510(k) Report

510(k) · Cleared

Cleared

Freedom Total Knee System (E-Poly Tibial Liners)

K261563510(k) TraditionalCleared Aug 7, 202688-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 Aug 7, 2026 as substantially equivalent to K250382 (Maxx Orthopedics, Inc., 2025) and 4 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1994.

Decided
Aug 7, 2026
Review
88 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K936079 (1994). 29 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: 1 other ancestor2009: 1 other ancestor2007: 1 other ancestor2005: 2 other ancestors2003: 2 other ancestors2002: 1 other ancestor1998: 1 other ancestor2012: 1 other ancestor1997: 1 other ancestor1995: 3 other ancestors1994: 4 other ancestors1991: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor1996: 1 other ancestorReference device: K192989 · Libertas E-XLPE Modular Liner · Maxx Orthopedics, Inc. · 2020K936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K030686 · Optetrak Total Knee System - Molded Metal-Back Tibial Component · Exactech, Inc. · 2003K090411 · Freedom Metal Backed Tibial Component · Maxx Orthopedics, Inc. · 2009K131481 · Freedom PCK Components · Maxx Orthopedics, Inc. · 2014K250382 · Freedom Total Knee System (All-poly Tibial Plate) · Maxx Orthopedics, Inc. · 202519801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 9 other ancestors4 generations back: 4 other ancestors K250382 · Freedom Total Knee System (All-poly Tibial Plate) · Maxx Orthopedics, Inc. · 2025K131481 · Freedom PCK Components · Maxx Orthopedics, Inc. · 2014K090411 · Freedom Metal Backed Tibial Component · Maxx Orthopedics, Inc. · 2009K030686 · Optetrak Total Knee System - Molded Metal-Back Tibial Component · Exactech, Inc. · 2003K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994−50
  1. Root · 6 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 5 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 4 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  4. 3 generations backK090411 Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc. · 2009
  5. 2 generations backK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
  6. 1 generation backK250382 Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025
  7. This deviceK261563 Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−5K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−4K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.2003—
−3K090411Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc.2009—
−2K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.2014—
−1K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.2025—
0 (this device)K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
199110
199440
199530
199610
199710
199810
200210
200320
200520
200710
200910
201210
201910
202410
FIG. 1 — Lineage of K261563, 1994–2026Source: 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? (5)

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
*K250382Freedom Total Knee System (All-poly Tibial Plate)
Summary page 5
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K250382 Freedom Total Knee System: All-Poly Tibial Plate JWH K082019…
Maxx Orthopedics, Inc.2025—
*K082019Freedom Total Knee System
Summary page 5
…Product Code K250382 Freedom Total Knee System: All-Poly Tibial Plate JWH K082019 Freedom All-poly Tibial Baseplate JWH K090411…
Maxx Orthopedics, Inc.2009—
*K090411Freedom Metal Backed Tibial Component
Summary page 5
…JWH K082019 Freedom All-poly Tibial Baseplate JWH K090411 Freedom Metal Tibial baseplate JWH K182574…
Maxx Orthopedics, Inc.2009—
*K182574Freedom Ultra-Congruent CR Tibial Liner
Summary page 5
…JWH K090411 Freedom Metal Tibial baseplate JWH K182574 Freedom UC Tibial Liner JWH K243277…
Maxx Orthopedics, Inc.2019—
*K243277Freedom® Medial Congruent Liner
Summary page 5
…JWH K182574 Freedom UC Tibial Liner JWH K243277 Freedom MC Tibial Liner JWH Legally…
Maxx Orthopedics, Inc.2024—
†K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.2020—

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 32 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
  • 10 of the 29 ancestors have a recall of any class.

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. 2026, 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 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…

Read the full statement (131 words)

The Freedom®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, Primary PCK

Components, and Metaphyseal Cones only).

The Freedom Porous Tibial Base Plate, Cementless Femoral Components, and Metaphyseal Cones are indicated for

Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal

reconstruction.

Indications for use as stated in the FDA summary.

More from Maxx Orthopedics, Inc.

25 FDA decisions under this applicant name. See the company

  • 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
  • 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/K261563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261563: Freedom Total Knee System (E-Poly Tibial Liners).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261563

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026