510(k) · Cleared
ClearedOsteomed Headless Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · HWC Screw, Fixation, Bone
Cleared on Mar 2, 2007 as substantially equivalent to K060071 (Nexa Orthopedics, Inc., 2006) and 4 other predicates after a 121-day review. Its family tree reaches back 5 generations to 1996. 1 of the 261 devices in its family, counting itself, has a Class I recall. 246 later devices descend from it.
- Decided
- Mar 2, 2007
- Review
- 121 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K962823 (1996). 14 ancestors in all, the oldest K792022 (1979). 246 later devices descend from it, 13 citing it directly. 1 of the 261 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 4 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 3 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 2 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 1 generation backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- This deviceK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- Descendant · cites it directly · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 2 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · cites it directly · 48 of its ownK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
Showing 5 of 246 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 246 · See all- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · cites it directly161descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 2 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
- K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH · 2009 · cites it directly48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −4 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −3 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −2 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −1 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| 0 (this device) | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| +1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +2 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +1 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 13 | 0 |
| 2016 | 7 | 0 |
| 2017 | 17 | 0 |
| 2018 | 5 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 0 |
| 2021 | 19 | 1 |
| 2022 | 21 | 0 |
| 2023 | 23 | 0 |
| 2024 | 28 | 0 |
| 2025 | 27 | 0 |
| 2026 | 36 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K060071 | Nexa Compression ScrewSummary page 1…his device is based on similarities in intended use, material, design and operational principle to the Nexa Compression Pin cleared under K060071, the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthe… | 2006 |
| * | K043102 | Multi-Use Compression ScrewSummary page 1…se, material, design and operational principle to the Nexa Compression Pin cleared under K060071, the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K0141 54… | 2005 |
| * | K792022 | Herbert Bone ScrewSummary page 1…ciple to the Nexa Compression Pin cleared under K060071, the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K0141 54) and the OsteoMed Super Screw System (K954330).… | 1979 |
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 1…the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K0141 54) and the OsteoMed Super Screw System (K954330). Due to the similarity of materials and design to both pre-enactm… | 2002 |
| * | K954330 | Super Screw 3.5 MMSummary page 1…2), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K0141 54) and the OsteoMed Super Screw System (K954330). Due to the similarity of materials and design to both pre-enactment and post- enactment device… | 1995 |
What descends from it? (246)
See all 24613 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111994 | Smith & Nephew Cannulated Screws and Washers | 2011 | 161 |
| K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | 2009 | 48 |
| K120493 | Mini Cannulated Headed and Headless Screw Set | 2012 | 39 |
| K110658 | Aptus Cannulated Compression Screws | 2011 | 12 |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | 2020 | 7 |
| K153338 | Tiger Cannulated Screw System | 2016 | 7 |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw System | 2017 | 3 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | 2023 | 1 |
| K170038 | FuzeFix Screw System | 2017 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K111994 (Smith & Nephew, Inc., 2011) has gone furthest, with 161 descendants of its own.
- 1 other device also cites its predicate K060071.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Osteomed Headless Cannulated Screw 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. Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063298 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063298: Osteomed Headless Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063298
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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