510(k) · Cleared
ClearedPerfecta and Extend
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 15, 2001 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 15, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK004032 Perfecta and ExtendWrightmedicaltechnologyinc · 2001
- Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
- Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK031402 Perfecta Femoral StemWrightmedicaltechnologyinc · 2004
Most influential descendants
Showing 3 of 3 · See all- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
- K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants
- K031402Perfecta Femoral StemWrightmedicaltechnologyinc · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K004032 | Perfecta and Extend | Wrightmedicaltechnologyinc | 2001 | — |
| +1 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +2 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
| +1 | K031402 | Perfecta Femoral Stem | Wrightmedicaltechnologyinc | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 24.2 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K173898 (Microport Orthopedics Inc. (Mpo), 2018) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K004032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K004032: Perfecta and Extend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K004032
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026