# K042252: Nexflex Total Hip System

- Pathway: 510(k) (Special)
- Applicant: Alphatec/Nexmed
- Decided: Dec 6, 2004 after 108 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K990369 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033580: Nexflex Total Hip System, Nexmed, Inc. (2004) Summary page 2.
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000) Summary page 2.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 2.

## Indications for use
1) When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant. 2) When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant. 3) In addition, the NexFlex MT Total Hip System is intended for cases where alternative modes of treatment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure.

Source page: https://510kreport.com/device/K042252
Methodology: https://510kreport.com/methodology