510(k) · Cleared
ClearedProfemur TL Classic Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 8, 2013 as substantially equivalent to K060358 (Wrightmedicaltechnologyinc, 2006) after a 67-day review. Its family tree reaches back 1 generation to 2006. 5 later devices descend from it.
- Decided
- Feb 8, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060358 (2006). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK060358 Profemur TL Hip StemWrightmedicaltechnologyinc · 2006
- This deviceK123688 Profemur TL Classic Hip StemWrightmedicaltechnologyinc · 2013
- Descendant · cites it directly · 2 of its ownK191632 PROFEMUR TL2 StemsMicroport Orthopedics, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
- Descendant · 2 generations on · 0 of its ownK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK213816 MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K191632PROFEMUR TL2 StemsMicroport Orthopedics, Inc. · 2019 · cites it directly2descendants
- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
- K250444NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025 · 2 generations on0descendants
- K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants
- K213816MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060358 | Profemur TL Hip Stem | Wrightmedicaltechnologyinc | 2006 | — |
| 0 (this device) | K123688 | Profemur TL Classic Hip Stem | Wrightmedicaltechnologyinc | 2013 | — |
| +1 | K191632 | PROFEMUR TL2 Stems | Microport Orthopedics, Inc. | 2019 | — |
| +1 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +2 | K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025 | — |
| +2 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
| +2 | K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K060358 | Profemur TL Hip StemSummary page 1…) Predicate Devices: PROFEMUR® TL Hip Stem, K060358 Headquarters Tab 07: Page I of 3 W… | 2006 |
What descends from it? (5)
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?
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. 2013, 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?
The PROFEMUR® TL Classic Stems are 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…
Read the full statement (101 words)
The PROFEMUR® TL Classic Stems are 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.
The PROFEMUR® TL Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123688: Profemur TL Classic 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/K123688
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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