# K120030: Taperloc Complete Size 4MM and XR 123

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Aug 17, 2012 after 226 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: 7 generations back to K850055 (1985). 51 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 66 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.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 2.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) Summary page 2.

## Most influential descendants
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K210678: implaFit® hip stems (2022), 3 descendants of its own
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant 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/K120030
Methodology: https://510kreport.com/methodology