# K143096: SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 24, 2015 after 147 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: 6 generations back to K932481 (1994). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122296: SL-Plus Mia Femoral Stems with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 5.
- K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 5.

## Most influential descendants
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own
- K170473: C2 femoral stem (2017), 0 descendants of its own

## Indications for use
The SL-PLUS™ MIA Stem and the SL-PLUS™ MIA Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for: Indications Standard Stem The SL-PLUS MIA Hip Stem 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. Indications Lateral Stem The SL-PLUS MIA Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute) Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety 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. 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. The SL-PLUS™ Stem and the SL-PLUS™ Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for: Indications Standard Stem The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head Indications Lateral Stem The SL-PLUS Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute) Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety 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. 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/K143096
Methodology: https://510kreport.com/methodology