510(k) · Cleared
Recalled · Class II · 2020Revolution External Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Standard Device Dba Metalogix · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on May 29, 2019 as substantially equivalent to K071394 (Small Bone Innovations, Inc., 2007) and 6 other predicates after a 343-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it. It has been recalled 5 times.
- Decided
- May 29, 2019
- Review
- 343 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 5
- Predicates
- 7
Its longest line of descent runs back 13 generations to K962616 (1996). 66 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 2 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 1 generation backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- This deviceK181630 Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019
- Descendant · cites it directly · 0 of its ownK233025 Revolution External Plating SystemNew Standard Device Dba Metalogix · 2024
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 3 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 2 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 1 generation backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- This deviceK181630 Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019
Most influential descendants
Showing 1 of 1 · See all- K233025Revolution External Plating SystemNew Standard Device Dba Metalogix · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −3 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −2 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −1 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| 0 (this device) | K181630 | Revolution External Plating System | New Standard Device Dba Metalogix | 2019 | — |
| +1 | K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 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? (7)
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 |
|---|---|---|---|
| * | K071394 | Modification to:Sbi RingfixSummary page 5…Trade or Proprietary or Model Manufacturer Predicate Name Type K071394 SBi RingFIX™ System Small Bone Primary… | 2007 |
| * | K053472 | Hoffmann II Mri External Fixation SystemSummary page 5…071394 SBi RingFIX™ System Small Bone Primary Innovations K053472 Hoffmann® II MRI External Howmedical Secondary Fixation Syst… | 2006 |
| * | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Summary page 5…2 Hoffmann® II MRI External Howmedical Secondary Fixation System Osteonics Corp K152171 Orthofix TL-HEX True Lok Orthofix Srl Secondary Hexapod Syste… | 2015 |
| * | K970748 | Taylor Spatial Frame External Fixation SystemSummary page 5…Osteonics Corp K152171 Orthofix TL-HEX True Lok Orthofix Srl Secondary Hexapod System (TL-HEX) K970748 Taylor Spatial Frame External Smith & Secondary Fixation Syst… | 1997 |
| * | K112218 | Ace-Fischer (R), Tempfix (R), Hoffman Classic (TM) External FixatorsSummary page 5…0748 Taylor Spatial Frame External Smith & Secondary Fixation System Nephew Inc. K112218 Ace-Fischer® External Fixation DePuy Secondary System… | 2011 |
| * | K031181 | External Fixation SystemsSummary page 5…Secondary System Orthopaedics, Inc. K031181 External Fixation Systems Smith & Secondary… | 2003 |
| * | K140463 | Integra External Fixation SystemSummary page 5…181 External Fixation Systems Smith & Secondary Nephew, Inc. K140463 Integra External Fixation System Ascension Secondary… | 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 |
|---|---|---|---|
| K233025 | Revolution External Plating System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2020 | Class II | Z-1649-2022 | Device Design | Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. |
| Jun 8, 2020 | Class II | Z-1236-2022 | Device Design | 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage. |
| Oct 10, 2019 | Class II | Z-0318-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Aug 14, 2019 | Class II | Z-1280-2022 | Nonconforming Material/Component | Due to manufacturing processing error, wrench causing stripping when torqueing nuts. |
| Jul 23, 2019 | Class II | Z-1824-2023 | Under Investigation by firm | The threads on posts stripping out when tensioned during application process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 66 ancestors have a recall of any class.
- Of its descendants, K233025 (New Standard Device Dba Metalogix, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071394.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:
• Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
• Fusions of the joints and bone (hand, foot, long-bone)
• Correction of bone or soft tissue deformities
• Correction of segmental or non-segmental bone, soft tissue defects or bone loss
• Neutralization of fractures stabilized with limited internal fixation
• Adult and Pediatric subgroups except newborns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181630: Revolution External Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181630
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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