# K990369: Synergy Cemented Hip Stem

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 12, 1999 after 32 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 8 cite it directly.
0 of 24 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” Hip Stem - Smith & Nephew: named in the summary without a submission number
- (no number) Zimmer Versys® Hip Stem - Zimmer: named in the summary without a submission number
- (no number) Wright Perfecta IMC™ Hip Stem - Wright Medical: named in the summary without a submission number
- (no number) Spectron Extra Small Straight Femoral Component - Smith & Nephew: named in the summary without a submission number
- (no number) DePuy AML® Hip Stem - DePuy: named in the summary without a submission number

## Most influential descendants
- K111546: U2 Hip System (2011), 13 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own

## Indications for use
Total hip components are indicated for cemented 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 (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/K990369
Methodology: https://510kreport.com/methodology