510(k) · Cleared
ClearedModification to Depuy Solution System Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 24, 2003 as substantially equivalent to K953703 (Depuy, Inc., 1996) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1994. 10 later devices descend from it.
- Decided
- Apr 24, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931641 (1994). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 2 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 1 generation backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- This deviceK030979 Modification to Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK060581 Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK102080 Depuy Reclaim Revision Hip SystemDepuy (Ireland) · 2010 · Recalled
- Descendant · 3 generations on · 6 of its ownK221462 DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC · 2022
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K060581Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc. · 2006 · cites it directly9descendants
- K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland) · 2010 · 2 generations on7descendants
- K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC · 2022 · 3 generations on6descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −2 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −1 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| 0 (this device) | K030979 | Modification to Depuy Solution System Hip Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K060581 | Depuy Solution System Hip Prosthesis | DePuy Orthopaedics, Inc. | 2006 | 20 |
| +2 | K102080 | Depuy Reclaim Revision Hip System | Depuy (Ireland) | 2010 | 3 |
| +3 | K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | Depuy Ireland UC | 2022 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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.
Planning a device in LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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 |
|---|---|---|---|
| * | K953703 | Depuy Vision Solution Hip ProsthesisSummary page 1…thesis DEVICE PRODUCT CODE: 87LPH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Vision Solution Hip Prosthesis, K953703 DePuy AML Hip Prosthesis, KO12364 DEVICE DESCRIPTION: The DePuy Solution System Hi… | 1996 |
| * | K012364 | Aml Hip Prosthesis | 2001 |
What descends from it? (10)
2 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 9 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K060581 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K953703.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful andor disabled joint from osteoarthntis, traumatic arthritis, rheumatoid arthntis, or congenital hip dysplasia. 2. Avascular necrosis of…
Read the full statement (151 words)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
1. A severely painful andor disabled joint from osteoarthntis, traumatic arthritis, rheumatoid arthntis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The DePuy Solution System Hip System is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030979: Modification to Depuy Solution System Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030979
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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