510(k) · Cleared
ClearedONVOY™ Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 6, 2025 as substantially equivalent to K213842 (Globus Medical, Inc., 2022) and 8 other predicates after a 211-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- Jun 6, 2025
- Review
- 211 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 12 generations to K810258 (1981). 286 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- 1 generation backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- This deviceK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 4 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 3 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- 1 generation backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- This deviceK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −5 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −4 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| −3 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| −2 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| −1 | K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 | — |
| 0 (this device) | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 6 | 0 |
| 1993 | 2 | 0 |
| 1994 | 24 | 0 |
| 1995 | 18 | 0 |
| 1996 | 15 | 0 |
| 1997 | 11 | 0 |
| 1998 | 12 | 0 |
| 1999 | 11 | 0 |
| 2000 | 24 | 0 |
| 2001 | 12 | 0 |
| 2002 | 18 | 0 |
| 2003 | 11 | 0 |
| 2004 | 8 | 0 |
| 2005 | 13 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 4 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213842 | ONVOY Acetabular SystemSummary page 5…s Product Codes: LPH, MBL, OQG, LZO Regulatory Class: II, Panel Code: 87 Primary Predicate: ONVOY™ Acetabular System (K213842) Additional Predicates: Smith and Nephew OR3O (K191002) Zimmer Biomet G7® Dual Mobility System… | 2022 |
| * | K191002 | OR3O Dual Mobility SystemSummary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: ONVOY™ Acetabular System (K213842) Additional Predicates: Smith and Nephew OR3O (K191002) Zimmer Biomet G7® Dual Mobility System (K150522, K161190)… | 2019 |
| * | K150522 | G7 Dual Mobility SystemSummary page 5…ONVOY™ Acetabular System (K213842) Additional Predicates: Smith and Nephew OR3O (K191002) Zimmer Biomet G7® Dual Mobility System (K150522, K161190) Zimmer Biomet G7® Acetabular System (K190660)… | 2015 |
| * | K161190 | G7 Dual Mobility System, Active Articulation SystemSummary page 5…42) Additional Predicates: Smith and Nephew OR3O (K191002) Zimmer Biomet G7® Dual Mobility System (K150522, K161190) Zimmer Biomet G7® Acetabular System (K190660) StelKast EXp Acetabular Li… | 2016 |
| * | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Summary page 5…Zimmer Biomet G7® Dual Mobility System (K150522, K161190) Zimmer Biomet G7® Acetabular System (K190660) StelKast EXp Acetabular Liner (K094035) Stryker Trident X3 (K182468)… | 2019 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 5…K161190) Zimmer Biomet G7® Acetabular System (K190660) StelKast EXp Acetabular Liner (K094035) Stryker Trident X3 (K182468) Stryker MDM X3 (K103233)… | 2011 |
| * | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemSummary page 5…Zimmer Biomet G7® Acetabular System (K190660) StelKast EXp Acetabular Liner (K094035) Stryker Trident X3 (K182468) Stryker MDM X3 (K103233) Signature SignaSure Dual Mobility System (K2204… | 2019 |
| * | K103233 | Modular Dual Mobility Liner, X3 Acetabular InsertSummary page 5…StelKast EXp Acetabular Liner (K094035) Stryker Trident X3 (K182468) Stryker MDM X3 (K103233) Signature SignaSure Dual Mobility System (K220495) Reference Devices: HEDRON® Cervical & L… | 2011 |
| * | K220495 | SignaSure Dual Mobility SystemSummary page 5…Stryker Trident X3 (K182468) Stryker MDM X3 (K103233) Signature SignaSure Dual Mobility System (K220495) Reference Devices: HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable Spacer (K222270)… | 2023 |
| † | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 44 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 83 of the 286 ancestors have a recall of any class.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
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…
Read the full statement (106 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243456: ONVOY™ Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243456
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026