# K213842: ONVOY Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Oct 3, 2022 after 298 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 K810258 (1981). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122773: Cross-Over Acetabular Shell & Liner, Stelkast Company (2012) Summary page 4.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 4.
- K950827: Proform Porous Acetabular Assembly, Stelkast Company (1995) Summary page 4.
- K132158: Novohip Total Hip System, Novosource, Inc. (2014) Summary page 4.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 4.

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

## 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. The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.

Source page: https://510kreport.com/device/K213842
Methodology: https://510kreport.com/methodology