510(k) · Cleared
ClearedFreedom PCK Components
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 Feb 21, 2014 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 2 other predicates after a 275-day review. Its family tree reaches back 4 generations to 1994. 6 later devices descend from it.
- Decided
- Feb 21, 2014
- Review
- 275 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K936079 (1994). 25 ancestors in all, the oldest K810520 (1981). 6 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 3 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 2 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 1 generation backK090411 Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc. · 2009
- This deviceK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK250382 Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK150680 Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 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
- Descendant · cites it directly · 0 of its ownK253144 Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025 · cites it directly1descendant
- K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc. · 2015 · cites it directly1descendant
- K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026 · 2 generations on0descendants
- K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025 · cites it directly0descendants
- K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −3 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −2 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −1 | K090411 | Freedom Metal Backed Tibial Component | Maxx Orthopedics, Inc. | 2009 | — |
| 0 (this device) | K131481 | Freedom PCK Components | Maxx Orthopedics, Inc. | 2014 | — |
| +1 | K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics, Inc. | 2015 | — |
| +2 | K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026 | — |
| +1 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K082019 | Freedom Total Knee SystemSummary page 1…Code Number number Fredor@ TtalKne sytemif WH 21 CFR § K082019, Freeom®Totl Kee sste IIJWH 888.3560 K090411I Free… | 2009 |
| * | K090411 | Freedom Metal Backed Tibial ComponentSummary page 1…WH 21 CFR § K082019, Freeom®Totl Kee sste IIJWH 888.3560 K090411I Freedom® Stemmed Tibial HJ 21 CFR § K111785 Components… | 2009 |
| * | K111785 | Freedom (R) Stemmed Tibial ComponentsSummary page 1…Kee sste IIJWH 888.3560 K090411I Freedom® Stemmed Tibial HJ 21 CFR § K111785 Components 888.3560 1… | 2012 |
What descends from it? (6)
5 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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 10 of the 25 ancestors have a recall of any class.
- Of its descendants, K250382 (Maxx Orthopedics, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K082019.
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. 2014, 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® PCK Components are designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom Total Knee System, and 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…
Read the full statement (126 words)
The Freedom® PCK Components are designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom Total Knee System, and 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, and/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
The Freedom® PCK Components are intended for cemented use only. The optional Freedom Stemmed Tibial Augments are intended for screw attachment to the Stemmed Tibial Base Plate. This device is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131481: Freedom PCK Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131481
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