510(k) Report

510(k) · Cleared

Cleared

Ascent All-Poly PS Tibial Bearings

K021559510(k) SpecialCleared Jun 5, 200223-day reviewClass II21 CFR 888.3560

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 Jun 5, 2002 as substantially equivalent to K934589 (Kirschner Medical Corp., 1994) after a 23-day review. Its family tree reaches back 1 generation to 1994. 16 later devices descend from it.

Decided
Jun 5, 2002
Review
23 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K934589 (1994). 16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2017: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2025: 3 descendants cleared2024: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant clearedK934589 · Kirschner Performance Total Knee System Porous Coated · Kirschner Medical Corp. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 10 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K934589 · Kirschner Performance Total Knee System Porous Coated · Kirschner Medical Corp. · 19940
  1. Root · 1 generation backK934589 Kirschner Performance Total Knee System Porous CoatedKirschner Medical Corp. · 1994
  2. This deviceK021559 Ascent All-Poly PS Tibial BearingsBiomet, Inc. · 2002
  3. Descendant · cites it directly · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
  4. Descendant · 2 generations on · 7 of its ownK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
  5. Descendant · 2 generations on · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
  6. Descendant · 2 generations on · 3 of its ownK160771 Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016
  7. Descendant · 2 generations on · 2 of its ownK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2009: 22014: 12015: 12016: 12017: 22020: 12021: 12022: 12023: 12024: 12025: 32026: 1
2009high 3 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 16 · See all
  • K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · cites it directly15descendants
  • K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009 · 2 generations on7descendants
  • K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · 2 generations on6descendants
  • K160771Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016 · 2 generations on3descendants
  • K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934589Kirschner Performance Total Knee System Porous CoatedKirschner Medical Corp.1994—
0 (this device)K021559Ascent All-Poly PS Tibial BearingsBiomet, Inc.2002—
+1K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.2009—
+2K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.2009—
+2K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.2014—
+2K160771Destiknee Total Knee SystemMeril Healthcare Private Limited2016—
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201410
201510
201610
201720
202010
202110
202210
202310
202410
202530
202610
FIG. 1 — Lineage of K021559, 1994–2026Source: 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 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? (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
*K934589Kirschner Performance Total Knee System Porous Coated
Summary page 1
…lymer (21 CFR 888.3560) Device Classification: Class I1 Legally Marketed Device to which Substantially Equivalence is Claimed: Kirschner Performance Total Knee System (K934589). Device Description: The AscentTM All-Poly PS Tibial Bearings are manufactured from ArComB, an ultra-high molecular weight poly…
Kirschner Medical Corp.1994—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.200915

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?

  • Its one ancestor has no recall.
  • Of its descendants, K082019 (Maxx Orthopedics, Inc., 2009) has gone furthest, with 15 descendants of its own.

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.

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?

The AscentTMAll-Poly PS Tibial Bearings are for the painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for use with bone cement.

Indications for use as stated in the FDA summary.

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/K021559 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021559: Ascent All-Poly PS Tibial Bearings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021559

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