510(k) Report

510(k) · Cleared

Cleared

Freedom Infinia™ Total Knee System

K253314510(k) SpecialCleared Oct 29, 202529-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 Oct 29, 2025 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 9 other predicates after a 29-day review. Its family tree reaches back 10 generations to 1998.

Decided
Oct 29, 2025
Review
29 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
10

Its longest line of descent runs back 10 generations to K982302 (1998). 72 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2024: 1 other ancestor2019: 2 other ancestors2015: 1 other ancestor2014: 2 other ancestors2012: 2 other ancestors2009: 3 other ancestors2007: 2 other ancestors2005: 6 other ancestors2003: 8 other ancestors2002: 2 other ancestors1998: 2 other ancestors2013: 1 other ancestor2001: 2 other ancestors1997: 1 other ancestor1995: 4 other ancestors1994: 7 other ancestors1991: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor2010: 1 other ancestor2004: 4 other ancestors1999: 3 other ancestors1996: 2 other ancestors1993: 1 other ancestor2006: 1 other ancestor2000: 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 · 2006K100391 · Depuy Universal Gription TF Cones · DePuy Orthopaedics, Inc. · 2010K143393 · Triathlon Tritanium Cone Augments · Stryker Orthopaedics · 2015 · recalledK153595 · Optetrak Logic Metaphyseal Cones · Exactech, Inc. · 2016K182346 · TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws · Exactech, Inc. · 2018×2: 2 generations cleared close together, K241597 (2025), K251717 (2025) 19801990200020102020
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 9 other ancestors3 generations back: 13 other ancestors4 generations back: 10 other ancestors5 generations back: 11 other ancestors6 generations back: 8 other ancestors7 generations back: 3 other ancestors K251717 · Freedom® Total Knee System – Titanium Tibial Base Plate · Maxx Orthopedics, Inc. · 2025K241597 · Freedom® Total Knee System - Porous Tibial Base Plate · Maxx Orthopedics, Inc. · 2025K182346 · TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws · Exactech, Inc. · 2018K153595 · Optetrak Logic Metaphyseal Cones · Exactech, Inc. · 2016K143393 · Triathlon Tritanium Cone Augments · Stryker Orthopaedics · 2015 · recalledK100391 · Depuy Universal Gription TF Cones · DePuy Orthopaedics, Inc. · 2010K053340 · 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. · 1998−10−50
  1. Root · 10 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 6 generations between
  3. 3 generations backK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
  4. 2 generations backK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
  5. 1 generation backK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
  6. This deviceK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
Show all 10 generations
  1. Root · 10 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 9 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
  3. 8 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
  4. 7 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  5. 6 generations backK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  6. 5 generations backK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
  7. 4 generations backK153595 Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016
  8. 3 generations backK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
  9. 2 generations backK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
  10. 1 generation backK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
  11. This deviceK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
−9K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20032
−8K040487Trabecular Metal Knee System AugmentsImplex Corp.20041
−7K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
−6K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
−5K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics20151
−4K153595Optetrak Logic Metaphyseal ConesExactech, Inc.2016—
−3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.2018—
−2K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.2025—
−1K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.2025—
0 (this device)K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
199110
199310
199470
199540
199620
199710
199820
199930
200010
200120
200220
200380
200440
200560
200610
200720
200930
201010
201220
201310
201420
201510
201920
202410
FIG. 1 — Lineage of K253314, 1998–2025Source: 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 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? (10)

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
*K082019Freedom Total Knee System
Summary page 6
…Manufacturer 510(k) Primary Predicate Freedom® Total Knee JWH K082019 System Freedom® Total Knee Additional Predicate…
Maxx Orthopedics, Inc.2009—
*K090411Freedom Metal Backed Tibial Component
Summary page 6
…System Freedom® Total Knee Additional Predicate JWH Metal Backed Tibial K090411 Components Maxx Additional Predicate Freedom® St…
Maxx Orthopedics, Inc.2009—
*K111785Freedom (R) Stemmed Tibial Components
Summary page 6
…x Additional Predicate Freedom® Stemmed Tibial Orthopedics JWH K111785 Components Inc. Additional Predicate Freedom®…
Maxx Orthopedics, Inc.2012—
*K131481Freedom PCK Components
Summary page 6
…Inc. Additional Predicate Freedom® PCK JWH K131481 Components Additional Predicate Freedom® Cementless…
Maxx Orthopedics, Inc.2014—
*K150680Freedom Cementless Femoral Component
Summary page 6
…Components Additional Predicate Freedom® Cementless MBH K150680 Femoral Components Additional Predicate Freedom® Ultra-…
Maxx Orthopedics, Inc.2015—
*K182574Freedom Ultra-Congruent CR Tibial Liner
Summary page 6
…oral Components Additional Predicate Freedom® Ultra- JWH K182574 Congruent CR Tibial Liner 510(k) S…
Maxx Orthopedics, Inc.2019—
*K192148Freedom Primary PCK
Summary page 7
…Trade Name Manufacturer 510(k) Additional Predicate JWH Freedom® Primary PCK K192148 Freedom® Total Knee Additional Predicate MBH System - Porous Tibial…
Maxx Orthopedics, Inc.2019—
*K241597Freedom® Total Knee System - Porous Tibial Base Plate
Summary page 7
…K192148 Freedom® Total Knee Additional Predicate MBH System - Porous Tibial K241597 Base Plate Additional Predicate Freedom® Medial…
Maxx Orthopedics, Inc.2025—
*K243277Freedom® Medial Congruent Liner
Summary page 7
…Base Plate Additional Predicate Freedom® Medial JWH K243277 Congruent Liner Freedom® Total Knee Additional Pr…
Maxx Orthopedics, Inc.2024—
*K251717Freedom® Total Knee System – Titanium Tibial Base Plate
Summary page 7
…Congruent Liner Freedom® Total Knee Additional Predicate JWH System - Titanium Tibial K251717 Base Plate IV. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised of a femo…
Maxx Orthopedics, Inc.2025—

Also cleared against K082019: 9 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 27 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
  • 33 of the 72 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K082019.

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. 2025, 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 Infinia™ Total Knee System is indicated for the following: • 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, or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable…

Read the full statement (123 words)

The Freedom Infinia™ Total Knee System is indicated for the following:

• 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, or prior patellectomy.

• Moderate valgus, varus, or flexion trauma.

• Knee fractures untreatable by other methods.

• Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)

The Freedom Infinia™ Total Knee System components are intended for cemented and single use only. The Freedom Infinia™ Cementless Femoral (CR and PS) Components and Porous Tibial Base Plates are additionally indicated for cementless biological fixation application

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

Also cleared against K082019

9 other devices cite the same predicate.

  • K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026
  • K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025
  • K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc. · 2024
  • K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
  • K161414Anatomic Total Knee SystemAmplitude · 2017
  • K160771Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016

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
  • K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx 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/K253314 · printed Nov 5, 2026

Cite this page

510(k) Report. “K253314: Freedom Infinia™ Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253314

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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