Latitud Hip Replacement System
by Meril Healthcare Pvt., Ltd.
510(k) K222436
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222436 | Date9 May 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPH
- FDA applicant
- Meril Healthcare Pvt. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Latitud Hip Replacement System is an uncemented orthopedic implant designed for total hip arthroplasty. It features modular components for acetabular and femoral reconstruction, providing a range of sizes and configurations to address degenerative joint disease, fractures, or congenital hip deformities. The system is engineered to promote osseointegration and long-term stability without the use of bone cement. Its modularity allows for customisation to match anatomical variations, improving fit and functional outcomes for patients.
The system is supplied sterile and intended for single-use in controlled surgical environments. It is classified under FDA product code LPH and has received a Traditional 510(k) clearance (K222436) as substantially equivalent to a predicate device. Components are MRI-unsafe due to metallic construction and must be handled with appropriate sterile techniques. Storage requires adherence to manufacturer guidelines to preserve sterility and integrity until use.
Other devices from Meril Healthcare Pvt., Ltd.
Questions
AI-generated answers, 20 Sep 2026
What types of hip conditions is the Latitud Hip Replacement System intended to address in patients?
The Latitud Hip Replacement System is designed for patients with degenerative joint disease, fractures, or congenital hip deformities requiring total hip arthroplasty. Its modular components allow for customization to fit anatomical variations, making it suitable for a range of complex hip reconstructions where stability and osseointegration are critical.
Is the Latitud Hip Replacement System reusable, or is it meant for single-use only?
The Latitud Hip Replacement System is explicitly supplied sterile and intended for single-use in controlled surgical environments. This ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks.
How should the Latitud Hip Replacement System be stored to maintain sterility and functionality?
The system must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. Since it is supplied sterile and intended for single-use, it should remain in its original packaging until use, protected from contamination, moisture, or physical damage.
Can the Latitud Hip Replacement System be used in patients who require MRI scans after surgery?
No, the Latitud Hip Replacement System is MRI-unsafe due to its metallic construction. Patients implanted with this system should avoid MRI procedures, as the metal components could cause heating, artifacts, or other risks during imaging.
What distinguishes the Latitud Hip Replacement System from other uncemented hip implants?
The Latitud system’s key feature is its modularity, offering customizable acetabular and femoral components to match anatomical variations. This design promotes osseointegration without cement, aiming for long-term stability and improved functional outcomes for patients with degenerative disease, fractures, or congenital deformities.