510(k) · Cleared
Recalled · 2010Modular Foot System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HRS Plate, Fixation, Bone
Cleared on Mar 20, 2008 as substantially equivalent to K061808 (Darco International, Inc., 2006) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 1996. 342 later devices descend from it. It has been recalled once.
- Decided
- Mar 20, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954385 (1996). 22 ancestors in all, the oldest K920738 (1992). 342 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 4 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 3 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 2 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 1 generation backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- This deviceK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008
- Descendant · cites it directly · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · cites it directly · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · cites it directly · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
Showing 5 of 342 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 342 · See all- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · cites it directly339descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · cites it directly228descendants
- K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · cites it directly119descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 2 generations on118descendants
- K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −5 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −4 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −3 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −2 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −1 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| 0 (this device) | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | — |
| +1 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +1 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| +2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 14 | 0 |
| 2013 | 5 | 0 |
| 2014 | 13 | 0 |
| 2015 | 24 | 0 |
| 2016 | 13 | 0 |
| 2017 | 29 | 0 |
| 2018 | 15 | 0 |
| 2019 | 19 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 24 | 0 |
| 2023 | 28 | 0 |
| 2024 | 39 | 0 |
| 2025 | 24 | 0 |
| 2026 | 38 | 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? (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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…oot System Common or Usual Name Fixation Plates and Screws Classification Name Plate, Fixation, Bone Predicate Devices Darco Locking Bone Plate System (K061808) OrthoHelix MaxLock Small Bone System (K050868) Intended Use The Modular Foot System is indicated for fractures, fusions a… | 2006 |
| * | K050868 | MaxlockSummary page 1…ates and Screws Classification Name Plate, Fixation, Bone Predicate Devices Darco Locking Bone Plate System (K061808) OrthoHelix MaxLock Small Bone System (K050868) Intended Use The Modular Foot System is indicated for fractures, fusions and osteotomies of the hand, wrist, foot and ankl… | 2005 |
What descends from it? (342)
See all 3425 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | 2010 | 339 |
| K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | 2010 | 228 |
| K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | 2010 | 119 |
| K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | 2012 | 97 |
| K101962 | Mini Maxlock Extreme Plating System | 2010 | 85 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2010 | Not classified | Z-1784-2010 | Employee error | On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K100618 (Orthohelix Surgical Designs, Inc., 2010) has gone furthest, with 339 descendants of its own.
- 23 other devices also cite its predicate K061808.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073624 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073624: Modular Foot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073624
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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