# K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Mar 19, 2018 after 126 days
- Product code: JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921308 (1994). 125 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 134 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 4.
- K110290: Exeter Hip Stem, Howmedica Osteonics Corp. (2011) Summary page 4.
- K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 4.
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 4.
- K051741: Accolade HFX Femoral Stem, Stryker Orthopaedics (2005) Summary page 4.
- K130610: Sirius Femoral Stem, Biomet, Inc. (2013) Summary page 5.
- K142295: Sirius Femoral Stem, Size 30A, Biomet, Inc. (2014) Summary page 5.

## Most influential descendants
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own
- K213701: Exeter® X3® RimFit® Cup (2022), 5 descendants of its own
- K191414: EXETER Centralizer, EXETER 2.5mm Plug (2019), 5 descendants of its own
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own

## Recalls of this device
- Oct 15, 2021 · Class II · Z-0313-2022: XXX
- Oct 15, 2021 · Class II · Z-0314-2022: There is a potential for the outer white Tyvek lid to debond from the sealed package.

## Indications for use
The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only. The Exeter® V40™ Femoral Stem Hip System is indicated for: » noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; » theumatoid 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/K173499
Methodology: https://510kreport.com/methodology