510(k) · Cleared
ClearedFixion Unipolar Modular Hemi-Hip System (Fixion UH)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disc-O-Tech Medical Technologies, Ltd. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Mar 8, 2002 after an 88-day review. The FDA summary names its predicate without a number. 65 later devices descend from it.
- Decided
- Mar 8, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 0
65 later devices descend from it, 4 citing it directly.
- This deviceK014072 Fixion Unipolar Modular Hemi-Hip System (Fixion UH)Disc-O-Tech Medical Technologies, Ltd. · 2002
- Descendant · cites it directly · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- Descendant · 2 generations on · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · 2 generations on · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · 3 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · 4 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd. · 2002 · cites it directly53descendants
- K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003 · 2 generations on32descendants
- K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · 2 generations on32descendants
- K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 3 generations on31descendants
- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 4 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014072 | Fixion Unipolar Modular Hemi-Hip System (Fixion UH) | Disc-O-Tech Medical Technologies, Ltd. | 2002 | — |
| +1 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| +2 | K032588 | Modification to Fixion Intramedullary Nailing System (Fixion IM) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +2 | K031401 | Fixion Dynamic Hip Screw System (Fixion DHS) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +3 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +4 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Depuy Orthopeadics' Elite® Modular Hip System Named without a submission number | |
| * | — | Depuy Orthopeadics' S-ROM Total Hip System Named without a submission number | |
| * | — | Disc-O-Tech's Fixion™ Interlocking PF Intramedullary Nailing System Named without a submission number | |
| * | — | Link America, Inc.'s Link® Reconstruction Hip Named without a submission number | |
| * | — | Smith and Nephew’s Biolox® Alumina Ceramic Femoral Head Named without a submission number |
What descends from it? (65)
See all 654 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?
- Of its descendants, K023437 (Disco-O-Tech Medical Technologies, Ltd., 2002) has gone furthest, with 53 descendants of its own.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fixion Unipolar Modular Hemi-Hip System is intended for cemented or non-cemented use as a hemi hip replacement in cases of:
Femoral head/neck fractures or non-unions
Aseptic necrosis of the femoral head/neck
Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement
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/K014072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014072: Fixion Unipolar Modular Hemi-Hip System (Fixion UH).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014072
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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