510(k) · Cleared

Recalled · Class II · 2021

Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves

K063633510(k) TraditionalCleared Mar 2, 200786-day reviewClass II21 CFR 888.3560Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Mar 2, 2007 as substantially equivalent to K040281 (DePuy Orthopaedics, Inc., 2004) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1987. 31 later devices descend from it. It has been recalled once.

Decided: Mar 2, 2007
Review: 86 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 2

Its longest line of descent runs back 3 generations to K870730 (1987). 11 ancestors in all. 31 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
2 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
1 generation backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
This deviceK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007
Descendant · cites it directly · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Descendant · 2 generations on · 23 of its ownK162422 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016
Descendant · 2 generations on · 22 of its ownK180159 Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018
Descendant · 3 generations on · 15 of its ownK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
Descendant · 4 generations on · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2014high 8 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 31 · See all

K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · cites it directly27descendants
K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016 · 2 generations on23descendants
K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018 · 2 generations on22descendants
K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019 · 3 generations on15descendants
K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · 4 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K870730	Noiles Total Knee Prosthesis	Joint Medical Products Corp.	1987	—
−2	K003182	Orthogenesis LPS System	Depuy, Inc.	2001	—
−1	K040281	LPS Metaphyseal Sleeve (Limb Preservation System)	DePuy Orthopaedics, Inc.	2004	—
0 (this device)	K063633	Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal…	DePuy Orthopaedics, Inc.	2007	—
+1	K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	—
+2	K162422	Klassic Knee System	Total Joint Orthopedics, Inc.	2016	—
+2	K180159	Klassic® Knee System	Total Joint Orthopedics, Inc.	2018	—
+3	K190562	iTotal Identity Cruciate Retaining Knee Replacement System	Conformis, Inc.	2019	—
+4	K201023	iTotal® Identity Posterior Stabilized Knee Replacement System	Conformis, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0
1993	1	0
1994	1	0
1995	1	0
1997	2	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0
2018	1	0
2019	4	0
2020	3	0
2021	6	0
2022	3	0
2023	8	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K063633, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K040281	LPS Metaphyseal Sleeve (Limb Preservation System) Summary page 1 …: 87 JWH SUBSTANTIALLY EQUIVALENT DEVICES: I lniversal Femoral Metaphyseal Sleeve Components: DePuy LPS Knee System (K040281, cleared July 9,2004) I lniversal Stem Fxtensiong S-ROM/NoilesTM PS Total Knee System…	DePuy Orthopaedics, Inc.	2004	—
*	K941769	Knee Prothesis Summary page 1 …Knee System (K040281, cleared July 9,2004) I lniversal Stem Fxtensiong S-ROM/NoilesTM PS Total Knee System (K941769, cleared February 1, 1995) DEVICE DESCRIPTIONS: DePuy is offering the DePuy Universal Femoral Metaphyseal Sleeve and th…	Joint Medical Products Corp.	1995	—

Also cleared against K040281: 3 other devices →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	27
K182301	PFC SIGMA Knee System	DePuy Orthopaedics, Inc.	2019	1
K241000	ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…	Depuy Ireland UC	2024	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 8, 2021	Class II	Z-1103-2021	Nonconforming Material/Component	The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
1 of the 11 ancestors has a recall of any class.
Of its descendants, K140942 (Total Joint Orthopedics, Inc., 2014) has gone furthest, with 27 descendants of its own.
3 other devices also cite its predicate K040281.

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. 2007, 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 DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, Sigma PFC, Sigma TC3 Revision Knee, or S-ROM knee prostheses in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.…

Read the full statement (220 words)

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are

intended for use with the PFC, Sigma PFC, Sigma TC3 Revision Knee, or S-ROM knee

prostheses in total knee replacement surgery for patients suffering from severe pain and

disability due to permanent structural damage resulting from rheumatoid arthritis,

osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed

prior surgical intervention. These devices are intended for cemented use only.

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are

also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft

portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in

cases that require extensive resection and replacement. Specific diagnostic indications

for use include: Malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell

tumors, bone tumors) requiring extensive resection and replacement; patient conditions of

noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis,

osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring

extensive resection and replacement; revision for failed previous prosthesis cases

requiring extensive resection and replacement; severe trauma requiring extensive

resection and replacement. The LPS prosthesis is also intended for use in bone loss post-

infection, where the surgeon has elected to excise the bone and replacement is required.

The Universal Stem and the Universal Metaphyseal Sleeve component are intended for

cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063633 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063633

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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