MSS - Monobloc stem— 510(k) K250644
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K250644 for MSS - Monobloc stem, Substantially Equivalent on 2026-02-03. Applicant: Medacta International S.A.. Device class: 2.
Summary
Medacta International's MSS - Monobloc stem is filed under product code PHX (Shoulder Prosthesis, Reverse Configuration). The record doesn't describe the stem beyond its name and that code name.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Medacta filed from Castel San Pietro, Switzerland. The substantially equivalent decision came 336 calendar days after receipt (March 4, 2025 to February 3, 2026).
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Product code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code PHX
view allMore clearances from Medacta International S.A.
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K250644
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250644.
Data sourced from openFDA. This site is unofficial and independent of the FDA.