510(k) · Cleared
Recalled · Class I · 2013Depuy LPS Diaphyseal and Metaphyseal Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Aug 2, 2007 as substantially equivalent to K003182 (Depuy, Inc., 2001) and 2 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1987. 1 of the 15 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Aug 2, 2007
- Review
- 73 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 4 (4 Class I)
- Predicates
- 3
Its longest line of descent runs back 3 generations to K870730 (1987). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- 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 deviceK071417 Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK202248 Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC · 2020
- Descendant · 2 generations on · 0 of its ownK253197 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral…Depuy Ireland UC · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K071417 | Depuy LPS Diaphyseal and Metaphyseal Sleeves | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | 2020 | — |
| +2 | K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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…emented prosthesis DEVICE PRODUCT CODE: 87 MBH, JWH SUBSTANTIALLY EQUIVALENT DePuy Orthogenesis LPS System, K003 182 DEVICES: DePuy LPS Metaphyseal Sleeve, K040281… | 2001 |
| * | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System)Summary page 1…SUBSTANTIALLY EQUIVALENT DePuy Orthogenesis LPS System, K003 182 DEVICES: DePuy LPS Metaphyseal Sleeve, K040281 DePuy Stability Hip Stem with Porocoatt,… | 2004 |
| * | K934457 | Stability Hip Stem with PorocoatSummary page 1…seal Sleeve, K040281 DePuy Stability Hip Stem with Porocoatt, K934457 DEVICE DESCRIPTION: The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component d… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202248 | Attune Revision Sleeve LPS Femoral Adaptors | 2020 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2013 | Class I | Z-0828-2013 | Device Design | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be… |
| Jan 4, 2013 | Class I | Z-0829-2013 | Device Design | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be… |
| Jan 4, 2013 | Class I | Z-0830-2013 | Device Design | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be… |
| Jan 4, 2013 | Class I | Z-0831-2013 | Device Design | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be… |
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 3.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K202248 (Depuy Ireland UC, 2020) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K003182.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements. 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…
Read the full statement (205 words)
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
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 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.
The porous-coated diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071417: Depuy LPS Diaphyseal and 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/K071417
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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