# K122296: SL-Plus Mia Femoral Stems with TI/HA Coating

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 28, 2012 after 28 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: 5 generations back to K932481 (1994). 6 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082371: Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip Stem, Smith & Nephew, Inc. (2009) Summary page 1.
- K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 1.

## Most influential descendants
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K143096: SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA (2015), 3 descendants of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 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

## Indications for use
The SL PLUS* MIA Stem with and without Ti/HA is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease indluding rheumatoid arthritis, arthritis secondary to avariety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The SL PLUS0 MIA Stem with and without Ti/HA isfor single use only and isintended to be implanted without bone cement.

Source page: https://510kreport.com/device/K122296
Methodology: https://510kreport.com/methodology