510(k) · Cleared

Cleared

Depuy LPS Distal Femoral Component

K063686510(k) TraditionalCleared Dec 20, 2007373-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

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

Cleared on Dec 20, 2007 as substantially equivalent to K033959 (Depuy, Inc., 2004) and 2 other predicates after a 373-day review. Its family tree reaches back 3 generations to 1987.

Decided: Dec 20, 2007
Review: 373 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K870730 (1987). 11 ancestors in all. No later device cites it as a predicate yet.

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 backK033959 LPSDepuy, Inc. · 2004
This deviceK063686 Depuy LPS Distal Femoral ComponentDePuy Orthopaedics, Inc. · 2007

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	K033959	LPS	Depuy, Inc.	2004	—
0 (this device)	K063686	Depuy LPS Distal Femoral Component	DePuy Orthopaedics, Inc.	2007	—

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
1997	2	0
1998	1	0
2002	1	0

FIG. 1 — Lineage of K063686, 1987–2007Source: 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

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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	Applicant	Decided	Recalls
*	K033959	LPS Summary page 1 …semi- constrained cemented prosthesis DEVICE PRODUCT CODE: 87 JWH SUBSTANTIALLY EQUIVALENT DePuy LPS, K033959 DEVICE: DePuy Orthogenesis LPS System, K003 182 Noiles Total Kn…	Depuy, Inc.	2004	—
*	K003182	Orthogenesis LPS System Summary page 1 …DEVICE PRODUCT CODE: 87 JWH SUBSTANTIALLY EQUIVALENT DePuy LPS, K033959 DEVICE: DePuy Orthogenesis LPS System, K003 182 Noiles Total Knee Prosthesis, K905810 DEVICE DESCRIPTION: The subject DePuy…	Depuy, Inc.	2001	—
*	K905810	Noiles (TM) Total Knee Prosthesis, Modification Summary page 1 …DePuy LPS, K033959 DEVICE: DePuy Orthogenesis LPS System, K003 182 Noiles Total Knee Prosthesis, K905810 DEVICE DESCRIPTION: The subject DePuy LPS Distal Femoral Component is a modular component that is designed to re…	Joint Medical Products Corp.	1991	—

Also cleared against K033959: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 companies; a new generation was cleared every 3.5 years on median.
2 of the 11 ancestors have a recall of any class.
2 other devices also cite its predicate K033959.

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 LPS is intended for use in 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…

Read the full statement (144 words)

* 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 cases for a failed previous prosthesis requiring extensive resection and replacement;

* severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063686 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063686: Depuy LPS Distal Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063686

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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