510(k) · Cleared
ClearedLPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 1, 2004 as substantially equivalent to K003182 (Depuy, Inc., 2001) and 2 other predicates after a 192-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 192 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K870730 (1987). 10 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 1 generation backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- This deviceK033959 LPSDepuy, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK233980 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb…Depuy Ireland UC · 2024
- Descendant · cites it directly · 0 of its ownK063686 Depuy LPS Distal Femoral ComponentDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK062301 Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC · 2024 · cites it directly0descendants
- K063686Depuy LPS Distal Femoral ComponentDePuy Orthopaedics, Inc. · 2007 · cites it directly0descendants
- K062301Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −1 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| 0 (this device) | K033959 | LPS | Depuy, Inc. | 2004 | — |
| +1 | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation… | Depuy Ireland UC | 2024 | — |
| +1 | K063686 | Depuy LPS Distal Femoral Component | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K062301 | Depuy LPS Proximal Tibial Component | DePuy Orthopaedics, Inc. | 2006 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K003182 | Orthogenesis LPS SystemSummary page 1…prosthesis: Class II per 21 CFR §888.3350 Product Code: 87 JWH, 87 JD[ C. Indications for Use (changes are in bold from those cleared in K003182): The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total… | 2001 |
| * | K870730 | Noiles Total Knee ProsthesisSummary page 2…design, sterilization and packaging to the LPS (K003 182 cleared on June 27, 2001). * in materials to the S-ROM Noiles Rotating Hinge Knee (K870730 cleared on May 26, 1987), * in indications for use to the Howmedica Global Modular Replacement Syste… | 1987 |
| * | K023087 | Global Modular Replacement System (GMRS)Summary page 2…e Knee (K870730 cleared on May 26, 1987), * in indications for use to the Howmedica Global Modular Replacement System (GMRS) (K023087 cleared on December 16, 2002). The determination of substantial equivalence for this device was based on a detailed devic… | 2002 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K233980 (Depuy Ireland UC, 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K003182.
How does its category compare?
All JWH devicesJWH 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 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 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 joint…
Read the full statement (146 words)
The 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 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 distal femoral component, the tibial components, 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/K033959 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033959: LPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033959
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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