# K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Mar 19, 2019 after 190 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921308 (1994). 119 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033716: Trident Acetabular System, Howmedica Osteonics Corp. (2005) Summary page 6.
- K061434: Trident Large Diameter Hip System, Howmedica Osteonics Corp. (2006) Summary page 6.
- K062419: Trident Large Diameter Acetabular Inserts, Howmedica Osteonics Corp. (2006) Summary page 6.
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 6.
- K093644: Restoration Adm System X3 Acetabular, Howmedica Osteonics Corp. (2009) Summary page 6.
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 6.
- K112556: Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts, Howmedica Osteonics Corp. (2011) Summary page 6.
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 6.
- K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 6.

## 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
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own

## Indications for use
Trident Acetabular Component System Indications for Use: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Restoration ADM Acetabular Cup and MDM Liner Systems The indications for use for total hip arthroplasty include: 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. 6. Dislocation risks RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only. Accolade II Hip System The indications for use of the total hip replacement prostheses include: 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. Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners: 1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Source page: https://510kreport.com/device/K182468
Methodology: https://510kreport.com/methodology