# K130365: X-Alt Highly Cross Linked VE Acetabular Liner

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Sep 23, 2013 after 222 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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: 7 generations back to K810258 (1981). 30 ancestors in all.
38 later devices descend from it; 7 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072154: Foundation (FMP) Porous Coated Spiked Acetabular System, Encore Medical L.P. (2007) Summary page 1.
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 1.

## Most influential descendants
- K141006: RSP Humeral Socket Insert (2014), 21 descendants of its own
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (2017), 18 descendants of its own
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K140830: Exprt Revision Knee (2014), 7 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 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. This device is intended for cementless use only

Source page: https://510kreport.com/device/K130365
Methodology: https://510kreport.com/methodology