510(k) · Cleared
ClearedMetal Bone 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 Dec 12, 2022 as substantially equivalent to K130108 (Xiamen Double Engine Medical Material Co., Ltd., 2013) and 1 other predicate after a 257-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.
- Decided
- Dec 12, 2022
- Review
- 257 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K792022 (1979). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 3 generations backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- 2 generations backK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
- 1 generation backK143146 Nexis osteosynthesis snap-off screwsNovastep · 2015
- This deviceK220921 Metal Bone ScrewDouble Medical Technology, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242348Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −3 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| −2 | K070039 | Memometal Fixos Screws | Memometal Technologies | 2007 | — |
| −1 | K143146 | Nexis osteosynthesis snap-off screws | Novastep | 2015 | — |
| 0 (this device) | K220921 | Metal Bone Screw | Double Medical Technology, Inc. | 2022 | — |
| +1 | K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 4…II Classification panel Orthopedic 3. Predicate Device Primary predicate device: Legally marketed K130108 Double Engine Bone Plate and Bone Screw System device(s) to which Additional predicate device: eq… | 2013 |
| * | K143146 | Nexis osteosynthesis snap-off screwsSummary page 4…e Bone Plate and Bone Screw System device(s) to which Additional predicate device: equivalence is claimed K143146 Nexis® osteosynthesis snap-off screws Reason for 510(k) New device(Implant) submission 4. Device… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242348 | Locking Screw,CoCrMo | 2024 | 0 |
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 43 years and passes through 5 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K242348 (Double Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 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. 2022, 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 Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220921: Metal Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220921
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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