510(k) · Cleared
ClearedProfemur Tapered 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 May 28, 2004 after a 30-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- May 28, 2004
- Review
- 30 days
- Class
- Class III
- Product code
- JDL
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK041114 Profemur Tapered Hip StemWrightmedicaltechnologyinc · 2004
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- Descendant · 2 generations on · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 3 of its ownK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 2 generations on4descendants
- K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · 2 generations on4descendants
- K191374Revival Modular Hip StemCorin U.S.A. Limited · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041114 | Profemur Tapered Hip Stem | Wrightmedicaltechnologyinc | 2004 | — |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +2 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| +2 | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
| +2 | K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | — | PROFEMUR® Z Hip Stem Named without a submission number | |
| * | — | PERFECTA® RS Hip Stem Named without a submission number | |
| * | — | PERFECTA® Plasma Sprayed Hip Stem Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads | 2012 | 13 |
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, K112158 (Lima Corporate S.P.A., 2012) has gone furthest, with 13 descendants of its own.
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® Tapered 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/K041114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041114: Profemur Tapered 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/K041114
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