# K110290: Exeter Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 27, 2011 after 238 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955033 (1996). 20 ancestors in all.
37 later devices descend from it; 7 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011623: Exeter Hip System with V40 Taper, Howmedica Osteonics Corp. (2001) Summary page 2.
- K972228: Meridian Titanium Femoral Stems, Howmedica, Inc. (1997) Summary page 2.
- K993601: Howmedica Osteonics Femoral Heads, Howmedica Osteonics Corp. (1999) Summary page 2.
- K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 2.
- K061434: Trident Large Diameter Hip System, Howmedica Osteonics Corp. (2006) Summary page 2.
- K010757: Lfit V40 Femoral Head Components, Howmedica Osteonics Corp. (2001) Summary page 2.
- K070885: Universal Taper Delta Femoral Head, Howmedica Osteonics Corp. (2007) Summary page 2.

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (2016), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Recalls of this device
- Jul 1, 2016 · Class II · Z-2396-2016: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.

## Indications for use
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only. The Exeter® Hip is indicated for: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * rheumatoid arthritis; * correction of functional deformity; * revision procedures where other treatments or devices have failed; and * treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K110290
Methodology: https://510kreport.com/methodology