510(k) · Cleared
ClearedTreu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treu-Instrumente GmbH · HWC Screw, Fixation, Bone
Cleared on Jul 15, 2009 as substantially equivalent to K983006 (Stryker Osteonics, 1998) and 8 other predicates after a 197-day review. Its family tree reaches back 6 generations to 1996. 48 later devices descend from it.
- Decided
- Jul 15, 2009
- Review
- 197 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K962823 (1996). 34 ancestors in all, the oldest K792022 (1979). 48 later devices descend from it, 11 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- This deviceK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- Descendant · cites it directly · 9 of its ownK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
- Descendant · cites it directly · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- Descendant · cites it directly · 8 of its ownK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- Descendant · cites it directly · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK112254 Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets · 2012 · cites it directly9descendants
- K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · cites it directly8descendants
- K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011 · cites it directly8descendants
- K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · cites it directly5descendants
- K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co. · 2011 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| 0 (this device) | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| +1 | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical… | Medical Facets | 2012 | — |
| +1 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| +1 | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| +1 | K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | Vilex, Inc. | 2014 | — |
| +1 | K112254 | Apex Kirschner Wires and Steinmann Pins | Apex Tools & Orthopedics Co. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (9)
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 |
|---|---|---|---|
| * | K983006 | Osteo 5.0MM Cannulated Screw SystemSummary page 2…s for insertion of other im- plants. Substantial Equivalence Treu Bone Fixation Screws and Pins are substantial equivalent to the predicate devices of Stryker Osteonics K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P.… | 1998 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 2…r im- plants. Substantial Equivalence Treu Bone Fixation Screws and Pins are substantial equivalent to the predicate devices of Stryker Osteonics K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrum… | 2002 |
| * | K062103 | Darco Force Titanium Compression ScrewSummary page 2…nce Treu Bone Fixation Screws and Pins are substantial equivalent to the predicate devices of Stryker Osteonics K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K… | 2006 |
| * | K062352 | FRS ScrewSummary page 2…Pins are substantial equivalent to the predicate devices of Stryker Osteonics K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K062863, Stryker Traum [formal:Howm… | 2006 |
| * | K002605 | 4.0/2.5 MM Self-Drilling Schanz ScrewSummary page 2…uivalent to the predicate devices of Stryker Osteonics K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K062863, Stryker Traum [formal:Howmedica Osteonics Corp (U… | 2000 |
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 2…te devices of Stryker Osteonics K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K062863, Stryker Traum [formal:Howmedica Osteonics Corp (USA)] K000080. Conclusi… | 2007 |
| * | K030665 | Bone WireSummary page 2…K983006, Synthes (USA) K021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K062863, Stryker Traum [formal:Howmedica Osteonics Corp (USA)] K000080. Conclusion Based on the available 510(k)… | 2003 |
| * | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw SystemSummary page 2…021932, Darco International, Inc. K062103, DePuy Ortho- pedics Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K062863, Stryker Traum [formal:Howmedica Osteonics Corp (USA)] K000080. Conclusion Based on the available 510(k) summaries and 510(k) st… | 2006 |
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 2…Inc. K062352, Synthes (USA) K002605, OsteoMed L.P. K063298, Stork Instrumente GmbH K030665, OsteoMed (USA) K062863, Stryker Traum [formal:Howmedica Osteonics Corp (USA)] K000080. Conclusion Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the informa- tion provided herein, we… | 2000 |
What descends from it? (48)
See all 4811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless… | 2012 | 9 |
| K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | 2011 | 8 |
| K102845 | Mahe Fixation Plate and Screw System | 2011 | 8 |
| K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | 2014 | 5 |
| K112254 | Apex Kirschner Wires and Steinmann Pins | 2011 | 5 |
| K102528 | N-Force Fixation System | 2011 | 5 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| K132248 | Flower Bone Screw Set | 2013 | 1 |
| K131264 | Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws | 2013 | 1 |
| K101254 | Newfix Screw, Wire and Pin Fixarion System | 2010 | 1 |
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 13 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K112727 (Medical Facets, 2012) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K983006.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Treu Bone Fixation Screws and Pins are intended to be used as implants for the
fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for
insertion of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083912
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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