510(k) · Cleared
ClearedEvolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on Aug 19, 2011 as substantially equivalent to K102352 (Wrightmedicaltechnologyinc, 2010) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 2010. 2 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K100146 (2010). 3 ancestors in all, the oldest K983495 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK100146 Evolve Eps OrtholocWrightmedicaltechnologyinc · 2010
- 1 generation backK102352 Evolve Eps OrtholocWrightmedicaltechnologyinc · 2010
- This deviceK111432 Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone…Wrightmedicaltechnologyinc · 2011
- Descendant · cites it directly · 1 of its ownK181587 ORTHOLOC SPS Shoulder Plating SystemTornier, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK191711 ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −2 | K100146 | Evolve Eps Ortholoc | Wrightmedicaltechnologyinc | 2010 | — |
| −1 | K102352 | Evolve Eps Ortholoc | Wrightmedicaltechnologyinc | 2010 | — |
| 0 (this device) | K111432 | Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws | Wrightmedicaltechnologyinc | 2011 | — |
| +1 | K181587 | ORTHOLOC SPS Shoulder Plating System | Tornier, Inc. | 2018 | — |
| +2 | K191711 | ORTHOLOC™ SPS Shoulder Plating System | Tornier, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K102352 | Evolve Eps OrtholocSummary page 1…l-IWC: Screw, Fixation Bone 87 Orthopedics A.3. Predicate Device: K102352-EVOLVE® FPS ORTHOLOCTM System K983495- Synt… | 2010 |
| * | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120…Summary page 1…cs A.3. Predicate Device: K102352-EVOLVE® FPS ORTHOLOCTM System K983495- Syntec-Taichung Non-Sterile Bone Screw Implants A.3. Device Description The EVOLVE®… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181587 | ORTHOLOC SPS Shoulder Plating System | 2018 | 1 |
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 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K181587 (Tornier, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K102352.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Wright's EVOLVE® TRIAD TM Plating System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna.
The ORTHOLO CT Mini polyaxial locking screws are intended for use with Wright's plates manufactured from implant grade stainless steel that accept ORT-OL OC ,, Mini polyaxial locking screws.
The EVOLVE® TRIAD TM Bone Screws are indicated for use in bone reconstruction, osteotomy. arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device, including the clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111432: Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111432
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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