# K213701: Exeter® X3® RimFit® Cup

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Feb 1, 2022 after 69 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: 11 generations back to K921308 (1994). 128 ancestors in all.
5 later devices descend from it; 2 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)
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup, Howmedica Osteonics Corp. (2020) Summary page 4.
- K111848: Exeter X3 Rimfit Acetabular Cup, Stryker Corp. (2011) 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
The indications for use for total hip arthroplasty include: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late-stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only.

Source page: https://510kreport.com/device/K213701
Methodology: https://510kreport.com/methodology