# K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 19, 2012 after 177 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: 4 generations back to K932481 (1994). 4 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072852: SL-Plus Standard and Lateral Hip Stems, Smith & Nephew, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K111584: Xylos Macro-Porous Surgical Mesh, Xylos Corporation (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA (2013), 11 descendants of its own
- K122296: SL-Plus Mia Femoral Stems with TI/HA Coating (2012), 8 descendants of its own
- K143739: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA (2015), 7 descendants of its own
- K122244: Polarcup Dual Mobility System (2012), 5 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own

## Indications for use
The SL-PLUS0 Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head. The SL-PLUS0 Lateratized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion-

Source page: https://510kreport.com/device/K120211
Methodology: https://510kreport.com/methodology