510(k) · Cleared
ClearedDynaFuse Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MedShape, Inc. · HWC Screw, Fixation, Bone
Cleared on Jan 4, 2022 as substantially equivalent to K153338 (Trilliant Surgical, Ltd., 2016) and 2 other predicates after a 391-day review. Its family tree reaches back 7 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 4, 2022
- Review
- 391 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962823 (1996). 33 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 5 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 3 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 2 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 1 generation backK153338 Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · Recalled
- This deviceK203595 DynaFuse Fixation SystemMedShape, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK233567 OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024
- Descendant · cites it directly · 0 of its ownK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260106 OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped · 2026
- Descendant · cites it directly · 0 of its ownK252699 CoAptix S SystemUniversity of Utah, Department of Orthopaedics · 2026
Most influential descendants
Showing 5 of 5 · See all- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · cites it directly1descendant
- K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024 · cites it directly1descendant
- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · cites it directly0descendants
- K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped · 2026 · 2 generations on0descendants
- K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −6 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −5 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −1 | K153338 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2016 | 4 |
| 0 (this device) | K203595 | DynaFuse Fixation System | MedShape, Inc. | 2022 | — |
| +1 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +1 | K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024 | — |
| +1 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
| +2 | K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026 | — |
| +1 | K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 4 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K153338 | Tiger Cannulated Screw SystemSummary page 4…and accessories Panel Code: 87, Orthopedic Panel Product Code: HTN E. Predicate Devices: Trilliant Surgical Tiger Cannulated Screw, K153338 (Primary) Tyber Medical Trauma Screw, K133842 and K153575 F. Referenced Predicate Devices: MedShape D… | 2016 |
| * | K133842 | Tyber Medical Trauma ScrewSummary page 4…el Product Code: HTN E. Predicate Devices: Trilliant Surgical Tiger Cannulated Screw, K153338 (Primary) Tyber Medical Trauma Screw, K133842 and K153575 F. Referenced Predicate Devices: MedShape DynaNail Mini, K182677 ________________________________… | 2014 |
| * | K153575 | Tyber Medical Trauma ScrewSummary page 4…Product Code: HTN E. Predicate Devices: Trilliant Surgical Tiger Cannulated Screw, K153338 (Primary) Tyber Medical Trauma Screw, K133842 and K153575 F. Referenced Predicate Devices: MedShape DynaNail Mini, K182677 ____________________________________________… | 2016 |
| † | K182677 | DynaNail Mini | 2019 |
What descends from it? (5)
4 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?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K254110 (MedShape, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K153338.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
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/K203595 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203595: DynaFuse Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203595
Report an extraction error
Are you the manufacturer?
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