# K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: May 10, 2012 after 288 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 K921308 (1994). 67 ancestors in all.
13 later devices descend from it; 6 cite it directly.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000521: Keystone Hip, Encore Orthopedics, Inc. (2000) Summary page 3.
- K041114: Profemur Tapered Hip Stem, Wrightmedicaltechnologyinc (2004) Summary page 3.
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 3.
- K032380: Wagner Cone Prosthesis, Centerpulse Orthopedics, Inc. (2003) Summary page 3.
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;, Encore Medical L.P. (2010) Summary page 3.
- K883460: Focus Total Hip System, Depuy, Inc. (1988) Summary page 3.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 3.
- K992153: PE-Plus Acetabular Cup, Plus Orthopedics (1999) Summary page 3.
- K030153: Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32, Zimmer, Inc. (2003) Summary page 3.
- K023743: Smith & Nephew Global Bipolar System, Smith & Nephew, Inc. (2003) Summary page 3.
- K953510: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis, Encore Orthopedics, Inc. (1995) Summary page 3.
- K974093: Foundation Porous Coated Hemispherical Shell, Encore Orthopedics, Inc. (1998) Summary page 2.
- K974095: Foundation Porous Coated Flared Rim Shell, Encore Orthopedics, Inc. (1998) Summary page 2.
- K973119: Foundation Porous Acetabular System, Encore Orthopedics, Inc. (1998) Summary page 2.
- K023794: Constrained Liner, Encore Medical L.P. (2003) Summary page 2.
- K072154: Foundation (FMP) Porous Coated Spiked Acetabular System, Encore Medical L.P. (2007) Summary page 2.

## Most influential descendants
- K141327: Minima S System (2014), 5 descendants of its own
- K152903: REVIVAL (TM) Modular Revision Hip Stem (2016), 4 descendants of its own
- K140975: Mastersl Femoral Stem (2014), 4 descendants of its own
- K191374: Revival Modular Hip Stem (2019), 3 descendants of its own
- K143509: MasterSL femoral stem (2015), 3 descendants of its own

## Indications for use
The MODULUS stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Modulus Stems are intended for use with Co-Cr-Mo femoral heads and a compatible acetabular cup. When used in partial hip arthroplasty, the Modulus Stems are intended for use with the 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: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; * rheumatoid arthritis; * osteoarthritis after femoral heads fractures; * correction of functional deformity; * revisions in cases of good remaining femoral bone stock. The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

Source page: https://510kreport.com/device/K112158
Methodology: https://510kreport.com/methodology