ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
by Meril Healthcare Pvt., Ltd.
510(k) K171320
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171320 | Date8 Mar 2018 | 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- Withdrawn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
- HRS
- FDA applicant
- Meril Healthcare Pvt. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The device is a system of orthopedic plates and screws designed for fracture fixation and reconstructive surgery. It includes small fragment plates, calcaneal plates, humerus and olecranon plates, tibia and buttress plates, 2.4mm plates, clavicle hook plates, and metaphyseal plates, each used with MBOSS/FIXION screws.
The system is supplied non-sterile and intended for reuse after appropriate cleaning and sterilization by the healthcare facility. It received FDA 510(k) clearance (K171320) as substantially equivalent to a predicate device, with product code HRS and advisory committee classification OR (Orthopedic).
Other devices from Meril Healthcare Pvt., Ltd.
Questions
AI-generated answers, 19 Sep 2026
Are these plates and screws intended for single-use or can they be reused in a clinical setting?
These devices are not single-use. The system is explicitly supplied non-sterile and designed for reuse after proper cleaning and sterilization by the healthcare facility. This approach aligns with the device’s FDA 510(k) clearance, which does not restrict reuse when following appropriate reprocessing protocols.
What types of fractures or surgical procedures are these plates and screws primarily used for?
The ARMAR/ARTIS system includes specialized plates (e.g., small fragment, calcaneal, humerus, olecranon, tibia, buttress, clavicle hook, and metaphyseal) paired with MBOSS/FIXION screws. These are designed for fracture fixation and reconstructive orthopedic surgery, covering distal radius, calcaneus, humerus, olecranon, tibia, clavicle, and metaphyseal regions. The exact clinical application depends on the plate type, but all are intended for stabilizing bone fragments during surgical repair.
How is the device’s regulatory pathway described, and what does that mean for purchasing or use?
The device received FDA 510(k) clearance (K171320) under the Traditional 510(k) pathway, classified under product code HRS (Orthopedic) with an OR (Orthopedic) advisory committee. This means it was deemed substantially equivalent to a predicate device already on the market, confirming its compliance with U.S. regulatory standards for orthopedic fixation systems. Purchasers can rely on this clearance as evidence of safety and effectiveness for its intended surgical uses.
What storage conditions should be followed for these plates and screws before first use or after sterilization?
Since the system is supplied non-sterile, it must be cleaned and sterilized by the healthcare facility before use. After sterilization, the plates and screws should be stored in a clean, dry environment to prevent contamination. The manufacturer does not specify storage conditions beyond ensuring proper handling to maintain sterility and functionality, so adherence to standard orthopedic reprocessing protocols (e.g., ethylene oxide or autoclave) is recommended.
Are there different sizes or models available within this system, and how do they differ?
Yes, the ARMAR/ARTIS system includes multiple plate types, each tailored to specific anatomical regions or fracture patterns. For example, the 2.4mm plates are likely designed for smaller bones or finer fixation, while calcaneal plates and clavicle hook plates address distinct surgical needs. The MBOSS/FIXION screws are compatible across all plates, ensuring versatility. Exact sizing (e.g., length, hole configurations) would depend on the specific plate model, but the system’s variety allows surgeons to select the appropriate hardware for the procedure.