510(k) · Cleared
ClearedMaxtorque Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HWC Screw, Fixation, Bone
Cleared on May 31, 2013 as substantially equivalent to K082574 (Orthohelix Surgical Designs, Inc., 2008) and 5 other predicates after a 23-day review. Its family tree reaches back 10 generations to 1996. 2 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 23 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K962616 (1996). 72 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- This deviceK131324 Maxtorque Screw SystemOrthohelix Surgical Designs, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK182989 AURORA™ Screw SystemMiRus, LLC · 2018
- Descendant · cites it directly · 0 of its ownK150871 ForeFoot STP SystemTornier, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- This deviceK131324 Maxtorque Screw SystemOrthohelix Surgical Designs, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K131324 | Maxtorque Screw System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| +1 | K182989 | AURORA™ Screw System | MiRus, LLC | 2018 | — |
| +1 | K150871 | ForeFoot STP System | Tornier, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K082574 | Maxtorque Mini Cannulated Screw SystemSummary page 1…bstantial Equivalence: The new MaxTorque'- Screws are substantially equivalent to the existing Orthoketix MaxTorque' m Screw System (1<082574 & K060428), the Asnis Ill Cannulated Screw System (1<000080), the Asnis Ill Micro Cannulated Screw… | 2008 |
| * | K060428 | CSS Cannulated Screw SystemSummary page 1…Equivalence: The new MaxTorque'- Screws are substantially equivalent to the existing Orthoketix MaxTorque' m Screw System (1<082574 & K060428), the Asnis Ill Cannulated Screw System (1<000080), the Asnis Ill Micro Cannulated Screw… | 2006 |
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 1…to the existing Orthoketix MaxTorque' m Screw System (1<082574 & K060428), the Asnis Ill Cannulated Screw System (1<000080), the Asnis Ill Micro Cannulated Screw System (K071092), the Smith and Nephew Cannulated Screws and Wa… | 2000 |
| * | K071092 | Asnis Micro Cannulated ScrewSummary page 1…1<082574 & K060428), the Asnis Ill Cannulated Screw System (1<000080), the Asnis Ill Micro Cannulated Screw System (K071092), the Smith and Nephew Cannulated Screws and Washers System (K111994) and the Synthes Headless Compres… | 2007 |
| * | K111994 | Smith & Nephew Cannulated Screws and WashersSummary page 1…, the Asnis Ill Micro Cannulated Screw System (K071092), the Smith and Nephew Cannulated Screws and Washers System (K111994) and the Synthes Headless Compression Screw System (1<080943). The submission is a modification to the… | 2011 |
| * | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSummary page 1…mith and Nephew Cannulated Screws and Washers System (K111994) and the Synthes Headless Compression Screw System (1<080943). The submission is a modification to the MaxTorque' m Screw System to add additional screw styles and… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 72 ancestors have a recall of any class.
- Of its descendants, K182989 (MiRus, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082574.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The MaxTorque M Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following:
- Fractures of the tarsal and metatarsals
- Fractures of the olecranon, distal humerus
- Fractures of the radius and ulna
- Patellar fractures
- Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- Tarso-metatarsal and metatarsal-phalangeal Arthrodesis
- Metatarsal and Phalangeal osteotomies
- Osteochondritis dissecans
- Ligament fixation
- Other small fragment, cancellous bone fractures and osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131324: Maxtorque Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131324
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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