# K243456: ONVOY™ Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 6, 2025 after 211 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: 12 generations back to K810258 (1981). 286 ancestors in all.
No later device cites it as a predicate yet.
0 of 287 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213842: ONVOY Acetabular System, Globus Medical, Inc. (2022) Summary page 5.
- K191002: OR3O Dual Mobility System, Smith & Nephew, Inc. (2019) Summary page 5.
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 5.
- K161190: G7 Dual Mobility System, Active Articulation System, Biomet, Inc. (2016) Summary page 5.
- K190660: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene, Zimmer, Inc. (2019) Summary page 5.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 5.
- 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 5.
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 5.
- K220495: SignaSure Dual Mobility System, Signature Orthopaedics Pty, Ltd. (2023) Summary page 5.

## Indications for use
The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. 6. Dislocation risks. The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

Source page: https://510kreport.com/device/K243456
Methodology: https://510kreport.com/methodology