510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Offset Tibial Tray

K010212510(k) SpecialCleared Feb 14, 200122-day reviewClass II21 CFR 888.3560Recalls 3

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

Biomet, Inc. · MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Cleared on Feb 14, 2001 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it. It has been recalled 3 times.

Decided
Feb 14, 2001
Review
22 days
Class
Class II
Product code
MBV
Recalls
3
Predicates
0

24 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2011: 1 descendant cleared2017: 2 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared2015: 2 descendants cleared2019: 2 descendants cleared2021: 4 descendants cleared2025: 3 descendants cleared2022: 1 descendant cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK010212 Offset Tibial TrayBiomet, Inc. · 2001
  2. Descendant · cites it directly · 21 of its ownK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
  4. Descendant · 2 generations on · 7 of its ownK121149 Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012
  5. Descendant · cites it directly · 6 of its ownK142933 Biomet Tibial traysBiomet, Inc. · 2014 · Recalled
  6. Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 12013: 22014: 32015: 22016: 12017: 22018: 12019: 22021: 42022: 12025: 3
2010high 4 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 24 · See all
  • K093293Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · cites it directly21descendants
  • K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013 · 2 generations on10descendants
  • K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on7descendants
  • K142933Biomet Tibial traysBiomet, Inc. · 2014 · cites it directly6descendants
  • K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010212Offset Tibial TrayBiomet, Inc.2001—
+1K093293Vanguard 360 Revision Knee SystemBiomet, Inc.20105
+2K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.2013—
+2K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp2012—
+1K142933Biomet Tibial traysBiomet, Inc.20143
+1K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20174

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
201320
201430
201520
201610
201720
201810
201920
202140
202210
202530
FIG. 1 — Lineage of K010212, 2001–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MBV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K093293Vanguard 360 Revision Knee SystemBiomet, Inc.201021
K142933Biomet Tibial traysBiomet, Inc.20146
K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20175
K103837Balanced Knee System Revision Offset TibiaOrtho Development20110

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

Recalls of this device

DateClassRecallRoot causeReason
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.
Nov 15, 2012Class IIZ-0533-2013Employee errorBiomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes…
Feb 13, 2009Not classifiedZ-1061-2009Packaging process controlA 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093293 (Biomet, Inc., 2010) has gone furthest, with 21 descendants of its own.

How does its category compare?

All MBV devices

MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBV

FDA has decided no MBV device since 2007.

Median 510(k) review, days · MBV

Too few MBV 510(k)s in any year since 2007 to give a median.

Recalls per year · MBV

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · MBV

3in 2024

2009: 22011: 112012: 122013: 152014: 52015: 182016: 42017: 132018: 52019: 162020: 102021: 12022: 62023: 72024: 3
2007high 18 (2015) · low 0 (2007)2025

MAUDE reports naming product code MBV, 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
20070—00
20080—00
20090—02
20100—00
20110—011
20120—112
20130—015
20140—05
20150—018
20160—04
20170—013
20180—05
20190—016
20200—010
20210—01
20220—06
20230—07
20240—03
20250—00
20260—0—

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 MBV

The MBV category page

  • K884824Tricon-M Total Knee SystemRichards Medical Co., Inc. · 1989
  • K873429Freeman-Samuelson Mark II Press-Fit Total KneeProtek, Inc. · 1987
  • K853730Freeman-Samuelson Mark II Press-Fit Total Knee RepProtek, Inc. · 1986
  • K833200Tricon M Total Knee SystemRichards Medical Co., Inc. · 1983
  • K831441Porocoat Freeman/Samuelson Total KneeDepuy, Inc. · 1983

https://510kreport.com/device/K010212 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010212: Offset 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/K010212

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026