# K043537: Taperloc 12/14 Taper Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jan 14, 2005 after 23 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: 3 generations back to P960047 (1997). 24 ancestors in all.
160 later devices descend from it; 20 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components, Biomet, Inc. (2003) Summary page 1.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.
- K830313: Cfe Total Hip Femoral Component, Biomet, Inc. (1983) Summary page 1.
- K960984: SHP Hip System-Femoral Components/Acetabular Components/Modular Heads/Centralizers, Biomet, Inc. (1996) Summary page 1.
- K011110: M2A Acetabular System, Biomet, Inc. (2001) Summary page 1.
- K030047: Freedom Constrained Liners, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), 20 descendants of its own
- K121935: Taperset Hip Small Stems (2012), 20 descendants of its own

## Indications for use
The Taperloc' 12/14 Taper Femoral Components and M a-38TM Modular Heads are indicated for use in cemented or non-cemented total hip replacement in cases of: 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 joint replacement. The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or 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/K043537
Methodology: https://510kreport.com/methodology