510(k) Report

510(k) · Cleared

Cleared

Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VE

K121835510(k) SpecialCleared Jul 20, 201228-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encore Medical L.P. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 20, 2012 as substantially equivalent to K905613 (T & R Mfg., Inc., 1991) and 3 other predicates after a 28-day review. Its family tree reaches back 8 generations to 1981.

Decided
Jul 20, 2012
Review
28 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K810258 (1981). 42 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2002: 2 other ancestors1991: 1 other ancestor2003: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1995: 7 other ancestors1994: 8 other ancestors1993: 2 other ancestors1996: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor1992: 3 other ancestors1997: 1 other ancestorK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK050327 · E-Poly (Vitamin E) Acetabular Liners · Biomet, Inc. · 2005K070364 · 100KGY E-Poly Maxrom Acetabular Liners · Biomet, Inc. · 2007K080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008K091956 · Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 · Encore Medical L.P. · 2010 · recalledK113756 · Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA · Encore Medical L.P. · 2012 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 5 other ancestors4 generations back: 3 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor7 generations back: 7 other ancestors8 generations back: 2 other ancestors K113756 · Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA · Encore Medical L.P. · 2012 · recalledK091956 · Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 · Encore Medical L.P. · 2010 · recalledK080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008K070364 · 100KGY E-Poly Maxrom Acetabular Liners · Biomet, Inc. · 2007K050327 · E-Poly (Vitamin E) Acetabular Liners · Biomet, Inc. · 2005K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−50
  1. Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 2 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
  8. 1 generation backK113756 Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 2012 · Recalled
  9. This deviceK121835 Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella…Encore Medical L.P. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−7K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−6K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−5K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−4K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−3K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−2K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20104
−1K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg…Encore Medical L.P.20121
0 (this device)K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
199110
199230
199320
199480
199570
199610
199710
200010
200110
200220
200320
200410
200510
201010
FIG. 1 — Lineage of K121835, 1981–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JWH? 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 JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K905613MTS Knee System
Summary page 1
…in the salvage of previously failed surgical attempts. This system is to be used for cemented applications Predicate Devices: DJO Surgical Domed Tni-Peg Patella - K9056 13 DJO Surgical Movation Domed Patella - K100900 DJO Surgical 3DKnee Standard Poly Material - K0201 14 DJO Surgical e+ Patella HI…
T & R Mfg., Inc.1991—
*K100900Motivation Knee System
Summary page 1
…tempts. This system is to be used for cemented applications Predicate Devices: DJO Surgical Domed Tni-Peg Patella - K9056 13 DJO Surgical Movation Domed Patella - K100900 DJO Surgical 3DKnee Standard Poly Material - K0201 14 DJO Surgical e+ Patella HIXL VE Poly - K 113756 DJO Surgical 3DKnee Ster…
Encore Medical L.P.20104
*K0201143D KNEE
Summary page 1
…cations Predicate Devices: DJO Surgical Domed Tni-Peg Patella - K9056 13 DJO Surgical Movation Domed Patella - K100900 DJO Surgical 3DKnee Standard Poly Material - K0201 14 DJO Surgical e+ Patella HIXL VE Poly - K 113756 DJO Surgical 3DKnee Sterilization and Packaging of Standard Poly - K0201 14 DJ…
Encore Orthopedics, Inc.20025
*K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…
Summary page 1
…Tni-Peg Patella - K9056 13 DJO Surgical Movation Domed Patella - K100900 DJO Surgical 3DKnee Standard Poly Material - K0201 14 DJO Surgical e+ Patella HIXL VE Poly - K 113756 DJO Surgical 3DKnee Sterilization and Packaging of Standard Poly - K0201 14 DJO Surgical e+ Patella Sterilization and Packaging…
Encore Medical L.P.20121

Also cleared against K905613: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 20 of the 42 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K905613.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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.

Also cleared against K905613

2 other devices cite the same predicate.

  • K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 20121 recall
  • K100900Motivation Knee SystemEncore Medical L.P. · 20104 recalls

More from Encore Medical L.P.

82 FDA decisions under this applicant name. See the company

  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026
  • K252974EMPOWR KneeEncore Medical L.P. · 2025
  • K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
  • K252141AltiVate Reverse® GlenoidEncore Medical L.P. · 2025

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K121835 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121835: Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121835

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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