# K142187: Link MP Reconstruction Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Nov 6, 2014 after 90 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955296 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955296: Link MP Reconstruction Hip, Link America, Inc. (1996) Summary page 4.

## Most influential descendants
- K213675: MP Reconstruction System (2022), 0 descendants of its own
- K190181: Instruments for LINK MEGASYSTEM-C Family (2019), 0 descendants of its own

## Recalls of this device
- Dec 5, 2024 · Class II · Z-0769-2025: Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
- Dec 7, 2018 · Class II · Z-0733-2019: The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may

## Indications for use
The LINK® MP® Reconstruction Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The LINK® MP® Reconstruction Hip Prosthesis is indicated for the following conditions: 1) Revision arthroplasty due to juxta-articular bone defects. 2) 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. 3) Revision of loosened femoral prosthesis components by peri- / subprosthetic fracture. 4) Deformed proximal femur due to fractures or osteotomies. 5) Correction of bone deficiencies, e.g. due to tumors. 6) Large post-revision and post-trauma segmental bone defects. The LINK® MP® Reconstruction Prosthesis is for cementless use only.

Source page: https://510kreport.com/device/K142187
Methodology: https://510kreport.com/methodology