# K213770: SP-CL Hip Stem and LCU Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Sep 13, 2022 after 285 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: 15 generations back to K941847 (1994). 176 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161840: LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated, Waldemar Link GmbH & Co. KG (2017) Summary page 4.

## Indications for use
The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The hip systems are 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/K213770
Methodology: https://510kreport.com/methodology