# 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

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Jul 10, 2026 after 56 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: 22 generations back to K941847 (1994). 328 ancestors in all.
No later device cites it as a predicate yet.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243784: Stryker Orthopaedics Hip Devices Labeling Update, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025) Summary page 7.
- K900438: MC2P Acetabular Component, Osteonics Corp. (1990) Summary page 7.
- K974685: Osteonics Polyethylene Acetabular Components, Osteonics Corp. (1998) Summary page 7.
- K890197: Omnifit Constrained Acetabular Bearing Insert, Osteonics Corp. (1989) Summary page 7.
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 7.
- K983502: Osteonics Secur-Fit AD Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 7.
- K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts, Howmedica Osteonics Corp. (1999) Summary page 7.
- K021911: Trident Crossfire Polyuethylene Liners, Howmedica Osteonics Corp. (2002) Summary page 7.
- K233498: Stryker Orthopaedics Hip Systems Labeling Update, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 7.
- K993352: Crossfire System 12 Acetabular Inserts, Howmedica Osteonics Corp. (1999) Summary page 8.
- K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 8.
- K061654: Trident Constrained Acetabular Insert, Howmedica Osteonics Corp. (2006) Summary page 8.
- K951860: Howmedice Bone Plug, Howmedica Corp. (1995) Summary page 8.
- K220838: Artisan Bone Plug, Universal Cement Restrictor, Howmedica Osteonics, Dba Stryker Orthopaedics (2022) Summary page 8.
- K800207: Uhr UNIVERSAL6HIP Replacement, Osteonics Corp. (1980) Summary page 8.
- K910988: Osteonics Ion Implanted Femoral Bearing Series, Osteonics Corp. (1991) Summary page 8.
- K993601: Howmedica Osteonics Femoral Heads, Howmedica Osteonics Corp. (1999) Summary page 8.
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads, Stryker Orthopaedics (2018) Summary page 8.
- K222632: UHR Bipolar Implants, Restoration GAP II Implants, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2022) Summary page 8.

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3201-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m
- Jul 30, 2026 · Class II · Z-3199-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m

## Indications for use
Omnifit® 20 ° Series I Insert, Omnifit® Crossfire® 10 ° Series II Insert, Omnifit® Crossfire® 10 ° Eccentric Insert, Trident® Crossfire 0 ° and 10 ° Polyethylene Insert • 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Constrained Acetabular Insert, Trident® 0 ° Constrained Acetabular Insert, Trident® Constrained Acet. Liner, Trident® All Poly Constrained Acetabular Insert A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis 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. System 12 Crossfire® 10 ° Insert • 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 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. UHR® Universal Head Bipolar Component • 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. • Salvaae of failed total hio arthroolastv.

Source page: https://510kreport.com/device/K261624
Methodology: https://510kreport.com/methodology