# K002996: Synergy HA Coated Porous Femoral  Stems

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 11, 2000 after 77 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
No predicates in its family tree.
203 later devices descend from it; 11 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Global Taper Tapered (Synergy) HA Hip Stem: named in the summary without a submission number
- (no number) Secur-Fit® HA Hip Stem: named in the summary without a submission number
- (no number) Omnifit® HA Hip Stem: named in the summary without a submission number
- (no number) Meridian® ST/PA Femoral Stem: named in the summary without a submission number
- (no number) APR Porous HA Hip System: named in the summary without a submission number

## Most influential descendants
- K030236: Acumatch P-Series Porous Press-Fit Femoral Component (2003), 146 descendants of its own
- K041906: Exactech 12/14 Total Hip System (2004), 145 descendants of its own
- K042842: Novation 12/14 Press-Fit Femoral Stem (2004), 64 descendants of its own
- K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene (2005), 60 descendants of its own
- K070479: Exactech Novation Crown Cup and Liners (2007), 59 descendants of its own

## Indications for use
Total hip components 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 non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Source page: https://510kreport.com/device/K002996
Methodology: https://510kreport.com/methodology