# K183141: LINK MP Monoblock Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Feb 8, 2019 after 87 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973837 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973837: CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SL, Sulzer Orthopedics, Inc. (1998) Summary page 4.

## Most influential descendants
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own

## Recalls of this device
- Jul 3, 2023 · Class II · Z-2354-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2346-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2349-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2348-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2350-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2347-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2356-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2353-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2352-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2345-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2351-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif
- Jul 3, 2023 · Class II · Z-2355-2023: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modif

## Indications for use
The LINK® MP® Monoblock is indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures The LINK® MP® Monoblock is indicated for the following conditions: - Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone the fixation of a new standard prosthesis is not possible - Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture The device is intended for cementless use.

Source page: https://510kreport.com/device/K183141
Methodology: https://510kreport.com/methodology