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 Oct 3, 2022 as substantially equivalent to K122773 (Stelkast Company, 2012) and 4 other predicates after a 298-day review. Its family tree reaches back 9 generations to 1981. 1 later device descends from it.
- Decided
- Oct 3, 2022
- Review
- 298 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K810258 (1981). 53 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- 1 generation backK132158 Novohip Total Hip SystemNovosource, Inc. · 2014 · Recalled
- This deviceK213842 ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- 1 generation backK132158 Novohip Total Hip SystemNovosource, Inc. · 2014 · Recalled
- This deviceK213842 ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2009 | — |
| −1 | K132158 | Novohip Total Hip System | Novosource, Inc. | 2014 | 1 |
| 0 (this device) | K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022 | — |
| +1 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 24.3 · 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? (5)
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 |
|---|---|---|---|
| * | K122773 | Cross-Over Acetabular Shell & LinerSummary page 4…Product Codes: LPH, MBL, OQG Regulatory Class: II, Panel Code: 87 Primary Predicate: StelKast Cross-Over Acetabular Shell and Liner (K122773) Additional Predicates: Smith & Nephew REFLECTION 3 Shell (K070756) StelKast ProForm Hip System (K… | 2012 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 4…lass: II, Panel Code: 87 Primary Predicate: StelKast Cross-Over Acetabular Shell and Liner (K122773) Additional Predicates: Smith & Nephew REFLECTION 3 Shell (K070756) StelKast ProForm Hip System (K950827) NovoSource NovoHip Total Hip System (K132158)… | 2007 |
| * | K950827 | Proform Porous Acetabular AssemblySummary page 4…-Over Acetabular Shell and Liner (K122773) Additional Predicates: Smith & Nephew REFLECTION 3 Shell (K070756) StelKast ProForm Hip System (K950827) NovoSource NovoHip Total Hip System (K132158) Zimmer Trilogy Acetabular System (K93476… | 1995 |
| * | K132158 | Novohip Total Hip SystemSummary page 4…Smith & Nephew REFLECTION 3 Shell (K070756) StelKast ProForm Hip System (K950827) NovoSource NovoHip Total Hip System (K132158) Zimmer Trilogy Acetabular System (K934765) Purpose: The purpose of this submission is to request clearance… | 2014 |
| * | K934765 | Trilogy Acetabular SystemSummary page 4…StelKast ProForm Hip System (K950827) NovoSource NovoHip Total Hip System (K132158) Zimmer Trilogy Acetabular System (K934765) Purpose: The purpose of this submission is to request clearance for new acetabular shells, liners and bone screws. Device Des… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243456 | ONVOY™ Acetabular System | 2025 | 0 |
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 41 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 53 ancestors have a recall of any class.
- Of its descendants, K243456 (Globus Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122773.
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. 2022, 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…
Read the full statement (103 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.
The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213842 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213842: ONVOY Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213842
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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