# K210062: Mectaplug PE II

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 8, 2021 after 87 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941847 (1994). 170 ancestors in all.
No later device cites it as a predicate yet.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021765: Cement Restrictor, Small and Large, Exactech, Inc. (2002) Summary page 4.
- K800144: Femoral Cement Restrictor, Biomet, Inc. (1980) Summary page 4.
- K791125: Plug-Lok Cement Restirctor, Richard'S Medical Equip., Inc. (1979) Summary page 4.
- K192827: Quadra-P, Medacta International S.A. (2020) Summary page 4.
- K131310: GMK Full PE Tibial Components, Medacta International (2013)

## Indications for use
MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery. Total hip arthroplasty is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia * Avascular necrosis of the femoral head * Acute traumatic fracture of the femoral head or neck * Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty Partial hip arthroplasty is indicated in the following cases: * Acute traumatic fracture of the femoral head or neck * Non-union of femoral neck fracture * Avascular necrosis of the femoral head * Primary pathology involving the femoral head, but with a non-defonned acetabulum

Source page: https://510kreport.com/device/K210062
Methodology: https://510kreport.com/methodology