510(k) · Cleared
ClearedProfemur Renaissance 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 Aug 22, 2005 after a 28-day review. The FDA summary names no predicate by number. 12 later devices descend from it.
- Decided
- Aug 22, 2005
- Review
- 28 days
- Class
- Class III
- Product code
- JDL
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK051995 Profemur Renaissance Hip StemWrightmedicaltechnologyinc · 2005
- Descendant · cites it directly · 6 of its ownK072817 Echelon Titanium Hip SystemSmith & Nephew, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK110101 Taper Oxinium Femoral HeadSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK130984 Profemur Renaissance Classic Hip StemWrightmedicaltechnologyinc · 2013
- Descendant · 2 generations on · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 3 of its ownK141235 Profemur Renaissance Classic Long Neck Hip StemsMicroport Orthopedics, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072817Echelon Titanium Hip SystemSmith & Nephew, Inc. · 2008 · cites it directly6descendants
- K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc. · 2011 · 2 generations on5descendants
- K130984Profemur Renaissance Classic Hip StemWrightmedicaltechnologyinc · 2013 · cites it directly4descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · 2 generations on3descendants
- K141235Profemur Renaissance Classic Long Neck Hip StemsMicroport Orthopedics, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051995 | Profemur Renaissance Hip Stem | Wrightmedicaltechnologyinc | 2005 | — |
| +1 | K072817 | Echelon Titanium Hip System | Smith & Nephew, Inc. | 2008 | — |
| +2 | K110101 | Taper Oxinium Femoral Head | Smith & Nephew, Inc. | 2011 | — |
| +1 | K130984 | Profemur Renaissance Classic Hip Stem | Wrightmedicaltechnologyinc | 2013 | — |
| +2 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K141235 | Profemur Renaissance Classic Long Neck Hip Stems | Microport Orthopedics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 123 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, K072817 (Smith & Nephew, Inc., 2008) has gone furthest, with 6 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® RENAISSANCETI 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 ostcoarthritis, 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/K051995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051995: Profemur Renaissance Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051995
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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