# K161840: LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Mar 16, 2017 after 254 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941847 (1994). 175 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123991: Depuy Corail Amt Hip Prosthesis, Depuy France S.A.S. (2013) Summary page 4.
- K070554: Depuy Corail Amt Dysplasia Hip Prosthesis, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 4.
- K854465: Link Contour Ribbed Hip Prostheses System, Link America, Inc. (1986) Summary page 4.

## Most influential descendants
- K213770: SP-CL Hip Stem and LCU Hip System (2022), 0 descendants of its own

## Indications for use
The LINK® SP-CL® and LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated is indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The hip system is indicated for the following conditions: - Primary and secondary coxarthrosis - Osteoarthritis - Necrosis of the femoral head - Femoral neck fractures The stems are indicated for cementless use only.

Source page: https://510kreport.com/device/K161840
Methodology: https://510kreport.com/methodology