510(k) · Cleared
ClearedCannulated Fasteners and Nuts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OsteoCentric Technologies · HWC Screw, Fixation, Bone
Cleared on Apr 14, 2021 as substantially equivalent to K170021 (Smv Scientific, 2017) and 5 other predicates after a 30-day review. Its family tree reaches back 12 generations to 1996. 3 later devices descend from it.
- Decided
- Apr 14, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K962616 (1996). 114 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK150981 SMV Scientific Bone ScrewsSmv Scientific · 2015
- This deviceK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · cites it directly · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 2 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
- Descendant · 2 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK150981 SMV Scientific Bone ScrewsSmv Scientific · 2015
- This deviceK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
Most influential descendants
Showing 3 of 3 · See all- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · cites it directly2descendants
- K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 2 generations on0descendants
- K230226Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −1 | K150981 | SMV Scientific Bone Screws | Smv Scientific | 2015 | — |
| 0 (this device) | K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +1 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +2 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
| +2 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (6)
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 |
|---|---|---|---|
| * | K170021 | SMV Scientific Cannulated ScrewsSummary page 5…mber Trade or Proprietary or Model Manufacturer Predicate Name Type K170021 SMV Scientific Cannulated Bone SMV Scientific Primary Screws K202680… | 2017 |
| * | K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemSummary page 5…Type K170021 SMV Scientific Cannulated Bone SMV Scientific Primary Screws K202680 ExtremiFix Mini & Small OsteoMed LLC Additional Cannulated Screw System… | 2020 |
| * | K191344 | Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleSummary page 5…y Screws K202680 ExtremiFix Mini & Small OsteoMed LLC Additional Cannulated Screw System K191344 Arthrex Mini Comprehensive Arthrex Inc. Additional Fixation System - 2.0mm… | 2019 |
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 5…44 Arthrex Mini Comprehensive Arthrex Inc. Additional Fixation System - 2.0mm & 2.4mm Module K000080 Asnis III Cannulated Screw System Howmedica Additional… | 2000 |
| * | K081813 | Universal Compression Fracture Repair SystemSummary page 5…e K000080 Asnis III Cannulated Screw System Howmedica Additional Osteonics Corp. K081813 CompresSURE Fracture Repair U.S. Implant Additional System… | 2009 |
| * | K150981 | SMV Scientific Bone ScrewsSummary page 5…p. K081813 CompresSURE Fracture Repair U.S. Implant Additional System Solutions, LLC K150981 SMV Scientific Bone Screws SMV Scientific Additional PERFORMANCE TESTING SUMMARY In support of thi… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211290 | Cannulated Fasteners and Nuts | 2021 | 2 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 19 of the 114 ancestors have a recall of any class.
- Of its descendants, K211290 (OsteoCentric Technologies, 2021) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K170021.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital…
Read the full statement (170 words)
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and
non-unions of small bones and small bone arthrodesis. Examples include, but are not
limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions,
osteotomies, and bunionectomies.
The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for
fracture fixation of large bones and large bone fragments, femoral neck fractures,
slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures,
tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures,
intercondylar femur fractures, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation
where fracture compression is desired, and where insertion of the nut-and-bolt system
does not increase the risk of morbidity due to the need for surgical access to both
sides of the compressed area. The device may also be used when compression
between separate bones is desired (i.e.- the syndesmosis) as long as there is not
increased morbidity associated with the insertion of a nut-and-bolt system, as
discussed above.
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/K210754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210754: Cannulated Fasteners and Nuts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210754
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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