510(k) · Cleared
ClearedX-Alt Highly Cross Linked VE Acetabular Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Sep 23, 2013 as substantially equivalent to K072154 (Encore Medical L.P., 2007) and 1 other predicate after a 222-day review. Its family tree reaches back 7 generations to 1981. 38 later devices descend from it.
- Decided
- Sep 23, 2013
- Review
- 222 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K810258 (1981). 30 ancestors in all. 38 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 4 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 3 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 2 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 1 generation backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- This deviceK130365 X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013
- Descendant · cites it directly · 21 of its ownK141006 RSP Humeral Socket InsertDjo Global · 2014 · Recalled
- Descendant · 2 generations on · 18 of its ownK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- Descendant · 3 generations on · 15 of its ownK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- Descendant · cites it directly · 7 of its ownK140830 Exprt Revision KneeEncore Medical L.P. · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K141006RSP Humeral Socket InsertDjo Global · 2014 · cites it directly21descendants
- K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P. · 2017 · 2 generations on18descendants
- K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019 · 3 generations on15descendants
- K140830Exprt Revision KneeEncore Medical L.P. · 2014 · cites it directly7descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −6 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −5 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −4 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −3 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −2 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −1 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| 0 (this device) | K130365 | X-Alt Highly Cross Linked VE Acetabular Liner | Encore Medical L.P. | 2013 | — |
| +1 | K141006 | RSP Humeral Socket Insert | Djo Global | 2014 | 2 |
| +2 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| +3 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| +1 | K140830 | Exprt Revision Knee | Encore Medical L.P. | 2014 | 1 |
| +3 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K072154 | Foundation (FMP) Porous Coated Spiked Acetabular SystemSummary page 1…th pure liquid phannaceutical grade aipha-tocopheral. The liners are the same dimensions and size offerings as the currently cleared Highly Cross Linked Poly liners (K072 154) (28mmu, 32mm. 34mm, 36mm, 40mm, and 44mmn ID. with neutral, 10.' and 20' hooded configurations available in each ID). Indic… | 2007 |
| * | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Summary page 1…2301 * DJO Surgical X-altTM H-ighly Cross Linked Acetabular Liner - K072154 * DJO Surgical 3DKnee Tibial Insert with Vitamnin E - K091956 Comparable Features to Predicate Device(s): Features comparable to predicate devices inIclude the same design featUres, mate… | 2010 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141006 | RSP Humeral Socket Insert | 2014 | 21 |
| K140830 | Exprt Revision Knee | 2014 | 7 |
| K172651 | FMP Extended Liners | 2017 | 3 |
| K190057 | DJO Acetabular System | 2019 | 2 |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | 2018 | 2 |
| K140130 | X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded… | 2014 | 1 |
| K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | 2020 | 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 32 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 30 ancestors have a recall of any class.
- Of its descendants, K141006 (Djo Global, 2014) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K072154.
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?
Joint replacement is indicated for patients suffering from disability due to
noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
rheumatoid arthritis;
correction of functional deformity;
femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is intended for cementless use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130365: X-Alt Highly Cross Linked VE Acetabular Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130365
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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