# K191414: EXETER Centralizer, EXETER 2.5mm Plug

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Aug 28, 2019 after 92 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921308 (1994). 131 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 4.
- K011623: Exeter Hip System with V40 Taper, Howmedica Osteonics Corp. (2001) Summary page 4.
- K980843: Exeter Intramedullary Bone Plug, Howmedica, Inc. (1998) Summary page 4.
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads, Stryker Orthopaedics (2018) Summary page 4.

## Most influential descendants
- 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
- K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (2026), 0 descendants of its own
- K250989: Stryker and Serf hip devices (2025), 0 descendants of its own
- K240418: Stryker Orthopaedics Hip Systems Labeling Update (2024), 0 descendants of its own

## Indications for use
1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement. The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

Source page: https://510kreport.com/device/K191414
Methodology: https://510kreport.com/methodology