510(k) Report

510(k) · Cleared

Recalled · 2009

Nexgen Trabecular Metal Tibial Tray

K072160510(k) SpecialCleared Sep 5, 200730-day reviewClass II21 CFR 888.3565Recalls 1

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

Zimmer, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Sep 5, 2007 as substantially equivalent to K031061 (Zimmer, Inc., 2003) after a 30-day review. Its family tree reaches back 3 generations to 1995. 108 later devices descend from it. It has been recalled once.

Decided
Sep 5, 2007
Review
30 days
Class
Class II
Product code
MBH
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K933785 (1995). 5 ancestors in all. 108 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1999: 1 other ancestor2012: 2 descendants cleared2018: 9 descendants cleared2013: 3 descendants cleared2020: 13 descendants cleared2022: 9 descendants cleared2019: 6 descendants cleared2014: 2 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 8 descendants cleared2025: 14 descendants cleared2024: 17 descendants cleared2023: 10 descendants cleared2026: 11 descendants clearedK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK031061 · Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components · Zimmer, Inc. · 2003 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 22 descendants3 generations forward: 48 descendants4 generations forward: 24 descendants5 generations forward: 8 descendants K031061 · Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components · Zimmer, Inc. · 2003 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalled0+5
  1. Root · 3 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
  2. 2 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
  3. 1 generation backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
  4. This deviceK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007
  5. Descendant · cites it directly · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  6. Descendant · cites it directly · 51 of its ownK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
  7. Descendant · 2 generations on · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
  8. Descendant · 2 generations on · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
  9. Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2012: 22013: 32014: 22015: 22016: 12017: 12018: 92019: 62020: 132021: 82022: 92023: 102024: 172025: 142026: 11
2012high 17 (2024) · low 1 (2016)2026

Most influential descendants

Showing 5 of 108 · See all
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · cites it directly59descendants
  • K123486Triathlon Tritanium Tibial BaseplateStryker · 2013 · cites it directly51descendants
  • K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · 2 generations on38descendants
  • K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · 2 generations on28descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K933785Next Generation Knee SystemZimmer, Inc.199583
−2K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20026
−1K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200324
0 (this device)K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc.2007—
+1K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
+1K123486Triathlon Tritanium Tibial BaseplateStryker20137
+2K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics20131
+2K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics201411
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201330
201420
201520
201610
201710
201890
201960
2020130
202180
202290
2023100
2024170
2025140
2026110
FIG. 1 — Lineage of K072160, 1995–2026Source: 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 MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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? (1)

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
*K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components
Summary page 1
…21 CFR § 888.3565 Predicate Device: NexGen Porous, Uncemented Tibial Baseplates, manufactured by Zimmer, Inc., K03 106 1, cleared October 9, 2003. Device Description: The NexGen Trabecular Metal (TM)…
Zimmer, Inc.200324

Also cleared against K031061: 7 other devices →

What descends from it? (108)

See all 108

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.201259
K123486Triathlon Tritanium Tibial BaseplateStryker201351
K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221
K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189
K201084Physica systemLima Corporate S.P.A.20205
K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.20185

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 16, 2009Not classifiedZ-1064-2010OtherThe titanium portion of the implant may separate from the trabecular metal material.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
  • 5 of the 5 ancestors have a recall of any class.
  • Of its descendants, K121771 (Zimmer, Inc., 2012) has gone furthest, with 59 descendants of its own.
  • 7 other devices also cite its predicate K031061.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

This device is indicated for patients with severe knee pain and disability due to:

- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

- Collagen disorders, and/or 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.

- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).

Indications for use as stated in the FDA summary.

Also cleared against K031061

7 other devices cite the same predicate.

  • K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 20182 recalls
  • K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 201312 recalls
  • K081023Evolis Total Knee SystemMedacta International S.A. · 20081 recall
  • K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral ComponentsZimmer, Inc. · 20074 recalls
  • K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc. · 200522 recalls
  • K041100Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 20043 recalls

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

Recent decisions in MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K072160 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072160: Nexgen Trabecular Metal Tibial Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072160

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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