# K110400: Taperloc Complete Microplasty Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Sep 30, 2011 after 231 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850055 (1985). 50 ancestors in all.
34 later devices descend from it; 9 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101086: Taperloc Complete, Biomet, Inc. (2010) Summary page 2.
- K062994: Lateralized Taperloc Microplasty Femoral Components, Biomet Manufacturing Corp (2007) Summary page 2.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 2.
- K071723: Zimmer Porolock Mis Stem, Zimmer GmbH (2008) Summary page 2.

## Most influential descendants
- K120030: Taperloc Complete Size 4MM and XR 123 (2012), 14 descendants of its own
- K121034: Ioi Total Hip (2012), 11 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K131279: Iconacy I-Hip System (2013), 8 descendants of its own
- K132572: I-Hip Total Hip System (2014), 7 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous coated components are intended for uncemented biological fixation.

Source page: https://510kreport.com/device/K110400
Methodology: https://510kreport.com/methodology