# K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia)

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Aug 27, 1999 after 212 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: 4 generations back to K933275 (1994). 23 ancestors in all.
9 later devices descend from it; 3 cite 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)
- K965002: Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and SL and, Encore Orthopedics, Inc. (1997) Summary page 1.
- K980081: S-Rom Zirconia Ceramic Femoral Hip Head, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K981847: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (1998) Summary page 1.
- K971409: Osteonics Alumina C-Taper Head, Osteonics Corp. (1997) Summary page 1.

## Most influential descendants
- K012918: Apex Modular Alumina Femoral Head (2001), 7 descendants of its own
- K101451: Apex Module Hip System Biolox Delta Femoral Head (2010), 4 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K042035: Alumina Head (2004), 1 descendant of its own

## Indications for use
The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedure where previous treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.

Source page: https://510kreport.com/device/K990261
Methodology: https://510kreport.com/methodology