Lfic or Fetto Hip
by Zimmer, Inc.
510(k) K952776
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952776 | Date14 Feb 1996 | 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- Withdrawn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
- LWJ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The LFIC Fetto Hip Prosthesis is a semi-constrained, uncemented hip joint femoral prosthesis designed to replace a portion of the hip joint. It features a metal femoral component, typically constructed from cobalt-chromium-molybdenum alloys, paired with a polymer component to facilitate articulation and stability within the hip joint.
This device is intended for surgical implantation and is classified under product code LWJ as a Prosthesis, Hip, Semi-constrained, Metal/Polymer. Supplied sterile for single-use, it was cleared by the FDA under 510(k) K952776 in 1996, adhering to traditional review standards. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 19 Sep 2026
What type of hip prosthesis is the LFIC Fetto Hip, and how does its design differ from other hip replacements?
The LFIC Fetto Hip is a semi-constrained, uncemented femoral prosthesis, meaning it relies on bone ingrowth for stability rather than adhesive cement and allows limited movement to reduce stress on surrounding tissues. It consists of a metal femoral component (typically cobalt-chromium-molybdenum alloy) paired with a polymer articulation surface, designed to replace part of the hip joint while maintaining flexibility and durability.
Is this device meant for repeated use in the same patient, or is it intended for single-use only?
The LFIC Fetto Hip is sterile and supplied for single-use only. Like most implantable medical devices, it is not designed for reuse or reprocessing, and adherence to sterile handling protocols is critical to ensure patient safety and device integrity before implantation.
How should the LFIC Fetto Hip be stored to maintain its sterility and functionality?
The device must be stored according to sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging, away from moisture, extreme temperatures, or contamination, until ready for surgical use. Always follow the manufacturer’s instructions for storage conditions to avoid compromising sterility or performance.
What materials are used in the construction of the LFIC Fetto Hip, and why is this important?
The LFIC Fetto Hip features a metal femoral component made from cobalt-chromium-molybdenum alloy, paired with a polymer articulation surface. These materials are chosen for their durability, biocompatibility, and wear resistance, which help ensure long-term stability and reduce the risk of complications like loosening or wear debris in the hip joint.
How was the FDA clearance for this device determined, and what does that mean for its regulatory status?
The LFIC Fetto Hip was cleared by the FDA under 510(k) K952776 in 1996 through a traditional review process, with a determination of substantial equivalence (SESE) to a predicate device. This means the FDA found it to be as safe and effective as a previously cleared hip prosthesis, but it does not imply ongoing approval—only that it met the regulatory requirements at the time of clearance.