510(k) · Cleared
ClearedFixion Unipolar Modular Hemi-Hip System (Fixion MH)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disc-O-Tech Medical Technologies, Ltd. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on May 30, 2003 as substantially equivalent to K014072 (Disc-O-Tech Medical Technologies, Ltd., 2002) and 2 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- May 30, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K970097 (1997). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 2 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 1 generation backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- This deviceK030972 Fixion Unipolar Modular Hemi-Hip System (Fixion MH)Disc-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK032730 Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −2 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −1 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| 0 (this device) | K030972 | Fixion Unipolar Modular Hemi-Hip System (Fixion MH) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +1 | K032730 | Fixion Hip System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K014072 | Fixion Unipolar Modular Hemi-Hip System (Fixion UH)Summary page 2…Disc-0-Tech Medical Technologies, Ltd. P y 2 of3 Fixion@Unipolar Modular Hemi-Hip System Predicate Devices 1. Fixion@Unipolar Modular Hemi-Hip System (K014072) by Disc-0-Tech. 2. Fixion Interlocking Proximal Femur Intramedullary Nailing System (K010988, K012967) by Disc-0-Tech. Perfo… | 2002 |
| * | K010988 | Fixion Interlocking Proximal Femoral Nailing SystemSummary page 2…i-Hip System Predicate Devices 1. Fixion@Unipolar Modular Hemi-Hip System (K014072) by Disc-0-Tech. 2. Fixion Interlocking Proximal Femur Intramedullary Nailing System (K010988, K012967) by Disc-0-Tech. Performance Standards The following standards were used: 1. IS0 7206-1 (1995): Implants for Surgery… | 2001 |
| * | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemSummary page 2…Predicate Devices 1. Fixion@Unipolar Modular Hemi-Hip System (K014072) by Disc-0-Tech. 2. Fixion Interlocking Proximal Femur Intramedullary Nailing System (K010988, K012967) by Disc-0-Tech. Performance Standards The following standards were used: 1. IS0 7206-1 (1995): Implants for Surgery - Partial a… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032730 | Fixion Hip System | 2004 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K032730 (Disc-O-Tech Medical Technologies, Ltd., 2004) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K014072.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Fixion@ MH System intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use in cases of:
Femoral head and/or neck fractures or non-unions;
Aseptic necrosis of the femoral head and/or neck;
Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with minimal acetabular iiivolvement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030972: Fixion Unipolar Modular Hemi-Hip System (Fixion MH).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030972
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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