510(k) Report

510(k) · Cleared

Cleared

Vanguard 360 Osseoti Tibial Sleeve Augment

K140883510(k) TraditionalCleared Jul 30, 2014114-day reviewClass II21 CFR 888.3565

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

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

Cleared on Jul 30, 2014 as substantially equivalent to K093293 (Biomet, Inc., 2010) and 3 other predicates after a 114-day review. Its family tree reaches back 5 generations to 1998.

Decided
Jul 30, 2014
Review
114 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K982302 (1998). 19 ancestors in all, the oldest K915132 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2010: 2 other ancestors2006: 1 other ancestor2005: 2 other ancestors2001: 1 other ancestor1992: 1 other ancestor2004: 2 other ancestors2003: 2 other ancestors2000: 1 other ancestor1995: 1 other ancestorK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 1998K024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK040487 · Trabecular Metal Knee System Augments · Implex Corp. · 2004 · recalledK053340 · Trabecular Metal Tibial and Femoral Cone Augments · Zimmer Trabecular · 2006K072336 · Regenerex Porous Titanium Sleeve Augments · Biomet Manufacturing Corp · 2007199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 5 other ancestors4 generations back: 2 other ancestors K072336 · Regenerex Porous Titanium Sleeve Augments · Biomet Manufacturing Corp · 2007K053340 · Trabecular Metal Tibial and Femoral Cone Augments · Zimmer Trabecular · 2006K040487 · Trabecular Metal Knee System Augments · Implex Corp. · 2004 · recalledK024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 1998−50
  1. Root · 5 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 4 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
  3. 3 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
  4. 2 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  5. 1 generation backK072336 Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp · 2007
  6. This deviceK140883 Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
−4K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20032
−3K040487Trabecular Metal Knee System AugmentsImplex Corp.20041
−2K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
−1K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp2007—
0 (this device)K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
200010
200110
200320
200420
200520
200610
201020
201210
FIG. 1 — Lineage of K140883, 1998–2014Source: 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? (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
*K093293Vanguard 360 Revision Knee System
Summary page 1
…Classification panel Orthopedic Regulation 21 CFR §888.3565 Product Code(s) _MBH, JWH Legally marketed d ''ces K093293 Vanguard 360 Revision Knee System towichequialeceis85 K121149 Vanguard SSK 360 Revision Knee System to wich…
Biomet, Inc.20105
*K121149Vanguard SSK 360 Revision Knee System
Summary page 1
…21 CFR §888.3565 Product Code(s) _MBH, JWH Legally marketed d ''ces K093293 Vanguard 360 Revision Knee System towichequialeceis85 K121149 Vanguard SSK 360 Revision Knee System to wich K072336 Regenerex Porous Titanium Sleeve Augments quivlenc is…
Biomet Manufacturing Corp2012—
*K072336Regenerex Porous Titanium Sleeve Augments
Summary page 1
…ly marketed d ''ces K093293 Vanguard 360 Revision Knee System towichequialeceis85 K121149 Vanguard SSK 360 Revision Knee System to wich K072336 Regenerex Porous Titanium Sleeve Augments quivlenc is claimed K102896 Zimmer Trabecular Metal Tibial Cone A…
Biomet Manufacturing Corp2007—
*K102896Trabecular Metal Tibial Cone Augments
Summary page 1
…5 K121149 Vanguard SSK 360 Revision Knee System to wich K072336 Regenerex Porous Titanium Sleeve Augments quivlenc is claimed K102896 Zimmer Trabecular Metal Tibial Cone Augments fr 51(k)The Reasn Vanguard 360 OsseoMi Tibial Sleeve Augm…
Zimmer Trabecular Metal Technology2010—

Also cleared against K093293: 5 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 16 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • 10 of the 19 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K093293.

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. 2014, 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?

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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…

Read the full statement (153 words)

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex and OsseoTi components are intended only for uncemented biologic fixation application.

The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States.

Indications for use as stated in the FDA summary.

Also cleared against K093293

5 other devices cite the same predicate.

  • K181947Persona Revision Knee SystemZimmer, Inc. · 20181 recall
  • K143192Vanguard 360 Revision Knee SystemBiomet, Inc. · 2015
  • K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation · 2013
  • K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
  • K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012

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 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/K140883 · printed Nov 5, 2026

Cite this page

510(k) Report. “K140883: Vanguard 360 Osseoti Tibial Sleeve Augment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140883

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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