# K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 13, 2020 after 247 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: 10 generations back to K921308 (1994). 127 ancestors in all.
6 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)
- K111848: Exeter X3 Rimfit Acetabular Cup, Stryker Corp. (2011) Summary page 5.
- K011623: Exeter Hip System with V40 Taper, Howmedica Osteonics Corp. (2001) Summary page 5.
- K052718: V40 Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005) Summary page 5.
- K110290: Exeter Hip Stem, Howmedica Osteonics Corp. (2011) Summary page 5.
- K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 5.
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 5.
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads, Stryker Orthopaedics (2018) Summary page 5.

## Most influential descendants
- K213701: Exeter® X3® RimFit® Cup (2022), 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
- 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

## Recalls of this device
- Aug 28, 2025 · Class II · Z-2640-2025: a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

## 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. The indications for use for total and hemi hip arthroplasty include: * 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. The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

Source page: https://510kreport.com/device/K193429
Methodology: https://510kreport.com/methodology