# K141327: Minima S System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Aug 6, 2014 after 77 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 177 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 183 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112091: H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 5.
- K972791: Encore Linear Hip, Encore Orthopedics, Inc. (1998) Summary page 5.
- K991325: Modification of Encore Linear Porous Coated Hip, Encore Orthopedics, Inc. (1999) Summary page 5.
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 4.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 5.
- K883460: Focus Total Hip System, Depuy, Inc. (1988) Summary page 6.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 6.
- K130899: Biolox Delta Ceramic Femoral Heads, Zimmer GmbH (2013) Summary page 6.
- K100412: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2010) Summary page 6.
- K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 6.

## Most influential descendants
- K143509: MasterSL femoral stem (2015), 3 descendants of its own
- K150855: H-MAX S Femoral Hip System (2015), 2 descendants of its own
- K160011: H-Max S stem (2016), 1 descendant of its own
- K231925: MINIMA S System (2023), 0 descendants of its own
- K170473: C2 femoral stem (2017), 0 descendants of its own

## Indications for use
The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: x non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; x rheumatoid arthritis; x treatment of femoral head and neck fractures; x revisions in cases of good remaining femoral bone stock.

Source page: https://510kreport.com/device/K141327
Methodology: https://510kreport.com/methodology