510(k) · Cleared
ClearedPROFEMUR TL2 Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 7, 2019 as substantially equivalent to K123688 (Wrightmedicaltechnologyinc, 2013) after a 110-day review. Its family tree reaches back 2 generations to 2006. 2 later devices descend from it.
- Decided
- Oct 7, 2019
- Review
- 110 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060358 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK060358 Profemur TL Hip StemWrightmedicaltechnologyinc · 2006
- 1 generation backK123688 Profemur TL Classic Hip StemWrightmedicaltechnologyinc · 2013
- This deviceK191632 PROFEMUR TL2 StemsMicroport Orthopedics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK213816 MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060358 | Profemur TL Hip Stem | Wrightmedicaltechnologyinc | 2006 | — |
| −1 | K123688 | Profemur TL Classic Hip Stem | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | K191632 | PROFEMUR TL2 Stems | Microport Orthopedics, Inc. | 2019 | — |
| +1 | K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025 | — |
| +1 | K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K123688 | Profemur TL Classic Hip StemSummary page 4…Class: Class II Panel Code: Orthopedics/87 Product Code: LZO Predicate Device: PROFEMUR® TL CLASSIC HIP STEM (K123688, SE 02/08/2013) This predicate has not been subject to a design-related… | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250444 (Microport Orthopedics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123688.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
PROFEMUR® TL2 stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
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
Titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191632 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191632: PROFEMUR TL2 Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191632
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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