510(k) · Cleared
Recalled · Class II · 2022Profemur Z Classic Stems
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 5, 2013 as substantially equivalent to K111699 (Wrightmedicaltechnologyinc, 2011) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 5, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K004043 (2001). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
- 1 generation backK111699 Profemur (R) Z Titanium Plasma Sprayed Hip StemWrightmedicaltechnologyinc · 2011
- This deviceK123434 Profemur Z Classic StemsWrightmedicaltechnologyinc · 2013
- 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 ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
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 | K004043 | Metal Transcend Articulation System | Wrightmedicaltechnologyinc | 2001 | — |
| −1 | K111699 | Profemur (R) Z Titanium Plasma Sprayed Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| 0 (this device) | K123434 | Profemur Z Classic Stems | Wrightmedicaltechnologyinc | 2013 | — |
| +1 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +2 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K111699 | Profemur (R) Z Titanium Plasma Sprayed Hip StemSummary page 1…PROFEMUR® 7 Plasma-Coated Hip Stem, KI 111699 STEM Hip Replacement System,… | 2011 |
| * | K021346 | Stem Hip Replacement System, Model PHA002XXSummary page 1…STEM Hip Replacement System, K02 1346 Headquarters Tab 07: Pape I oft3 WVrigh… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2022 | Class II | Z-1225-2022 | Process change control | One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K173898 (Microport Orthopedics Inc. (Mpo), 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K111699.
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® Z 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® Z 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® Z 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/K123434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123434: Profemur Z Classic Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123434
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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