510(k) Report

510(k) · Cleared

Cleared

Ascent Knee System

K994326510(k) SpecialCleared Jan 7, 200016-day reviewClass II21 CFR 888.3720

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

Biomet Manufacturing, Inc. · KWH Prosthesis, Toe, Constrained, Polymer

Cleared on Jan 7, 2000 after a 16-day review. The FDA summary names no predicate by number. 61 later devices descend from it.

Decided
Jan 7, 2000
Review
16 days
Class
Class II
Product code
KWH
Recalls
None
Predicates
0

61 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2021: 6 descendants cleared2006: 2 descendants cleared2014: 3 descendants cleared2008: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2017: 2 descendants cleared2010: 1 descendant cleared2015: 4 descendants cleared2023: 2 descendants cleared2020: 2 descendants cleared2019: 5 descendants cleared2013: 4 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2026: 6 descendants cleared2024: 7 descendants cleared2025: 5 descendants cleared200020052010201520202025
  1. This deviceK994326 Ascent Knee SystemBiomet Manufacturing, Inc. · 2000
  2. Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  3. Descendant · 2 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  4. Descendant · 2 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  5. Descendant · 2 generations on · 13 of its ownK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
  6. Descendant · 3 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2004: 22006: 22008: 12010: 12011: 12012: 12013: 42014: 32015: 42016: 22017: 22018: 32019: 52020: 22021: 62022: 22023: 22024: 72025: 52026: 6
2004high 7 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 61 · See all
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 2 generations on47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on46descendants
  • K080361Regenerex Tibial ComponentsBiomet, Inc. · 2008 · 2 generations on13descendants
  • K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994326Ascent Knee SystemBiomet Manufacturing, Inc.2000—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
+2K080361Regenerex Tibial ComponentsBiomet, Inc.20081
+3K221479Persona Personalized Knee SystemZimmer, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200620
200810
201010
201110
201210
201340
201430
201540
201620
201720
201830
201950
202020
202160
202220
202320
202470
202550
202660
FIG. 1 — Lineage of K994326, 2000–2026Source: 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 KWH? 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 KWH device

  1. #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460

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?

  • Of its descendants, K033489 (Biomet, Inc., 2004) has gone furthest, with 60 descendants of its own.

How does its category compare?

All KWH devices

KWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWH

1in 2020

2011: 12016: 12018: 12019: 12020: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWH

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

Recalls per year · KWH

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KWH

8in 2025

2007: 22008: 42009: 52010: 32011: 22012: 62013: 52014: 62015: 62016: 62017: 32018: 72019: 152020: 82021: 52022: 52023: 62024: 22025: 8
2007high 15 (2019) · low 2 (2007)2025

MAUDE reports naming product code KWH, 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—02
20080—04
20090—25
20100—03
20111—02
20120—06
20130—05
20140—06
20150—06
20161—06
20170—03
20181—07
20191—015
20201—08
20210—05
20220—05
20230—06
20240—02
20250—08
20260—0—

What is it indicated for?

The Ascent Knee System is indicated for:

The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee, and revisions of previously failed knee replacements.

This device is for use with bone cement

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

Recent decisions in KWH

The KWH category page

  • K191966NewPrim SystemBrm Extremities · 2020
  • K190136Fusion Silastic SystemFusion Orthopedics, LLC · 2019
  • K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
  • K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016
  • K102601Orthoflex RodOrtho-Pro, LLC · 2011

https://510kreport.com/device/K994326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994326: Ascent Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994326

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026