510(k) Report

510(k) · Cleared

Cleared

Freedom Total Knee System

K082019510(k) TraditionalCleared Feb 6, 2009205-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

Maxx Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 6, 2009 as substantially equivalent to K021559 (Biomet, Inc., 2002) and 6 other predicates after a 205-day review. Its family tree reaches back 2 generations to 1994. 15 later devices descend from it.

Decided
Feb 6, 2009
Review
205 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K934589 (1994). 11 ancestors in all, the oldest K910990 (1991). 15 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 2 other ancestors2003: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor2017: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2025: 3 descendants cleared2009: 1 descendant 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. · 1994K021559 · Ascent All-Poly PS Tibial Bearings · Biomet, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors 1 generation forward: 10 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K021559 · Ascent All-Poly PS Tibial Bearings · Biomet, Inc. · 2002K934589 · Kirschner Performance Total Knee System Porous Coated · Kirschner Medical Corp. · 19940
  1. Root · 2 generations backK934589 Kirschner Performance Total Knee System Porous CoatedKirschner Medical Corp. · 1994
  2. 1 generation backK021559 Ascent All-Poly PS Tibial BearingsBiomet, Inc. · 2002
  3. This deviceK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
  4. Descendant · cites it directly · 7 of its ownK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
  5. Descendant · cites it directly · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
  6. Descendant · cites it directly · 3 of its ownK160771 Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016
  7. Descendant · cites it directly · 2 of its ownK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
  8. Descendant · 2 generations on · 2 of its ownK172936 Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd. · 2017

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2009: 12014: 12015: 12016: 12017: 22020: 12021: 12022: 12023: 12024: 12025: 32026: 1
2009high 3 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 15 · See all
  • K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009 · cites it directly7descendants
  • K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · cites it directly6descendants
  • K160771Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016 · cites it directly3descendants
  • K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020 · cites it directly2descendants
  • K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K934589Kirschner Performance Total Knee System Porous CoatedKirschner Medical Corp.1994—
−1K021559Ascent All-Poly PS Tibial BearingsBiomet, Inc.2002—
0 (this device)K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.2009—
+1K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.2009—
+1K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.2014—
+1K160771Destiknee Total Knee SystemMeril Healthcare Private Limited2016—
+1K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.2020—
+2K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199710
199810
200320
200520
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
201510
201610
201720
202010
202110
202210
202310
202410
202530
202610
FIG. 1 — Lineage of K082019, 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
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What was it cleared against? (7)

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
*K021559Ascent All-Poly PS Tibial Bearings
Summary page 1
…semi-constrained cemented prosthesis. 3. PREDICATE DEVICES * Biomet Ascent Femoral and All-Polyethylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977).…
Biomet, Inc.2002—
*K982869Ascent System
Summary page 1
…semi-constrained cemented prosthesis. 3. PREDICATE DEVICES * Biomet Ascent Femoral and All-Polyethylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977). 4. DEVI…
Biomet, Inc.1998—
*K032829Scorpio Low Profile Tibial Tray
Summary page 1
…* Biomet Ascent Femoral and All-Polyethylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977). 4. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised of a femoral c…
Howmedica Osteonics Corp.2003—
*K030978Scorpio NRG Knee System
Summary page 1
…cent Femoral and All-Polyethylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977). 4. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised of a femoral component (crucia…
Howmedica Osteonics Corp.200311
*K042343Scorpio NRG Knee System
Summary page 1
…ral and All-Polyethylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977). 4. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised of a femoral component (cruciate ret…
Howmedica Osteonics Corp.20051
*K071991Modification to Scorpio NRG Knee System
Summary page 1
…ll-Polyethylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977). 4. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised of a femoral component (cruciate retaining an…
Howmedica Osteonics Corp.2007—
*K051977Scorpio Knee System Tibial Inserts and Patellar Components
Summary page 1
…hylene Tibial Bearing Knee System (K021559, K982869) - Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, K030978, K042343, K071991, K051977). 4. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised of a femoral component (cruciate retaining and posteri…
Howmedica Osteonics Corp.20051

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.20097
K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146
K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163
K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202
K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251
K161414Anatomic Total Knee SystemAmplitude20171
K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151
K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260
K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250
K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240

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 15 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
  • 4 of the 11 ancestors have a recall of any class.
  • Of its descendants, K091280 (Maxx Orthopedics, Inc., 2009) has gone furthest, with 7 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. 2009, this device’s year, is highlighted.

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 Freedom® Total Knee System consists of a femoral component, poly tibial component, and a patellar component. The Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:

* Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

* Correction of functional deformities.

* Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion; dysfunction, and/or prior patellectomy.

* Moderate valgus, varus, or flexion trauma.

* Knee fractures untreatable by other methods

This system is intended for cemented use'only.

Indications for use as stated in the FDA summary.

More from Maxx Orthopedics, Inc.

25 FDA decisions under this applicant name. See the company

  • K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026
  • K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
  • K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026
  • K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025
  • K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025

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/K082019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082019: Freedom Total 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/K082019

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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