510(k) · Cleared
ClearedX-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded, 20 Degree Hooded
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 Nov 6, 2014 as substantially equivalent to K973119 (Encore Orthopedics, Inc., 1998) and 3 other predicates after a 293-day review. Its family tree reaches back 8 generations to 1981. 1 later device descends from it.
- Decided
- Nov 6, 2014
- Review
- 293 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K810258 (1981). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 2 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 1 generation backK130365 X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013
- This deviceK140130 X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral…Encore Medical L.P. · 2014
- Descendant · cites it directly · 0 of its ownK191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral…Signature Orthopaedics Pty, Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −4 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −3 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −1 | K130365 | X-Alt Highly Cross Linked VE Acetabular Liner | Encore Medical L.P. | 2013 | — |
| 0 (this device) | K140130 | X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree… | Encore Medical L.P. | 2014 | — |
| +1 | K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty, Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K973119 | Foundation Porous Acetabular SystemSummary page 4…cture. This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only Predicate Device: K973119, K974093, K974095 – DJO Surgical FMP Acetabular Shells with Standard Poly Liner (Spiked, Hemispherical, Flared Shells) K13… | 1998 |
| * | K974093 | Foundation Porous Coated Hemispherical ShellSummary page 4…This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only Predicate Device: K973119, K974093, K974095 – DJO Surgical FMP Acetabular Shells with Standard Poly Liner (Spiked, Hemispherical, Flared Shells) K130365 – DJ… | 1998 |
| * | K974095 | Foundation Porous Coated Flared Rim ShellSummary page 4…ce may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only Predicate Device: K973119, K974093, K974095 – DJO Surgical FMP Acetabular Shells with Standard Poly Liner (Spiked, Hemispherical, Flared Shells) K130365 – DJO Surgica… | 1998 |
| * | K130365 | X-Alt Highly Cross Linked VE Acetabular LinerSummary page 4…ess use only Predicate Device: K973119, K974093, K974095 – DJO Surgical FMP Acetabular Shells with Standard Poly Liner (Spiked, Hemispherical, Flared Shells) K130365 – DJO Surgical X-alt Highly Cross Linked Acetabular Liners with Vitamin E Comparable Features to Predicate Device(s): Features… | 2013 |
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 |
|---|---|---|---|
| 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 33 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 31 ancestors have a recall of any class.
- Of its descendants, K191708 (Signature Orthopaedics Pty, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K973119.
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. 2014, 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/K140130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140130: X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded, 20 Degree Hooded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140130
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