# K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Feb 9, 2015 after 105 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 7 generations back to K921308 (1994). 39 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 9.
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 9.
- K013676: Trident Hemispherical Acetabular Shells, Howmedica Osteonics Corp. (2001) Summary page 9.
- K081171: Tritanium Acetabular Shell System, Howmedica Osteonics Corp. (2008) Summary page 9.
- K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 9.
- K122853: Novel Fit and Fill Stem, Howmedica Osteonics Corp. (2013) Summary page 9.
- K123604: Abg Iii Monolithic Hip Stem, Howmedica Osteonics Corp. (2013) Summary page 9.

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K171768: Trident® II Acetabular System (2017), 10 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Recalls of this device
- Jul 21, 2017 · Class II · Z-0940-2018: Inner and outer sterile barriers not fully sealed.
- Jul 21, 2017 · Class II · Z-0941-2018: Inner and outer sterile barriers not fully sealed.

## 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. The Trident shells are intended for cementless fixation within the prepared acetabulum. 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. The Tritanium Acetabular Shell System is intended for cementless use only. The indications for use for total hip arthroplasty with stems 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, 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 the Accolade II Femoral Stem with compatible Howmedica Osteonics Constrained Liners: 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. The indications for use for total hip arthroplasty with stems 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, 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 Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners: 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. Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures. The indications for use for total hip arthroplasty with stems 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, 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 Anato Hip Stem with compatible Howmedica Osteonics Constrained Liners: 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. The Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

Source page: https://510kreport.com/device/K143085
Methodology: https://510kreport.com/methodology