510(k) Report

510(k) · Cleared

Cleared

Freedom Ultra-Congruent CR Tibial Liner

K182574510(k) SpecialCleared Jan 22, 2019126-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 Jan 22, 2019 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.

Decided
Jan 22, 2019
Review
126 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant cleared201620182020202220242026
  1. This deviceK182574 Freedom Ultra-Congruent CR Tibial LinerMaxx Orthopedics, Inc. · 2019
  2. Descendant · cites it directly · 3 of its ownK243277 Freedom® Medial Congruent LinerMaxx Orthopedics, Inc. · 2024
  3. Descendant · cites it directly · 1 of its ownK250382 Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025
  4. Descendant · cites it directly · 0 of its ownK261563 Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026
  5. Descendant · cites it directly · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025

Most influential descendants

Showing 4 of 4 · See all
  • K243277Freedom® Medial Congruent LinerMaxx Orthopedics, Inc. · 2024 · cites it directly3descendants
  • K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025 · cites it directly1descendant
  • K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026 · cites it directly0descendants
  • K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K182574Freedom Ultra-Congruent CR Tibial LinerMaxx Orthopedics, Inc.2019—
+1K243277Freedom® Medial Congruent LinerMaxx Orthopedics, Inc.2024—
+1K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.2025—
+1K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.2026—
+1K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202520
202610
FIG. 1 — Lineage of K182574, 2019–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K243277Freedom® Medial Congruent LinerMaxx Orthopedics, Inc.20243
K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251
K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260
K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250

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, K243277 (Maxx Orthopedics, Inc., 2024) has gone furthest, with 3 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. 2019, 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® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. 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, and polyarthritis.…

Read the full statement (115 words)

The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. 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, and polyarthritis.

Correction of functional deformities.

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

Moderate valgus, varus, or flexion trauma.

Knee fractures untreatable by other methods.

The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

Indications for use as stated in the FDA 510(k) statement.

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/K182574 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182574: Freedom Ultra-Congruent CR Tibial Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182574

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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