510(k) · Cleared
ClearedLPS Metaphyseal Sleeve (Limb Preservation System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 9, 2004 as substantially equivalent to K003182 (Depuy, Inc., 2001) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1987. 1 of the 64 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it.
- Decided
- Jul 9, 2004
- Review
- 154 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K870730 (1987). 9 ancestors in all. 54 later devices descend from it, 4 citing it directly. 1 of the 64 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 1 generation backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- This deviceK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- Descendant · cites it directly · 36 of its ownK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 31 of its ownK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- Descendant · 3 generations on · 23 of its ownK162422 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016
- Descendant · 3 generations on · 22 of its ownK180159 Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071417 Depuy LPS Diaphyseal and Metaphyseal Sleevescites it directly · 2007
Most influential descendants
Showing 5 of 54 · See all- K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006 · cites it directly36descendants
- K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · cites it directly31descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants
- K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016 · 3 generations on23descendants
- K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018 · 3 generations on22descendants
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) | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| +1 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal… | DePuy Orthopaedics, Inc. | 2007 | 1 |
| +2 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| +3 | K162422 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2016 | — |
| +3 | K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | 2018 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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.
1 device in this family has 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
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 | Decided |
|---|---|---|---|
| * | K003182 | Orthogenesis LPS SystemSummary page 3…al Equivalence: The substantial equivalence of the LPS is substantiated by its similarity: * in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). * in design, materials and indications for use to the femoral sleeve found in the S-… | 2001 |
| * | K870730 | Noiles Total Knee ProsthesisSummary page 3…ared on June 27, 2001). * in design, materials and indications for use to the femoral sleeve found in the S- ROM/Noiles PS Total Knee System (K870730 cleared on May 26, 1987). el DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1987 |
What descends from it? (54)
See all 544 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K060515 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 36 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 metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases across several product lines: the Limb Preservation System (LPS), the S-ROM Modular Knee system, and the P.F.C. Sigma system. The previously cleared indications for use for these systems are the…
Read the full statement (379 words)
The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases across several product lines: the Limb Preservation System (LPS), the S-ROM Modular Knee system, and the P.F.C. Sigma system. The previously cleared indications for use for these systems are the following:
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 metaphyseal sleeve, the distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.
The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee."
The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients:
* who have reached skeletal maturity and
* for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.
The P.F.C.® Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.
This damage may also be a result of trauma or failed prior surgical intervention.
The P.F.C.® Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040281: LPS Metaphyseal Sleeve (Limb Preservation System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040281
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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