510(k) · Cleared
Recalled · Class II · 2023Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA
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 Mar 14, 2012 as substantially equivalent to K932246 (Encore Orthopedics, Inc., 1994) and 3 other predicates after an 84-day review. Its family tree reaches back 7 generations to 1981. 35 later devices descend from it. It has been recalled once.
- Decided
- Mar 14, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- OIY
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K810258 (1981). 41 ancestors in all. 35 later devices descend from it, 2 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 deviceK113756 Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 2012
- Descendant · cites it directly · 33 of its ownK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 2 generations on · 30 of its ownK131467 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 2 generations on · 30 of its ownK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 3 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
- Descendant · 3 generations on · 25 of its ownK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · cites it directly33descendants
- K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on30descendants
- K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on30descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on26descendants
- K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on25descendants
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) | K113756 | Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg… | Encore Medical L.P. | 2012 | — |
| +1 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +2 | K131467 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +2 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +3 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
| +3 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K932246 | Foundation Metal-Backed PatellaSummary page 1…ated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications. Predicate Devices: DJO Surgical Metal Backed Patella - K932246 OJO Surgical Tni-Peg Patella - K905613 DJO Surgical Movation Patella - K100900 DJO Surgical 3DKnee Insert - K09 1956 Comparable… | 1994 |
| * | K905613 | MTS Knee SystemSummary page 1…d surgical attempts. This system is to be used for cemented applications. Predicate Devices: DJO Surgical Metal Backed Patella - K932246 OJO Surgical Tni-Peg Patella - K905613 DJO Surgical Movation Patella - K100900 DJO Surgical 3DKnee Insert - K09 1956 Comparable Features to Predicate Device(s): Featur… | 1991 |
| * | K100900 | Motivation Knee SystemSummary page 1…e used for cemented applications. Predicate Devices: DJO Surgical Metal Backed Patella - K932246 OJO Surgical Tni-Peg Patella - K905613 DJO Surgical Movation Patella - K100900 DJO Surgical 3DKnee Insert - K09 1956 Comparable Features to Predicate Device(s): Features comparable to predicate devices inclu… | 2010 |
| * | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Summary page 1…edicate Devices: DJO Surgical Metal Backed Patella - K932246 OJO Surgical Tni-Peg Patella - K905613 DJO Surgical Movation Patella - K100900 DJO Surgical 3DKnee Insert - K09 1956 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials… | 2010 |
What descends from it? (35)
See all 352 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 |
|---|---|---|---|---|
| Oct 5, 2023 | Class II | Z-0626-2024 | Packaging process control | Mislabeling |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 41 ancestors have a recall of any class.
- Of its descendants, K122870 (Conformis, Inc., 2013) has gone furthest, with 33 descendants of its own.
- 1 other device also cites its predicate K932246.
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. 2012, 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 patellofemoral erosion, dysfunction or prior patellectomy;
* moderate valgus, varus or flexion deformities;
* treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113756
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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