510(k) · Cleared
ClearedVitalite E Cross-Linked Polyethylene Acetabular Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consensus Orthopedics, Inc. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Dec 17, 2013 as substantially equivalent to K100933 (Consensus Orthopedics, Inc., 2010) and 5 other predicates after a 280-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Dec 17, 2013
- Review
- 280 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K931641 (1994). 84 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 4 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 3 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 2 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 1 generation backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- This deviceK130652 Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −4 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −3 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −2 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| 0 (this device) | K130652 | Vitalite E Cross-Linked Polyethylene Acetabular Insert | Consensus Orthopedics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (6)
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 |
|---|---|---|---|
| * | K100933 | Consensus CS2 Plus Acetabular InsertSummary page 2…abular Cup System is identical iii design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 5 10(k)'s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus C52 insert is identical to the poly cleared for the StelKast EXp acetabular liner i… | 2010 |
| * | K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertSummary page 2…the CS2 Acetabular Cup System is identical iii design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 5 10(k)'s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus C52 insert is identical to the poly cleared for the StelKast EXp aceta… | 2007 |
| * | K021466 | Consensus Acetabular Insert, Cross-Linked PolyethyleneSummary page 2…nsert for the CS2 Acetabular Cup System is identical iii design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 5 10(k)'s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus C52 insert is identical to the poly cleared for the StelKast… | 2002 |
| * | K122773 | Cross-Over Acetabular Shell & LinerSummary page 2…1466, K070061, and K100933. The vitamin E poly used in the new Consensus C52 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level). Based on the material, characterization data, geometry and mechanical testing… | 2012 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 2…10(k)'s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus C52 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level). Based on the material, characterization data, geometry and mechan… | 2011 |
| * | K112802 | Pipeline Total Hip SystemSummary page 2…nked Polyethylene Acetabular Insert K(122773 (SteKast, Inc.): Cross-Over Acetabular Shell and Liner (lateralized) K(094035 (StelKast, Inc.): EXp Acetabular Shell Liner 1(112802 (Pipeline Orthopedics, Inc.): Pipeline Total Hip System Non-Clinical Performance Data: Non-clinical testing and analysis were pr… | 2012 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 84 ancestors have a recall of any class.
- 4 other devices also cite its predicate K100933.
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. 2013, 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 Consensus CS2TM Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, C52 Hip System, or UJNISYNTM Hip System for the following indications: A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E)…
Read the full statement (141 words)
The Consensus CS2TM Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, C52 Hip System, or UJNISYNTM Hip System for the following indications:
A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.
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/K130652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130652: Vitalite E Cross-Linked Polyethylene Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130652
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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