510(k) · Cleared
ClearedAttune Revision Sleeve LPS Femoral Adaptors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 28, 2020 as substantially equivalent to K071417 (DePuy Orthopaedics, Inc., 2007) and 1 other predicate after a 140-day review. Its family tree reaches back 4 generations to 1987. 1 of the 15 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 28, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K870730 (1987). 13 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 3 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 2 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 1 generation backK071417 Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · Recalled (Class I)
- This deviceK202248 Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC · 2020
- Descendant · cites it directly · 0 of its ownK253197 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral…Depuy Ireland UC · 2025
Class I recalls in this family
- K071417 Depuy LPS Diaphyseal and Metaphyseal Sleevesdirect predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −3 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −2 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K071417 | Depuy LPS Diaphyseal and Metaphyseal Sleeves | DePuy Orthopaedics, Inc. | 2007 | Class I |
| 0 (this device) | K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K071417 | Depuy LPS Diaphyseal and Metaphyseal SleevesSummary page 4…87 Orthopedics Regulation 21 CFR 888.3560, 21 CFR 888.3565 Product Code(s) JWH, MBH Legally marketed device(s) to Primary: K071417 Limb Preservation System Diaphyseal and Metaphyseal which equivalence is claimed Sleeves Refer… | 2007 |
| * | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System)Summary page 4…ed device(s) to Primary: K071417 Limb Preservation System Diaphyseal and Metaphyseal which equivalence is claimed Sleeves Reference: K040281 Limb Preservation System Metaphyseal Sleeves Reason for 510(k) submission The purpose of this submission is for the addition o… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | 2025 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 13.4 years on median.
- 2 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253197 (Depuy Ireland UC, 2025) has gone furthest, with 0 descendants of its own.
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. 2020, this device’s year, is highlighted.
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 DePuy LPS System 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…
Read the full statement (158 words)
The DePuy LPS System 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 System 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 metaphyseal sleeves are intended for either cemented or cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202248: Attune Revision Sleeve LPS Femoral Adaptors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202248
Report an extraction error
Are you the manufacturer?
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