# K143739: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 20, 2015 after 111 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: 6 generations back to K932481 (1994). 8 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA, Smith & Nephew, Inc. (2013) Summary page 4.

## Most influential descendants
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K240381: CATALYSTEM Femoral Stems (2024), 1 descendant of its own
- K250571: CATALYSTEM Femoral Stems (2025), 0 descendants of its own
- K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (2024), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own

## Recalls of this device
- Jul 22, 2020 · Class II · Z-2827-2020: Multiple lots being recalled due to a product design issue

## Indications for use
The POLARSTEM Collared and Valgus Stem with Ti/HA (INTEGRATION-PLUS™) is 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.

Source page: https://510kreport.com/device/K143739
Methodology: https://510kreport.com/methodology