# K233498: Stryker Orthopaedics Hip Systems Labeling Update

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Dec 21, 2023 after 51 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: 20 generations back to K941847 (1994). 318 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 14.
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads, Stryker Orthopaedics (2018) Summary page 14.
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem, Stryker (2022) Summary page 14.
- K212187: Restoration® Modular Hip System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2022) Summary page 14.
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2019) Summary page 14.
- K191358: Trident II Acetabular System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2019) Summary page 15.
- K210893: Restoration Anatomic Shell, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2021) Summary page 15.
- K222632: UHR Bipolar Implants, Restoration GAP II Implants, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2022) Summary page 15.
- K213701: Exeter® X3® RimFit® Cup, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2022) Summary page 15.
- K220376: Acetabular Dome Hole Plug, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2022) Summary page 15.
- K220838: Artisan Bone Plug, Universal Cement Restrictor, Howmedica Osteonics, Dba Stryker Orthopaedics (2022) Summary page 16.
- K202016: Dall-Miles® Cable System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2020) Summary page 16.
- K191414: EXETER Centralizer, EXETER 2.5mm Plug, Stryker Orthopaedics (2019) Summary page 16.

## Most influential descendants
- 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
ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners 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 MDM Liners are intended for cementless use only. Universal Cement Restrictor, OmniFit Distal Cement Spacer For cement spacers, mid-shaft restrictors and Cement Plugs: » In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous. Artisan Bone Plug These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal. Trident® II Acetabular System (Trident II Cups (Clusterhole HA, PLS Clusterhold HA, Tritanium Clusterhole, Tritanium Multihole, Tritanium Solidback), 6.5mm Low Profile Hex Screw, Hex Dome Hole Plug) » 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM Liners * Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. * Dislocation risks When used with Constrained Liner: * The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Trident® II Acetabular Shells are indicated for cementless use only. Restoration® Modular Hip System The Restoration® Modular Hip System is indicated for use in: * Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; * Rheumatoid arthritis * Correction of functional deformity; * Revisions procedure 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 indications specific to the Restoration Modular Hip System The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Accolade II Femoral Stems, Anato Femoral Stem, Secur-Fit Advanced 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 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. The Stems are intended for cementless use only and are intended for total and hemiarthroplasty. TRIDENT AND TRITANIUM® ACETABULAR COMPONENTS » 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. The HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only. Dome hole plug is indicated for cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous Acetabular Dome Hole Plug The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the acetabular cup. The Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell. Indications * In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous. DALL-MILES® SYSTEMS The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach. The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only. The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation. The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device. The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies. Exeter® V40™ Hip System (includes Orthinox V40 Femoral heads) The Exeter® V40™ Femoral Hip System is indicated for: » 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 Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only. Exeter Centralizer, EXETER Intramedullary Plug 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. The Exeter Centralizer is intended to be used with bone cement. The Exeter 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. The Exeter Intramedullary Bone Plug is intended to be used with bone cement. Exeter X3 RimFit Cups The indications for use for total hip arthroplasty include: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. 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. Restoration GAP II Acetabular Shell 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 as indicated by deficiencies of the acetabulum. Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures. Gap Screws, Torx Screws, and Osteolock Bone Screws HOWMEDICA OSTEONICS Torx Cancellous Bone Screws are intended for supplemental fixation of associated HOWMEDICA OSTEONICS cementless Acetabular Shells. * HOWMEDICA OSTEONICS RESTORATION GAP Plate Screws are intended for fixation of the dome and iliac plates of the associated HOWMEDICA OSTEONICS RESTORATION GAP Acetabular Shell, TRIDENT TRITANIUM Hemispherical Multihole Acetabular Shells, restoration Acetabular Augments, and Restoration Anatomic shells. Insignia Hip Stem Hip Arthroplasty Indications: » Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. * Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure. » Correction of functional deformity * Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of Insignia 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. Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: » When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures. Omnifit HFX Femoral Stems For use as a Bipolar Hip Replacement: * Femoral head/neck fractures or non-unions. * Aseptic necrosis of the femoral head. * Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: » Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. » Salvage of failed total hip arthroplasty. * Femoral neck fractures. For use as a Total Hip Replacement: » 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. * Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis. Omnifit EON Cemented Femoral Stems For use as a Bipolar Hip Replacement: * Femoral head/neck fractures or non-unions. * Aseptic necrosis of the femoral head. * Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: » Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. » Salvage of failed total hip arthroplasty. For use as a Total Hip Replacement: » 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. Indications for use as a Total Hip Replacement 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. Restoration Anatomic Shell » 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. When used with MDM Liners * Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. * Dislocation risks When used with Constrained Liner: * The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Restoration® Anatomic Shell is indicated for cementless use only. Trident Constrained Acetabular Insert/ Constrained Acetabular Insert The Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Trident X3, Trident Crossfire, and Trident X3/Crossfire Elevated Rim Acetabular Liners » 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. UHR Bipolar * Femoral head/neck fractures or non-unions. * Aseptic necrosis of the femoral head. * Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: » Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. » Salvage of failed total hip arthroplasty. Unitrax V40 Head, V40 Adapter Sleeve and C-Taper Adapter Sleeve The HOWMEDICA OSTEONICS Unitrax Endoprosthesis, and the V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and non-unions. The C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or non-unions, aseptic necrosis of the femoral head/neck and osteo- and post traumatic arthritis. The patient’s acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis. BIOLOX Delta Ceramic Heads (V40, C-Taper and Universal and C-Taper to Universal Taper Adapter Sleeve) The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. For Use as a Total Hip Replacement: » Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. * Revision of previous cup arthroplasty or other procedures * 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 in the acetabulum. For Use as a Bipolar Hip Replacement * Femoral head/neck fractures or non-unions. * Aseptic necrosis of the femoral head. * Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. » Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. » Salvage of failed total hip arthroplasty Alumina C-Taper and V40 Ceramic Heads For Use as a Total Hip Replacement: » Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. * Revision of previous cup arthroplasty or other procedures * 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 in the acetabulum. Additional indications for the Alumina C-Taper Ceramic Heads For Use as a Bipolar Hip Replacement * Femoral head/neck fractures or non-unions. * Aseptic necrosis of the femoral head. * Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. » Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. » Salvage of failed total hip arthroplasty Co Cr Femoral Heads (C-Taper and V40 Taper, LFIT and non-LFIT) » Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. * Revision of previous cup arthroplasty or other procedures * 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 in the acetabulum. Accolade C Femoral Stems, Accolade HFx Femoral Stems Indications for use as a Total Hip Replacement 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. Accolade TMZF and Accolade TMZF Plus Femoral Stems The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40’ trunnion. Indications: » Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. * Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. » Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K233498
Methodology: https://510kreport.com/methodology