510(k) · Cleared
ClearedOrthohelix Syndesmosis Fixation Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HTN Washer, Bolt Nut
Cleared on Jan 3, 2014 as substantially equivalent to K123203 (Orthohelix Surgical Designs, Inc., 2012) and 4 other predicates after a 122-day review. Its family tree reaches back 12 generations to 1996. 3 later devices descend from it.
- Decided
- Jan 3, 2014
- Review
- 122 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K954385 (1996). 101 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- This deviceK132733 Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK141264 Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK143092 Tensyn PlugDallen Medical, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK150359 Tensyn PlugDallen Medical, Inc. · 2015
Show all 12 generations
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 10 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 9 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 8 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 7 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 6 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 5 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 4 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 3 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- This deviceK132733 Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −11 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −10 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −9 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −8 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −7 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −6 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −4 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −3 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −1 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| 0 (this device) | K132733 | Orthohelix Syndesmosis Fixation Devices | Orthohelix Surgical Designs, Inc. | 2014 | — |
| +1 | K141264 | Tensyn Band, Tensyn Fracture Plates | Dallen Medical, Inc. | 2014 | — |
| +2 | K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
| +3 | K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 11 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 11 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K123203 | Maxlock Extreme System Model MXLSummary page 1…Equivalence: The new OrtholelixTM Syndesmosis Fixation Devices are substantially equivalent to thle Orthol-elix MaxLock ExtremeT.M Systemn (K 123203). the Teleflex Force Fiber® Polyethylene Non- Absorbable Surgical Suture (K063i78). the Arthrex TightR… | 2012 |
| * | K063778 | Force Fiber Polyethylene Nonabsorbable Suture Our reading of the summary gave K063178, FDA’s number for Bard Collamend Implant, Models 1175102, 1175103, 1175104… (C.R. Bard, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Suture”. | 2007 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…emn (K 123203). the Teleflex Force Fiber® Polyethylene Non- Absorbable Surgical Suture (K063i78). the Arthrex TightRope"'l Syndesmosis Device (K043248). the Anthrex TigtRoperMI Acromnioclavicular (AC) Device (K052776). and the Biomet… | 2005 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 1…able Surgical Suture (K063i78). the Arthrex TightRope"'l Syndesmosis Device (K043248). the Anthrex TigtRoperMI Acromnioclavicular (AC) Device (K052776). and the Biomet ToggleLoclh System (1(083070). 'The indications of the Orthol-telix Syndlesmosis Fixa… | 2005 |
| * | K083070 | Toggleloc SystemSummary page 1…e (K043248). the Anthrex TigtRoperMI Acromnioclavicular (AC) Device (K052776). and the Biomet ToggleLoclh System (1(083070). 'The indications of the Orthol-telix Syndlesmosis Fixation D~evices diflb'r from sonic of the predic… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141264 | Tensyn Band, Tensyn Fracture Plates | 2014 | 2 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 18 of the 101 ancestors have a recall of any class.
- Of its descendants, K141264 (Dallen Medical, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K123203.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The OrthoHelix Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132733: Orthohelix Syndesmosis Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132733
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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