510(k) · Cleared

Cleared

Townley Total Knee (TTK)

K904448510(k) TraditionalCleared Jul 17, 1991292-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

Biopro, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 17, 1991 after a 292-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: Jul 17, 1991
Review: 292 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

20 later devices descend from it, 6 citing it directly.

This deviceK904448 Townley Total Knee (TTK)Biopro, Inc. · 1991
Descendant · cites it directly · 12 of its ownK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
Descendant · 2 generations on · 8 of its ownK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015
Descendant · 3 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
Descendant · cites it directly · 6 of its ownK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
Descendant · 2 generations on · 4 of its ownK152726 JOURNEY II XR Knee SystemSmith & Nephew, Inc. · 2015

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013high 3 (2014) · low 0 (2018)2026

Most influential descendants

Showing 5 of 20 · See all

K141471Journey II XR Knee SystemSmith & Nephew, Inc. · 2014 · cites it directly12descendants
K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015 · 2 generations on8descendants
K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on7descendants
K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · cites it directly6descendants
K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc. · 2015 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K904448	Townley Total Knee (TTK)	Biopro, Inc.	1991	—
+1	K141471	Journey II XR Knee System	Smith & Nephew, Inc.	2014	—
+2	K152315	JOURNEY II Uni Tibial Base and Insert	Smith & Nephew, Inc.	2015	—
+3	K190085	Journey II Unicompartmental Knee System	Smith & Nephew, Inc.	2019	3
+1	K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	12
+2	K152726	JOURNEY II XR Knee System	Smith & Nephew, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2014	3	0
2015	3	0
2016	1	0
2017	1	0
2019	3	0
2020	1	0
2022	1	0
2023	1	0
2024	3	0
2026	1	0

FIG. 1 — Lineage of K904448, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K141471	Journey II XR Knee System	Smith & Nephew, Inc.	2014	12
K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	6
K132873	Vanguard XP Knee System	Biomet, Inc.	2013	3
K141407	Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial	Biomet, Inc.	2014	2
K153657	Vanguard XP Knee System	Biomet, Inc.	2016	1
K143635	KINETIS Total Knee System	Mako Surgical	2015	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, K141471 (Smith & Nephew, Inc., 2014) has gone furthest, with 12 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.

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	—

https://510kreport.com/device/K904448 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904448: Townley Total Knee (TTK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904448

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026