510(k) · Cleared
Recalled · Class II · 2013Cross-Over Acetabular Shell & Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast Company · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Oct 9, 2012 as substantially equivalent to K001745 (Stelkast Company, 2000) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1981. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- OQG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K810258 (1981). 10 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 3 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 2 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 1 generation backK094035 Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded…Stelkast Company · 2011
- This deviceK122773 Cross-Over Acetabular Shell & LinerStelkast Company · 2012
- Descendant · cites it directly · 2 of its ownK190276 Provident II Hip StemStelkast, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK213842 ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK254043 TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK201733 Provident II Hip StemsGlobus Medical, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190276Provident II Hip StemStelkast, Inc. · 2019 · cites it directly2descendants
- K213842ONVOY Acetabular SystemGlobus Medical, Inc. · 2022 · cites it directly1descendant
- K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026 · 2 generations on0descendants
- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · 2 generations on0descendants
- K201733Provident II Hip StemsGlobus Medical, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −3 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −2 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −1 | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM | Stelkast Company | 2011 | — |
| 0 (this device) | K122773 | Cross-Over Acetabular Shell & Liner | Stelkast Company | 2012 | — |
| +1 | K190276 | Provident II Hip Stem | Stelkast, Inc. | 2019 | — |
| +1 | K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022 | — |
| +2 | K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026 | — |
| +2 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
| +2 | K201733 | Provident II Hip Stems | Globus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 OQG? 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 OQG device
- #1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K001745 | Modification to Provident Hip System | 2000 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 2…er Acetabular Shell and Liner to the following predicate devices: * Acetabular Shells in the Stelkast Provident Hip System (KOO 1745), and * EXp Acetabular Liner (K094035) These acetabular shells and liners have the same intended use and general design, are available in a similar size range, and ar… | 2011 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2013 | Class II | Z-1066-2013 | Device Design | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K190276 (Stelkast, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K001745.
How does its category compare?
All OQG devicesOQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OQG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OQG
99in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQG
16in 2025
MAUDE reports naming product code OQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 144 | 0 | 0 |
| 2013 | 3 | 280 | 1 | 5 |
| 2014 | 3 | 99 | 0 | 31 |
| 2015 | 1 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 3 | 99 | 0 | 27 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 104 |
| 2020 | 2 | — | 0 | 178 |
| 2021 | 2 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cross-Over Acetabular Shell and Liner are 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 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 (105 words)
The Cross-Over Acetabular Shell and Liner are 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 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 Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122773: Cross-Over Acetabular Shell & Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122773
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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