510(k) · Cleared
ClearedLocking Screw,CoCrMo
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 4, 2024 as substantially equivalent to K220921 (Double Medical Technology, Inc., 2022) and 3 other predicates after a 118-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Dec 4, 2024
- Review
- 118 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K954385 (1996). 191 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- This deviceK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 12 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 11 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 10 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 9 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 8 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 7 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 6 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 5 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 4 generations backK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- 3 generations backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- This deviceK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −13 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −12 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −11 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −10 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −9 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −8 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −7 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −6 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −5 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −4 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| −3 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
| −2 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| 0 (this device) | K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 14 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 12 | 0 |
| 2006 | 12 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 16 | 0 |
| 2010 | 10 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K220921 | Metal Bone ScrewSummary page 5…II Classification panel Orthopedic 3. Predicate Device Primary predicate device: K220921 Double Medical Metal Bone Screw Legally marketed Additional predicate device: device(s) to which K22… | 2022 |
| * | K221088 | Anatomic Bone PlateSummary page 5…e: K220921 Double Medical Metal Bone Screw Legally marketed Additional predicate device: device(s) to which K221088 Double Medical Anatomic Bone Plate equivalence is claimed K130108 Double Engine Bone Plate and Bo… | 2023 |
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 5…Additional predicate device: device(s) to which K221088 Double Medical Anatomic Bone Plate equivalence is claimed K130108 Double Engine Bone Plate and Bone Screw Systems K221150 Advanced Bone Plate Reason for 510(k)… | 2013 |
| * | K221150 | Advanced Bone PlateSummary page 5…edical Anatomic Bone Plate equivalence is claimed K130108 Double Engine Bone Plate and Bone Screw Systems K221150 Advanced Bone Plate Reason for 510(k) New device(Implant) submission 4. Device Description Loc… | 2023 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 40 of the 191 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
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/K242348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242348: Locking Screw,CoCrMo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242348
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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