# K001982: Tri-Lock Hip Stem

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 26, 2000 after 27 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
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 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) Tri-Lock Hip Stem: named in the summary without a submission number

## Most influential descendants
- K010367: Modification to Titanium Tri-Lock Hips Stem (2001), 31 descendants of its own
- K121563: Corin Trifit TS Hip (2012), 10 descendants of its own
- K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (2016), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own
- K153381: Corin Metafix Hip Stem (2016), 5 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 arthrifis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. TFailed previous hip surgery including joint reconmstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or .fotal ~hip replacement. 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K001982
Methodology: https://510kreport.com/methodology
