510(k) · Cleared
ClearedProfemur S Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Cleared on Jul 9, 2004 after a 25-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 9, 2004
- Review
- 25 days
- Class
- Class III
- Product code
- JDL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JDL? 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? (3)
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 |
|---|---|---|---|
| * | — | PERFECTA® RS Hip Stem Named without a submission number | |
| * | — | PROFEMUR® R Hip Stem Named without a submission number | |
| * | — | PROFEMUR® Tapered Hip Stem Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All JDL devicesJDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDL
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · JDL
Too few JDL 510(k)s in any year since 2007 to give a median.
Recalls per year · JDL
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDL
16in 2025
MAUDE reports naming product code JDL, 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 | 1 | — | 0 | 79 |
| 2008 | 1 | — | 0 | 67 |
| 2009 | 0 | — | 2 | 104 |
| 2010 | 0 | — | 1 | 198 |
| 2011 | 0 | — | 0 | 271 |
| 2012 | 0 | — | 0 | 338 |
| 2013 | 0 | — | 0 | 496 |
| 2014 | 0 | — | 0 | 519 |
| 2015 | 0 | — | 0 | 466 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 0 | — | 0 | 336 |
| 2018 | 0 | — | 0 | 205 |
| 2019 | 0 | — | 0 | 140 |
| 2020 | 0 | — | 0 | 94 |
| 2021 | 0 | — | 0 | 68 |
| 2022 | 0 | — | 0 | 49 |
| 2023 | 0 | — | 0 | 32 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The PROFEMUR® S 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041586 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041586: Profemur S 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/K041586
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026