510(k) · Cleared
ClearedMovation Knee System
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 Aug 15, 2012 as substantially equivalent to K100900 (Encore Medical L.P., 2010) and 1 other predicate after a 64-day review. Its family tree reaches back 7 generations to 1981. 14 later devices descend from it.
- Decided
- Aug 15, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- OIY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K810258 (1981). 40 ancestors in all. 14 later devices descend from it, 3 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 deviceK121727 Movation Knee SystemEncore Medical L.P. · 2012
- Descendant · cites it directly · 11 of its ownK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- Descendant · cites it directly · 7 of its ownK140830 Exprt Revision KneeEncore Medical L.P. · 2014 · Recalled
- Descendant · cites it directly · 6 of its ownK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK180930 Empowr VVC Tibial InsertEncore Medical L.P. · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK230169 EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K143242Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · cites it directly11descendants
- K140830Exprt Revision KneeEncore Medical L.P. · 2014 · cites it directly7descendants
- K160342EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · cites it directly6descendants
- K180930Empowr VVC Tibial InsertEncore Medical L.P. · 2018 · 2 generations on3descendants
- K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023 · 3 generations on2descendants
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) | K121727 | Movation Knee System | Encore Medical L.P. | 2012 | — |
| +1 | K143242 | Rebel 3DKNEE System | Encore Medical L.P. | 2015 | 17 |
| +1 | K140830 | Exprt Revision Knee | Encore Medical L.P. | 2014 | 1 |
| +1 | K160342 | EMPOWR PS Knee System | Encore Medical L.P. | 2016 | 5 |
| +2 | K180930 | Empowr VVC Tibial Insert | Encore Medical L.P. | 2018 | 1 |
| +3 | K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | 2023 | — |
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 | 7 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K100900 | Motivation Knee SystemSummary page 1…Y constrained cemented prosthesis per 21 CFR 888.3560 Legally Marketed Devices to which Substantial Equivalence is Claimed: Movation Knee K100900 DJO Surgical FIXL Vitamin E Tibial Insert K09 1956 DJO Surgical Description… | 2010 |
| * | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Summary page 1…eted Devices to which Substantial Equivalence is Claimed: Movation Knee K100900 DJO Surgical FIXL Vitamin E Tibial Insert K09 1956 DJO Surgical Description: The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured fr… | 2010 |
What descends from it? (14)
See all 143 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)
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 31 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 18 of the 40 ancestors have a recall of any class.
- Of its descendants, K143242 (Encore Medical L.P., 2015) has gone furthest, with 11 descendants of its own.
- 7 other devices also cite its predicate K100900.
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?
The Movation Knee System is 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, dystfunction 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/K121727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121727: Movation Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121727
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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