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 Aug 3, 2021 as substantially equivalent to K210754 (OsteoCentric Technologies, 2021) and 3 other predicates after a 97-day review. Its family tree reaches back 13 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 3, 2021
- Review
- 97 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K962616 (1996). 137 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 2 generations backK150981 SMV Scientific Bone ScrewsSmv Scientific · 2015
- 1 generation backK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- This deviceK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · cites it directly · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
- Descendant · cites it directly · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 3 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 2 generations backK150981 SMV Scientific Bone ScrewsSmv Scientific · 2015
- 1 generation backK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- This deviceK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −2 | K150981 | SMV Scientific Bone Screws | Smv Scientific | 2015 | — |
| −1 | K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| 0 (this device) | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +1 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
| +1 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 13 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K210754 | Cannulated Fasteners and NutsSummary page 5…oprietary or Model Manufacturer Predicate Name Type K210754 Cannulated Fasteners and Nuts OsteoCentric Technologies Primary K170021 SMV Scientific C… | 2021 |
| * | K170021 | SMV Scientific Cannulated ScrewsSummary page 5…Type K210754 Cannulated Fasteners and Nuts OsteoCentric Technologies Primary K170021 SMV Scientific Cannulated Screws SMV Scientific Additional K193214 Biomet Cannul… | 2017 |
| * | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Summary page 5…eners and Nuts OsteoCentric Technologies Primary K170021 SMV Scientific Cannulated Screws SMV Scientific Additional K193214 Biomet Cannulated Screw System Biomet Additional K190324 OrthoPediatri… | 2020 |
| * | K190324 | OrthoPediatrics Cannulated Screw SystemSummary page 5…nulated Screws SMV Scientific Additional K193214 Biomet Cannulated Screw System Biomet Additional K190324 OrthoPediatrics Cannulated Screw OrthoPediatrics Additional System PERFO… | 2019 |
What descends from it? (2)
2 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 25 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 137 ancestors have a recall of any class.
- Of its descendants, K242691 (OsteoCentric Technologies, 2024) has gone furthest, with 0 descendants of its own.
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 and 3.0mm Cannulated Screw are 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 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the…
Read the full statement (238 words)
The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are 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 3.5mm Cannulated Screws are intended for fixation of small bones and
small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and
phalanges, steochnondritis dissecans, and ligament fixation.
The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones
and long bone fragments.
The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of
long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped
capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in
basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck
fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and
iliosacral joints, 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 (e.g. 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 as stated in the FDA summary.
https://510kreport.com/device/K211290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211290: 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/K211290
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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