# K000392: Response 2000 Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 24, 2000 after 77 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
No predicates in its family tree.
29 later devices descend from it; 1 cites it directly.
0 of 30 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) DePuy Quantum Hip Stem: named in the summary without a submission number
- (no number) DePuy Modular Press-Fit (MPF) Hip (Std. & MMA): named in the summary without a submission number
- (no number) DePuy Vision AML Hip Stems: named in the summary without a submission number
- (no number) DePuy AML MMA Hip Stem: named in the summary without a submission number

## Most influential descendants
- K030122: Depuy Summit Basic Press-Fit Hip Stem (2003), 28 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own
- K193398: Summit DuoFix HA Coating (2020), 20 descendants of its own
- K202472: ACTIS Duofix Hip Prosthesis (2020), 15 descendants of its own
- K210581: Actis DuoFix Hip Prosthesis- Collarless (2021), 13 descendants of its own

## Indications for use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Non Porous-Coated Press-Fit or Cemented Components: Non Porous-coated femoral hip stem prostheses labeled "FOR PRESS-FIT OR CEMENTED USE" are indicated for press-fit uncemented use, or for use with bone cement.

Source page: https://510kreport.com/device/K000392
Methodology: https://510kreport.com/methodology