# K023302: Echelon Porous Plus HA Hip Stems

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 25, 2002 after 22 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 1 generation back to K971206 (1998). 2 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000) Summary page 1.
- K971206: Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating, Howmedica Corp. (1998) Summary page 1.
- (no number) Osteoimplant Technology, Inc. LSF HA Coated Triad Total Hip System (fixnod stems): named in the summary without a submission number

## Most influential descendants
- K032683: Genesis II Porous Plus HA Knee System (2003), 19 descendants of its own
- K100897: Legion Porous + HA Tibial Baseplates (2010), 12 descendants of its own
- K211221: Porous Patella and Porous Tibia Baseplate (2021), 5 descendants of its own
- K190577: World Knee Total Knee Systems (2019), 5 descendants of its own
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own

## Indications for use
Total hip componmts are indicated for uncemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (N1DID)or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended dminase-fiee period; non-union; femoral neck fracture and trochanteric fractures of the proximal femurwith head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Echelob Porous Plus H A Hip Stem components are intended uncemented use for single use only.

Source page: https://510kreport.com/device/K023302
Methodology: https://510kreport.com/methodology