510(k) · Cleared
Recalled · Class II · 2016Pro-Femur
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 Oct 3, 2001 after a 90-day review. The FDA summary names no predicate by number. 88 later devices descend from it. It has been recalled once.
- Decided
- Oct 3, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 0
88 later devices descend from it, 9 citing it directly.
- This deviceK012091 Pro-FemurWrightmedicaltechnologyinc · 2001
- Descendant · cites it directly · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- Descendant · 2 generations on · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 53 of its ownK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- Descendant · 3 generations on · 52 of its ownK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · cites it directly68descendants
- K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · 2 generations on59descendants
- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · 2 generations on58descendants
- K111193Apex Arc Hip StemOmni Life Science, Inc. · 2011 · 3 generations on53descendants
- K113242Apex Arc Hip StemOmni Life Science, Inc. · 2012 · 3 generations on52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012091 | Pro-Femur | Wrightmedicaltechnologyinc | 2001 | — |
| +1 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +2 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| +2 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| +3 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| +3 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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?
The FDA summary names no predicate by number.
What descends from it? (88)
See all 889 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071916 | Metha Hip System | 2008 | 68 |
| K112080 | Preserve Hip Stem | 2011 | 8 |
| K111910 | Gladiator Hip Stem | 2011 | 5 |
| K112150 | Profemur Gladiator HA Hip Stem | 2011 | 4 |
| K111699 | Profemur (R) Z Titanium Plasma Sprayed Hip Stem | 2011 | 3 |
| K111698 | Profemur (R) E Cementless Hip Stem | 2011 | 2 |
| K110399 | Gladiator Plasma Classic Hip Stem | 2011 | 2 |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | 2018 | 1 |
| K041850 | Medallion Modular Hip System | 2004 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2016 | Class II | Z-0943-2017 | Process control | The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071916 (Aesculap Implant Systems, Inc., 2008) has gone furthest, with 68 descendants of its own.
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.
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?
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;
4) revision procedures where other treatments or devices have failed; and,
5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
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/K012091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012091: Pro-Femur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012091
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026