510(k) · Cleared
ClearedFreedom® Medial Congruent Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxx Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 19, 2024 as substantially equivalent to K182574 (Maxx Orthopedics, Inc., 2019) after a 34-day review. Its family tree reaches back 1 generation to 2019. 3 later devices descend from it.
- Decided
- Nov 19, 2024
- Review
- 34 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182574 (2019). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK182574 Freedom Ultra-Congruent CR Tibial LinerMaxx Orthopedics, Inc. · 2019
- This deviceK243277 Freedom® Medial Congruent LinerMaxx Orthopedics, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK250382 Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261563 Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182574 | Freedom Ultra-Congruent CR Tibial Liner | Maxx Orthopedics, Inc. | 2019 | — |
| 0 (this device) | K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | 2024 | — |
| +1 | K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026 | — |
| +1 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182574 | Freedom Ultra-Congruent CR Tibial LinerSummary page 5…21CFR 807.92(a)(3) Predicate # Predicate Trade Name Product Code K182574 Freedom Ultracongruent CR Tibial Liner JWH DEVICE DESCRIPTION SUMMARY… | 2019 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Freedom® Medial Congruent 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 (120 words)
The Freedom® Medial Congruent 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® Medial Congruent Tibial Liner is intended for cemented use only. This device is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243277: Freedom® Medial Congruent Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243277
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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