510(k) · Cleared

Cleared

Freedom Primary PCK

K192148510(k) SpecialCleared Sep 5, 201928-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 Sep 5, 2019 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Sep 5, 2019
Review: 28 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK192148 Freedom Primary PCKMaxx Orthopedics, Inc. · 2019
Descendant · cites it directly · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx 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
0 (this device)	K192148	Freedom Primary PCK	Maxx Orthopedics, Inc.	2019	—
+1	K253314	Freedom Infinia™ Total Knee System	Maxx Orthopedics, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K192148, 2019–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K253314	Freedom Infinia™ Total Knee System	Maxx Orthopedics, Inc.	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?

Of its descendants, K253314 (Maxx Orthopedics, Inc., 2025) has gone furthest, with 0 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

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

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

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

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® Primary PCK is 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 (115 words)

The Freedom® Primary PCK is 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® Primary PCK is intended for cemented use only. This device is for single use only.

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

https://510kreport.com/device/K192148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192148: Freedom Primary PCK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192148

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