# K130099: Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Jun 21, 2013 after 157 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: 2 generations back to K991325 (1999). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974294: Encore Linear Porous Coated Hip, Encore Orthopedics, Inc. (1998) Summary page 1.
- K081679: Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05, Encore Medical L.P. (2008) Summary page 2.
- K120241: Linear Hip Stem, Size 5, Encore Medical L.P. (2012) Summary page 2.

## Most influential descendants
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K161610: EXPRT Revision Hip System (2016), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own
- K163497: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt (2017), 0 descendants of its own

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head * Rheumatoid arthritis * Correction of functional deformity * Femoral fracture This device may also be indicated in the salvage of previously failed surgical attempts. The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered. This stem is to be press-fit. This stem is intended for cementless use.

Source page: https://510kreport.com/device/K130099
Methodology: https://510kreport.com/methodology