510(k) · Cleared

Cleared

Orthogenesis LPS System

K003182510(k) TraditionalCleared Jun 27, 2001259-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, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 27, 2001 as substantially equivalent to K870730 (Joint Medical Products Corp., 1987) and 7 other predicates after a 259-day review. Its family tree reaches back 1 generation to 1987. 2 of the 72 devices in its family, counting itself, have a Class I recall. 63 later devices descend from it.

Decided: Jun 27, 2001
Review: 259 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K870730 (1987). 8 ancestors in all. 63 later devices descend from it, 8 citing it directly. 2 of the 72 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
This deviceK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
Descendant · cites it directly · 54 of its ownK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
Descendant · 2 generations on · 36 of its ownK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
Descendant · 2 generations on · 31 of its ownK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
Descendant · 3 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Descendant · 4 generations on · 23 of its ownK162422 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016

Showing 5 of 63 descendants. See all descendants

Descendants cleared per year

2004high 9 (2023) · low 0 (2005)2026

Class I recalls in this family

K041085 LPS (Limb Preservation System) Lower Extremity…cites it directly · 2004
K071417 Depuy LPS Diaphyseal and Metaphyseal Sleevescites it directly · 2007

Most influential descendants

Showing 5 of 63 · See all

K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004 · cites it directly54descendants
K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006 · 2 generations on36descendants
K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 2 generations on31descendants
K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 3 generations on27descendants
K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K870730	Noiles Total Knee Prosthesis	Joint Medical Products Corp.	1987	—
0 (this device)	K003182	Orthogenesis LPS System	Depuy, Inc.	2001	—
+1	K040281	LPS Metaphyseal Sleeve (Limb Preservation System)	DePuy Orthopaedics, Inc.	2004	—
+2	K060515	Depuy PFC Sigma Knee Prosthesis	DePuy Orthopaedics, Inc.	2006	—
+2	K063633	Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal…	DePuy Orthopaedics, Inc.	2007	1
+3	K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	—
+4	K162422	Klassic Knee System	Total Joint Orthopedics, Inc.	2016	—

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	1
2006	2	0
2007	3	1
2008	1	0
2012	2	0
2013	2	0
2014	1	0
2016	1	0
2018	4	0
2019	6	0
2020	7	0
2021	8	0
2022	4	0
2023	9	0
2024	4	0
2025	5	0
2026	1	0

FIG. 1 — Lineage of K003182, 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.

2 devices in this family have a Class I recall. 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? (8)

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
*	K870730	Noiles Total Knee Prosthesis Summary page 2 …rthogenesis LPS System is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS)…	Joint Medical Products Corp.	1987	—
*	K896048	S-Rom/Noiles Mark 3 Summary page 2 …is LPS System is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281)…	Joint Medical Products Corp.	1990	6
*	K905810	Noiles (TM) Total Knee Prosthesis, Modification Summary page 2 …stem is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the…	Joint Medical Products Corp.	1991	—
*	K924940	Femoral & Tibial Augment Block Summary page 2 …tantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica M…	Joint Medical Products Corp.	1993	—
*	K973087	Most Hex Intramedullary (I/M) Stem Summary page 2 …use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica MRS (K972401 and K965164). The determination of…	Sulzer Orthopedics, Inc.	1997	—
*	K933281	S.O.S. Proximal Femur Summary page 2 …ROM Noiles Rotating Hinge Knee (K870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica MRS (K972401 and K965164). The determination of substantial equivalence for this device was based on a detai…	Wrightmedicaltechnologyinc	1994	—
*	K972401	Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments Summary page 2 …870730, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica MRS (K972401 and K965164). The determination of substantial equivalence for this device was based on a detailed device description, product t…	Howmedica Corp.	1998	—
*	K965164	Howmedica Modular Replacement System-Proximal Femur Summary page 2 …048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica MRS (K972401 and K965164). The determination of substantial equivalence for this device was based on a detailed device description, product testing and c…	Howmedica Corp.	1997	—

Also cleared against K870730: 3 other devices →

What descends from it? (63)

See all 63

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

Number	Device	Applicant	Decided	Descendants
K040281	LPS Metaphyseal Sleeve (Limb Preservation System)	DePuy Orthopaedics, Inc.	2004	54
K033959	LPS	Depuy, Inc.	2004	3
K071417	Depuy LPS Diaphyseal and Metaphyseal Sleeves Class I	DePuy Orthopaedics, Inc.	2007	2
K081860	Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments	Zimmer, Inc.	2008	1
K233980	ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…	Depuy Ireland UC	2024	0
K211677	ELEOS Limb Salvage System	Onkos Surgical	2021	0
K063686	Depuy LPS Distal Femoral Component	DePuy Orthopaedics, Inc.	2007	0
K041085	LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Class I	Depuy, Inc.	2004	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

1 of the 8 ancestors has a recall of any class.
Of its descendants, K040281 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 54 descendants of its own.
3 other devices also cite its predicate K870730.

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	—

What is it indicated for?

The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or…

Read the full statement (153 words)

metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;

patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IID), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;

patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;

revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K003182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003182: Orthogenesis LPS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003182

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026