Hip, Semi-constrained, Metal/Polymer designed for cemented total hip or hemi-hip arthroplasty. It features a porous coating to enhance osseointegration, providing structural support and stability in revision or primary hip replacements. The system is available in collared and collarless configurations to accommodate varying clinical needs. Its semi-constrained design balances mobility and stability for patients requiring hip joint reconstruction.
This device is supplied as a cemented implant, intended for surgical use in orthopedic settings. It is classified under FDA product code JDI and was cleared via a Traditional 510(k) pathway (K913060) in 1991, with subsequent updates (e.g., K960258). The system is not described as single-use or reusable in regulatory filings, though sterility and handling per surgical protocols apply. No MRI safety or size-specific storage instructions are noted in the available data.
Other devices from Intermedics Orthopedics
Questions
AI-generated answers, 1 Oct 2026
What is the Natural Porous Hip System used for?
The Natural Porous Hip System is designed for cemented total hip or hemi-hip arthroplasty, serving as a structural replacement for damaged hip joints. Its semi-constrained metal/polymer design balances mobility and stability, making it suitable for both primary and revision surgeries. The porous coating promotes osseointegration, ensuring long-term fixation and support.
How is the Natural Porous Hip System supplied and intended for use?
This device is supplied as a cemented implant intended exclusively for surgical use in orthopedic settings. It is not described as single-use or reusable in regulatory filings, meaning it must be handled according to standard surgical protocols to maintain sterility and functionality. The system is not intended for non-surgical applications or self-administration.
Are there different configurations available for the Natural Porous Hip System?
Yes, the Natural Porous Hip System is available in two configurations: collared and collarless. These variations accommodate different clinical needs, allowing surgeons to choose based on patient anatomy, stability requirements, and the specific demands of the procedure—whether primary or revision.
What regulatory pathway was followed for the Natural Porous Hip System?
The Natural Porous Hip System was cleared via the Traditional 510(k) pathway (K913060) by the FDA in 1991 under product code JDI, with subsequent updates (e.g., K960258). The device was determined to be substantially equivalent to a legally marketed predicate, ensuring compliance with orthopedic implant standards at the time of clearance.
Are there any special storage instructions for the Natural Porous Hip System?
The available data does not specify any unique MRI safety or size-specific storage instructions for the Natural Porous Hip System. However, as with all surgical implants, it should be stored in a clean, dry environment protected from contamination until use, following standard surgical protocols to preserve sterility and integrity.