510(k) · Cleared
ClearedAdvanced Bone Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Double Medical Technology, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 25, 2023 as substantially equivalent to K141527 (Synthes USA, 2015) and 11 other predicates after a 280-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Jan 25, 2023
- Review
- 280 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 13 generations to K954385 (1996). 183 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- 2 generations backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- This deviceK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 11 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 10 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 9 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 8 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 7 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 6 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 5 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 4 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 3 generations backK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- 2 generations backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- This deviceK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −13 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −12 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −11 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −10 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −9 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −8 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −7 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −6 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −5 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −4 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −3 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| −2 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +1 | 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 | 2 | 0 |
| 1996 | 8 | 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 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 16 | 0 |
| 2010 | 10 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
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 |
|---|---|---|---|
| * | K141527 | Depuy Synthes Variable Angle Locking Hand SystemSummary page 5…K221150 - 510(k) Summary Primary predicate device: K141527 DePuy Synthes Variable Angle Locking Hand System Additional predic… | 2015 |
| * | K103243 | 2.4MM VA-LCP Intercarpal Fusion SystemSummary page 5…y Synthes Variable Angle Locking Hand System Additional predicate devices: K103243 Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion System K152974 Wrig… | 2011 |
| * | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction SystemSummary page 5…ate devices: K103243 Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion System K152974 Wright ORTHOLOC®3Di Foot Reconstruction System Legally marketed K090692 Wright ORT… | 2015 |
| * | K090692 | Ortholoc 2.0/2.4 Plate SystemSummary page 5…System K152974 Wright ORTHOLOC®3Di Foot Reconstruction System Legally marketed K090692 Wright ORTHOLOC® 2.0/ 2.4 Plate System device(s) to which K171852 Wright DARCOTM Locking Bone Pla… | 2009 |
| * | K171852 | DARCO Locking Bone Plate SystemSummary page 5…System Legally marketed K090692 Wright ORTHOLOC® 2.0/ 2.4 Plate System device(s) to which K171852 Wright DARCOTM Locking Bone Plate System equivalence is claimed K142121 Wright ORTHOLOC® Calcanea… | 2017 |
| * | K142121 | Valor Hindfoot Fusion Nail SystemSummary page 5…4 Plate System device(s) to which K171852 Wright DARCOTM Locking Bone Plate System equivalence is claimed K142121 Wright ORTHOLOC® Calcaneal Plating System K130108 Double Engine Bone Plate and Bone Screw System… | 2014 |
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 5…ARCOTM Locking Bone Plate System equivalence is claimed K142121 Wright ORTHOLOC® Calcaneal Plating System K130108 Double Engine Bone Plate and Bone Screw System K141383 Acumed Hand Plating System… | 2013 |
| * | K141383 | Acumed Hand Fracture SystemSummary page 5…K142121 Wright ORTHOLOC® Calcaneal Plating System K130108 Double Engine Bone Plate and Bone Screw System K141383 Acumed Hand Plating System K151277 NOVASTEP Airlock® osteosynthesis plate system… | 2014 |
| * | K151277 | Airlock® osteosynthesis plate systemSummary page 5…K130108 Double Engine Bone Plate and Bone Screw System K141383 Acumed Hand Plating System K151277 NOVASTEP Airlock® osteosynthesis plate system K222194 Baby Gorilla®/Gorilla® Plating System… | 2015 |
| * | K222194 | Baby Gorilla®/Gorilla® Plating System Cleared while this submission was under review Summary page 5…K141383 Acumed Hand Plating System K151277 NOVASTEP Airlock® osteosynthesis plate system K222194 Baby Gorilla®/Gorilla® Plating System K132898 Biomet A.L.P.S. Calcaneal Plating System… | 2022 |
| * | K132898 | A.L.P.S. Calcaneal Plating SystemSummary page 5…K151277 NOVASTEP Airlock® osteosynthesis plate system K222194 Baby Gorilla®/Gorilla® Plating System K132898 Biomet A.L.P.S. Calcaneal Plating System K132886 Smith&Nephew Variable- Angle Locking Reason for… | 2013 |
| * | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSummary page 5…K222194 Baby Gorilla®/Gorilla® Plating System K132898 Biomet A.L.P.S. Calcaneal Plating System K132886 Smith&Nephew Variable- Angle Locking Reason for 510(k) submission New device(Implant) 4. Device Description… | 2014 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 40 of the 183 ancestors have a recall of any class.
- Of its descendants, K242348 (Double Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K141527.
How does its category compare?
All HRS devicesHRS Plate, 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 · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is indicated for internal fixation. Specific indications for the plates included in the system as follows: The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is indicated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of…
Read the full statement (173 words)
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is indicated for internal fixation. Specific indications for the plates included in the system as follows:
The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is indicated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.
The ITVAL Foot & Ankle VAL System is indicated for internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.
The Distal Fibular VAL Plate is indicated for internal fixation (fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221150: Advanced Bone Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221150
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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