510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Biomet Knee Joint Replacement Prostheses

K171054510(k) TraditionalCleared Jul 28, 2017109-day reviewClass II21 CFR 888.3560Recalls 4

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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 28, 2017 as substantially equivalent to K912245 (Biomet, Inc., 1991) and 18 other predicates after a 109-day review. Its family tree reaches back 7 generations to 1981. 5 later devices descend from it. It has been recalled 4 times.

Decided
Jul 28, 2017
Review
109 days
Class
Class II
Product code
JWH
Recalls
4
Predicates
19

Its longest line of descent runs back 7 generations to K810258 (1981). 65 ancestors in all. 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2012: 1 other ancestor2011: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2006: 4 other ancestors2005: 3 other ancestors2004: 4 other ancestors2001: 1 other ancestor1999: 4 other ancestors1996: 3 other ancestors1993: 2 other ancestors1992: 3 other ancestors1991: 1 other ancestor2010: 1 other ancestor2003: 5 other ancestors2000: 2 other ancestors1998: 2 other ancestors1987: 1 other ancestor1984: 1 other ancestor1997: 2 other ancestors1995: 6 other ancestors1989: 1 other ancestor1986: 1 other ancestor2002: 1 other ancestor1994: 2 other ancestors2018: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant clearedK810258 · 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. · 2008K113550 · Vanguard Complete Knee System · Biomet Manufacturing Corp · 2012 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 18 other ancestors2 generations back: 18 other ancestors3 generations back: 11 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor6 generations back: 7 other ancestors7 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant K113550 · Vanguard Complete Knee System · Biomet Manufacturing Corp · 2012 · 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 · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 4 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 3 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 2 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 1 generation backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  8. This deviceK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017
  9. Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
  12. Descendant · 2 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
  13. Descendant · 3 generations on · 0 of its ownK210551 Persona Revision Knee SystemZimmer, Inc. · 2021 · Recalled

Most influential descendants

Showing 5 of 5 · See all
  • K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
  • K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 2 generations on1descendant
  • K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 2 generations on0descendants
  • K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 2 generations on0descendants
  • K210551Persona Revision Knee SystemZimmer, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−6K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−5K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−4K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−3K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−2K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−1K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
0 (this device)K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.2017—
+1K181947Persona Revision Knee SystemZimmer, Inc.20181
+2K191625Persona Revision Knee SystemZimmer, Inc.20191
+2K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.2025—
+2K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.2021—
+3K210551Persona Revision Knee SystemZimmer, Inc.20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
198710
198910
199110
199230
199320
199420
199560
199630
199720
199820
199940
200020
200110
200210
200350
200440
200530
200640
200820
200910
201010
201120
201210
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202120
202510
FIG. 1 — Lineage of K171054, 1981–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (19)

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
*K912245Agc Revision Knee Prothesis
Summary page 5
…888.3560) K171054 - Page 2 of 4 Predicate Device(s): Manufacturer: Biomet, Inc. K912245 AGC Revision Knee Prosthesis K915132 MCK (Maximum Congruent Knee) Knee System…
Biomet, Inc.19913
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 5
…ge 2 of 4 Predicate Device(s): Manufacturer: Biomet, Inc. K912245 AGC Revision Knee Prosthesis K915132 MCK (Maximum Congruent Knee) Knee System Ultra High Molecular Weight Polyethyle…
Biomet, Inc.19926
*K921182Ultra High Molecular Weight Polyethylene Component
Summary page 5
…K915132 MCK (Maximum Congruent Knee) Knee System Ultra High Molecular Weight Polyethylene K921182 Component K960856 Konstruct Patellar Component…
Biomet, Inc.19933
*K960856Konstruct Patellar Component
Summary page 5
…Ultra High Molecular Weight Polyethylene K921182 Component K960856 Konstruct Patellar Component K993159 Maxim Knee System K010…
Biomet, Inc.1996—
*K993159Maxim Knee System
Summary page 5
…K921182 Component K960856 Konstruct Patellar Component K993159 Maxim Knee System K010212 Offset Tibial Tray…
Biomet, Inc.1999—
*K010212Offset Tibial Tray
Summary page 5
…omponent K960856 Konstruct Patellar Component K993159 Maxim Knee System K010212 Offset Tibial Tray AGC Total Knee System, Ascent Total Knee…
Biomet, Inc.20013
*K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…
Summary page 5
…K010212 Offset Tibial Tray AGC Total Knee System, Ascent Total Knee K033489 System, Maxim Complete Knee System, Maxim Accel Knee System…
Biomet, Inc.2004—
*K040770Vanguard Patella Components
Summary page 5
…K033489 System, Maxim Complete Knee System, Maxim Accel Knee System K040770 Vanguard Patella Components K042757 Vanguard SSK Knee System…
Biomet Manufacturing, Inc.200413
*K042757Vanguard SSK Knee System
Summary page 5
…em, Maxim Accel Knee System K040770 Vanguard Patella Components K042757 Vanguard SSK Knee System K060525 Vanguard Removable Molded Poly Tibia…
Biomet, Inc.20051
*K060525Vanguard Removable Molded Poly Tibia
Summary page 5
…em K040770 Vanguard Patella Components K042757 Vanguard SSK Knee System K060525 Vanguard Removable Molded Poly Tibia K080204 Vanguard Knee System Titanium Femoral…
Biomet Manufacturing Corp20063
*K080204Vanguard Knee System Titanium Femoral Components
Summary page 5
…K042757 Vanguard SSK Knee System K060525 Vanguard Removable Molded Poly Tibia K080204 Vanguard Knee System Titanium Femoral Components K0…
Biomet, Inc.2008—
*K080361Regenerex Tibial Components
Summary page 5
…Tibia K080204 Vanguard Knee System Titanium Femoral Components K080361 Regenerex Tibial Components K083782 Regenerex Patella Components…
Biomet, Inc.20081
*K083782Regenerex Patella Components
Summary page 5
…Titanium Femoral Components K080361 Regenerex Tibial Components K083782 Regenerex Patella Components K102125 Patient-Specific Vanguard Femoral Components…
Biomet Manufacturing Corp20092
*K102125Patient-Specific Vanguard Femoral Componets
Summary page 5
…K080361 Regenerex Tibial Components K083782 Regenerex Patella Components K102125 Patient-Specific Vanguard Femoral Components K110362 Vanguard Asymmetrical Patellar Com…
Biomet, Inc.2011—
*K110362Vanguard Asymmetrical Patellar Component
Summary page 5
…K083782 Regenerex Patella Components K102125 Patient-Specific Vanguard Femoral Components K110362 Vanguard Asymmetrical Patellar Component K113550 Vanguard Complete Knee System…
Biomet Manufacturing Corp2011—
*K113550Vanguard Complete Knee System
Summary page 5
…02125 Patient-Specific Vanguard Femoral Components K110362 Vanguard Asymmetrical Patellar Component K113550 Vanguard Complete Knee System K121149 Vanguard SSK 360 Revision Knee System…
Biomet Manufacturing Corp20127
*K121149Vanguard SSK 360 Revision Knee System
Summary page 5
…K110362 Vanguard Asymmetrical Patellar Component K113550 Vanguard Complete Knee System K121149 Vanguard SSK 360 Revision Knee System E1 Series A Patellae, Standard 3-Peg, E1…
Biomet Manufacturing Corp2012—
*K140902E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series…
Summary page 5
…149 Vanguard SSK 360 Revision Knee System E1 Series A Patellae, Standard 3-Peg, E1 Series A K140902 Patellae, Thin 3-Peg, E-1 Series A Patellae, Asymmetrical, 3-Peg…
Biomet, Inc.2014—
*K142933Biomet Tibial trays
Summary page 5
…K140902 Patellae, Thin 3-Peg, E-1 Series A Patellae, Asymmetrical, 3-Peg K142933 Biomet Tibial Trays Summary of Technological Characteristics: The purpose of this submission is the addition of…
Biomet, Inc.20143

Also cleared against K912245: 6 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181947Persona Revision Knee SystemZimmer, Inc.20184

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 21, 2018Class IIZ-0938-2019Under Investigation by firmVanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
May 24, 2018Class IIZ-2289-2018Under Investigation by firmTwo lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
May 18, 2018Class IIZ-2177-2018Under Investigation by firmOne lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
May 11, 2018Class IIZ-2183-2018Under Investigation by firmThe label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • 25 of the 65 ancestors have a recall of any class.
  • Of its descendants, K181947 (Zimmer, Inc., 2018) has gone furthest, with 4 descendants of its own.
  • 6 other devices also cite its predicate K912245.

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. 2017, 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?

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments…

Read the full statement (137 words)

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.

Regenerex components are intended only for uncemented biologic fixation application.

The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K912245

6 other devices cite the same predicate.

  • K094013HLS Kneetec SystemTornier · 2011
  • K080361Regenerex Tibial ComponentsBiomet, Inc. · 20081 recall
  • K06134023 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc. · 2006
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System…Biomet, Inc. · 2004
  • K040770Vanguard Patella ComponentsBiomet Manufacturing, Inc. · 200413 recalls
  • K984054Agc V2 Revision Knee SystemBiomet, Inc. · 1999

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K171054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171054: Biomet Knee Joint Replacement Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171054

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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