510(k) · Cleared
ClearedFreedom® Total Knee System – Titanium Tibial Base Plate
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 Jun 26, 2025 as substantially equivalent to K090411 (Maxx Orthopedics, Inc., 2009) and 1 other predicate after a 22-day review. Its family tree reaches back 9 generations to 1998. 1 later device descends from it.
- Decided
- Jun 26, 2025
- Review
- 22 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K982302 (1998). 51 ancestors in all, the oldest K810520 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 5 generations between
- 3 generations backK153595 Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016
- 2 generations backK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
- 1 generation backK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- This deviceK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 8 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 7 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 6 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- 5 generations backK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- 4 generations backK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
- 3 generations backK153595 Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016
- 2 generations backK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
- 1 generation backK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- This deviceK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −9 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −8 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −7 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −6 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| −5 | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| −4 | K143393 | Triathlon Tritanium Cone Augments | Stryker Orthopaedics | 2015 | 1 |
| −3 | K153595 | Optetrak Logic Metaphyseal Cones | Exactech, Inc. | 2016 | — |
| −2 | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018 | — |
| −1 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| 0 (this device) | K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K090411 | Freedom Metal Backed Tibial ComponentSummary page 6…Manufacturer 510(k) Freedom® Metal Primary Predicate JWH Backed Tibial K090411 Maxx Component… | 2009 |
| * | K241597 | Freedom® Total Knee System - Porous Tibial Base PlateSummary page 6…m® Total Knee MBH, JWH Inc. Additional Predicate System – Porous K241597 Tibial Base Plate IV. DEVICE DESCRIPTION The Freedom® Total Knee System is comprised… | 2025 |
| † | K131481 | Freedom PCK Components | 2014 |
| † | K111785 | Freedom (R) Stemmed Tibial Components | 2012 |
| † | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253314 | Freedom Infinia™ Total Knee System | 2025 | 0 |
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.
- 28 of the 51 ancestors have a recall of any class.
- Of its descendants, K253314 (Maxx Orthopedics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K090411.
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. 2025, 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® 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.…
Read the full statement (97 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 and Primary PCK Components only).
The Freedom® Total Knee System – Titanium Tibial Base Plate is intended for cemented and single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251717: Freedom® Total Knee System – Titanium Tibial Base Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251717
Report an extraction error
Are you the manufacturer?
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