# K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 10, 2013 after 206 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932481 (1994). 7 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 1.
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 1.
- K953111: Corail, Landos, Inc. (1996) Summary page 2.

## Most influential descendants
- K143739: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA (2015), 7 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K240381: CATALYSTEM Femoral Stems (2024), 1 descendant of its own
- K160011: H-Max S stem (2016), 1 descendant of its own
- K250571: CATALYSTEM Femoral Stems (2025), 0 descendants of its own

## Recalls of this device
- Jul 24, 2017 · Class II · Z-3100-2017: The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

## Indications for use
The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are Indicated for * Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. * Fracture or avascular necrosis of the femoral head * Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesls. hemiarthropiasty, surface replacement arlhroplasty. or total hip replacement "All forms of osteoarthritis "Patients with hips at risk of dislocation * Femoral neck fracture or proximal fracture to hip joint The POLARSTEM Standard and Lateral Femoral Stem with TI/HA is intended for single use only and isto be Implanted without bone cement.

Source page: https://510kreport.com/device/K130728
Methodology: https://510kreport.com/methodology