# K241483: ceramys™ femoral head system

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Feb 7, 2025 after 259 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
Longest line of descent: 8 generations back to K810258 (1981). 28 ancestors in all.
1 later device descends 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)
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve, Encore Medical L.P. (2008) Summary page 5.

## Most influential descendants
- K251833: EMPOWR Acetabular® Liner Extension (2025), 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 EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks. 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.

Source page: https://510kreport.com/device/K241483
Methodology: https://510kreport.com/methodology