510(k) · Cleared
ClearedProfemur LX 5/8 Coated Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on May 15, 2008 after a 29-day review. The FDA summary names no predicate by number. 1 of the 21 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 29 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- This deviceK081090 Profemur LX 5/8 Coated Hip StemWrightmedicaltechnologyinc · 2008
- Descendant · cites it directly · 14 of its ownK100866 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
- Descendant · 2 generations on · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
- Descendant · 3 generations on · 4 of its ownK150302 PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK112150 Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100866 Profemur Hip System Modular Neckscites it directly · 2010
Most influential descendants
Showing 5 of 20 · See all- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · cites it directly14descendants
- K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011 · 2 generations on8descendants
- K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · 2 generations on5descendants
- K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015 · 3 generations on4descendants
- K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081090 | Profemur LX 5/8 Coated Hip Stem | Wrightmedicaltechnologyinc | 2008 | — |
| +1 | K100866 | Profemur Hip System Modular Necks | Wrightmedicaltechnologyinc | 2010 | Class I |
| +2 | K112080 | Preserve Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| +2 | K111910 | Gladiator Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| +3 | K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics, Inc. | 2015 | — |
| +2 | K112150 | Profemur Gladiator HA Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 1 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2015 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100866 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 14 descendants of its own.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PROFEMUR® LX 5/8 Coated Hip Stem is indicated for use in total hip arthroplasty
for reduction or relief of pain and/or improved hip function in skeletally mature patients
with the following conditions:
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis,
ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed
The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip
arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081090: Profemur LX 5/8 Coated Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081090
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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