510(k) · Cleared
ClearedDepuy Summit Basic Press-Fit Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Feb 5, 2003 as substantially equivalent to K000392 (DePuy Orthopaedics, Inc., 2000) after a 22-day review. Its family tree reaches back 1 generation to 2000. 28 later devices descend from it.
- Decided
- Feb 5, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000392 (2000). 28 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000392 Response 2000 Hip StemDePuy Orthopaedics, Inc. · 2000
- This deviceK030122 Depuy Summit Basic Press-Fit Hip StemDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 2 generations on · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- Descendant · 3 generations on · 15 of its ownK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- Descendant · 2 generations on · 13 of its ownK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- Descendant · 4 generations on · 7 of its ownK211703 Insignia Hip StemStryker Orthopaedics · 2021
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · cites it directly27descendants
- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · 2 generations on20descendants
- K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · 3 generations on15descendants
- K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021 · 2 generations on13descendants
- K211703Insignia Hip StemStryker Orthopaedics · 2021 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000392 | Response 2000 Hip Stem | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K030122 | Depuy Summit Basic Press-Fit Hip Stem | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +2 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| +3 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| +2 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 | — |
| +4 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K000392 | Response 2000 Hip Stem | 2000 |
What descends from it? (28)
See all 282 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?
- Its one ancestor has no recall.
- Of its descendants, K170339 (DePuy Orthopaedics, Inc., 2018) has gone furthest, with 27 descendants of its own.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
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: A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; Avascular necrosis of the…
Read the full statement (98 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:
A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
Avascular necrosis of the femoral head;
Acute traumatic fracture of the femoral head or neck;
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
Certain cases of ankylosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030122: Depuy Summit Basic Press-Fit Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030122
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