510(k) · Cleared
Recalled · Class II · 2017Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Cleared on Sep 28, 2010 as substantially equivalent to K020114 (Encore Orthopedics, Inc., 2002) and 1 other predicate after a 454-day review. Its family tree reaches back 6 generations to 1981. 119 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 28, 2010
- Review
- 454 days
- Class
- Class II
- Product code
- OIY
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 6 generations to K810258 (1981). 24 ancestors in all. 119 later devices descend from it, 9 citing it directly.
- Root · 6 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 4 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 3 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 2 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 1 generation backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- This deviceK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010
- Descendant · cites it directly · 38 of its ownK130365 X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013
- Descendant · cites it directly · 37 of its ownK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- Descendant · cites it directly · 35 of its ownK123982 Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P. · 2013
- Descendant · cites it directly · 35 of its ownK113756 Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 2012 · Recalled
- Descendant · 2 generations on · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013 · cites it directly38descendants
- K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010 · cites it directly37descendants
- K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P. · 2013 · cites it directly35descendants
- K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P. · 2012 · cites it directly35descendants
- K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −5 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −4 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −3 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −2 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −1 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| 0 (this device) | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | — |
| +1 | K130365 | X-Alt Highly Cross Linked VE Acetabular Liner | Encore Medical L.P. | 2013 | — |
| +1 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| +1 | K123982 | Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+ | Encore Medical L.P. | 2013 | — |
| +1 | K113756 | Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg… | Encore Medical L.P. | 2012 | 1 |
| +2 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
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 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 11 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 3 | 0 |
| 2025 | 11 | 0 |
| 2026 | 7 | 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 OIY? 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 OIY device
- #1 K252887 DePuy ATTUNE™ Knee Systemscore 12.6 · 5 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 |
|---|---|---|---|
| * | K020114 | 3D KNEESummary page 1…osthesis (888.3560), OIY, JWH, MBH Legally Marketed Devices to Which Substantial Equivalence is Claimed: 3DKnee K0201 14 Encore Medical E-Poly Tibial Bearings K080528 Biomet Device Description: The Highly Cross-Linke… | 2002 |
| * | K080528 | E-Poly Tibial BearingsSummary page 1…egally Marketed Devices to Which Substantial Equivalence is Claimed: 3DKnee K0201 14 Encore Medical E-Poly Tibial Bearings K080528 Biomet Device Description: The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ul… | 2008 |
What descends from it? (119)
See all 1199 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130365 | X-Alt Highly Cross Linked VE Acetabular Liner | 2013 | 38 |
| K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | 2010 | 37 |
| K123982 | Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+ | 2013 | 35 |
| K113756 | Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly… | 2012 | 35 |
| K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2013 | 33 |
| K121727 | Movation Knee System | 2012 | 14 |
| K143242 | Rebel 3DKNEE System | 2015 | 11 |
| K112897 | Renovis Surgical Hip Joint Replacement Prosthesis | 2012 | 8 |
| K131337 | Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella | 2013 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2017 | Class II | Z-2659-2017 | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. |
| May 31, 2017 | Class II | Z-2658-2017 | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. |
| Apr 1, 2013 | Class II | Z-1213-2013 | Labeling mix-ups | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency.… |
| Aug 9, 2012 | Class II | Z-2302-2012 | Incorrect or no expiration date | The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K130365 (Encore Medical L.P., 2013) has gone furthest, with 38 descendants of its own.
- 6 other devices also cite its predicate K020114.
How does its category compare?
All OIY devicesOIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OIY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OIY
132in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OIY
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OIY
35in 2025
MAUDE reports naming product code OIY, 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 | 4 | 132 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 1 | 84 |
| 2015 | 0 | — | 1 | 282 |
| 2016 | 0 | — | 0 | 130 |
| 2017 | 0 | — | 0 | 91 |
| 2018 | 0 | — | 0 | 68 |
| 2019 | 0 | — | 0 | 78 |
| 2020 | 1 | — | 0 | 121 |
| 2021 | 0 | — | 0 | 379 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 40 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Joint replacement is indicated for patients suffering from disability due to:
* degenerative, post-traumatic or rheumatoid arthritis;
* avascular necrosis of the femoral condyle;
* post-traumatic loss of joint configuration, particularly when there is ipatellofemoral erosion, dysfunction or prior patellectomny;
* moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is intended to be used with the 3DKnee System for cemented or uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091956
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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