# K103755: Taperloc Complete, Size 5 and 6

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Jan 21, 2011 after 29 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: 1 generation back to K101086 (2010). 1 ancestor in all.
48 later devices descend from it; 8 cite it directly.
0 of 50 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.

## Most influential descendants
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K121935: Taperset Hip Small Stems (2012), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K120030: Taperloc Complete Size 4MM and XR 123 (2012), 14 descendants of its own
- K121034: Ioi Total Hip (2012), 11 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/K103755
Methodology: https://510kreport.com/methodology