510(k) · Cleared
ClearedProfemur TL 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 10, 2006 after an 86-day review. The FDA summary names no predicate by number. 1 of the 70 devices in its family, counting itself, has a Class I recall. 69 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 86 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 9 citing it directly. 1 of the 70 devices in this family, counting this one, has a Class I recall.
- This deviceK060358 Profemur TL Hip StemWrightmedicaltechnologyinc · 2006
- Descendant · cites it directly · 44 of its ownK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 19 of its ownK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 16 of its ownK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK083312 Minihip StemCorin USA · 2010
- Descendant · 2 generations on · 14 of its ownK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…2 generations on · 2007
Most influential descendants
Showing 5 of 69 · See all- K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · cites it directly44descendants
- K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · 2 generations on19descendants
- K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · 3 generations on16descendants
- K083312Minihip StemCorin USA · 2010 · 2 generations on15descendants
- K081124MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060358 | Profemur TL Hip Stem | Wrightmedicaltechnologyinc | 2006 | — |
| +1 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| +2 | K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | 2008 | 1 |
| +3 | K103256 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2011 | 2 |
| +2 | K083312 | Minihip Stem | Corin USA | 2010 | — |
| +2 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2008 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (69)
See all 699 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072417 | Smith & Nephew Mis Hip Stem | 2008 | 44 |
| K112080 | Preserve Hip Stem | 2011 | 8 |
| K123688 | Profemur TL Classic Hip Stem | 2013 | 5 |
| K111910 | Gladiator Hip Stem | 2011 | 5 |
| K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology | 2007 | 5 |
| K112150 | Profemur Gladiator HA Hip Stem | 2011 | 4 |
| K110399 | Gladiator Plasma Classic Hip Stem | 2011 | 2 |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | 2018 | 1 |
| K102565 | Anterior Approach Hip Surgery Instruments | 2010 | 0 |
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.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K072417 (Smith & Nephew, Inc., 2008) has gone furthest, with 44 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.
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® TL 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/K060358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060358: Profemur TL 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/K060358
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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