510(k) · Cleared
ClearedMetal Cannulated Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Double Medical Technology, Inc. · HWC Screw, Fixation, Bone
Cleared on Jan 10, 2023 as substantially equivalent to K130108 (Xiamen Double Engine Medical Material Co., Ltd., 2013) and 5 other predicates after a 272-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Jan 10, 2023
- Review
- 272 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K962616 (1996). 167 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- 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 backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- This deviceK221090 Metal Cannulated ScrewDouble Medical Technology, Inc. · 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 backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- This deviceK221090 Metal Cannulated ScrewDouble Medical Technology, Inc. · 2023
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 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| 0 (this device) | K221090 | Metal Cannulated Screw | Double Medical Technology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 8 | 0 |
| 1996 | 16 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 16 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 5…tory class II Classification panel Orthopedic 3. Predicate Device Primary Predicate Device: K130108 Double Engine Bone Plate and Bone Screw Systems Additional Predicate Devices: Legally marketed… | 2013 |
| * | K143229 | Nexis osteosynthesis compressive screwsSummary page 5…K130108 Double Engine Bone Plate and Bone Screw Systems Additional Predicate Devices: Legally marketed K143229 Nexis® osteosynthesis compressive screws device(s) to which K161616 DePuy Synthes 4.0 mm/4.5 mm/6.5 mm/7.3 mm equivalen… | 2015 |
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Summary page 5…ems Additional Predicate Devices: Legally marketed K143229 Nexis® osteosynthesis compressive screws device(s) to which K161616 DePuy Synthes 4.0 mm/4.5 mm/6.5 mm/7.3 mm equivalence is claimed Cannulated Screws K182361 Art… | 2017 |
| * | K182361 | Arthrex Compression FT ScrewsSummary page 5…ressive screws device(s) to which K161616 DePuy Synthes 4.0 mm/4.5 mm/6.5 mm/7.3 mm equivalence is claimed Cannulated Screws K182361 Arthrex Compression FT Screws K170382 Arthrex Compression Screws K16235… | 2018 |
| * | K170382 | Arthrex Compression ScrewsSummary page 5….0 mm/4.5 mm/6.5 mm/7.3 mm equivalence is claimed Cannulated Screws K182361 Arthrex Compression FT Screws K170382 Arthrex Compression Screws K162353 MICATM Screw System Reason for 510(k)… | 2017 |
| * | K162353 | MICATM Screw SystemSummary page 5…ed Screws K182361 Arthrex Compression FT Screws K170382 Arthrex Compression Screws K162353 MICATM Screw System Reason for 510(k) New device (Implant) submission 4. Device Description Metal C… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 24 of the 167 ancestors have a recall of any class.
- 8 other devices also cite its predicate K130108.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot: 1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. 2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, radius, fibula, and small bones…
Read the full statement (436 words)
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis,
hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing and stabilizing the elective osteotomies of the mid
foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, radius, fibula, and
small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation
of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation
of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, and the bones of the
hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation
of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and
the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an
adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar
femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm) /Headless Compression Screw (2.5-4.5mm) are indicated for fixation of
fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also
indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of
fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone
reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges.
9)The 6.5mm Cannulated Screw are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of
long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral
neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures,
tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions
of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for
slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221090: Metal Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221090
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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