# K062994: Lateralized Taperloc Microplasty Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 9, 2007 after 158 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: 2 generations back to K921301 (1994). 3 ancestors in all.
84 later devices descend from it; 5 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050441: Taper 2 Porous Femoral Stem, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K072417: Smith & Nephew Mis Hip Stem (2008), 44 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K080625: Smith & Nephew Mis Hip Stem with Stiktite (2008), 19 descendants of its own
- K103256: Smith & Nephew SMF Hip Stem (2011), 16 descendants of its own
- K083312: Minihip Stem (2010), 15 descendants of its own

## Indications for use
The Lateralized Taperloc® Microplasty TM Femoral Components are indicated for use in patients requiring hip replacement due to the following: 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 of previously failed femoral head resurfacing component The Lateralized Taperloc® Microplasty TM Femoral Components are intended for uncemented use only. Specific indications for compatible components that can be used with the Lateralized Taperloc® Microplasty TM femoral Components include: Constrained Liners (K030047) Constrained liners are intended for general use inskeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K062994
Methodology: https://510kreport.com/methodology