510(k) · Cleared
Recalled · Class II · 2023Ortholoc 3DI Hallux System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on May 3, 2012 as substantially equivalent to K061808 (Darco International, Inc., 2006) after an 87-day review. Its family tree reaches back 2 generations to 2002. 84 later devices descend from it. It has been recalled 2 times.
- Decided
- May 3, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022325 (2002). 84 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
- 1 generation backK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
- This deviceK120359 Ortholoc 3DI Hallux SystemWrightmedicaltechnologyinc · 2012
- Descendant · cites it directly · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · cites it directly · 24 of its ownK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- Descendant · 2 generations on · 23 of its ownK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · cites it directly31descendants
- K143025Total Compression Plating SystemWrightmedicaltechnologyinc · 2014 · cites it directly24descendants
- K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015 · 2 generations on23descendants
- K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · cites it directly22descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022325 | Normed Titanium Osteotomy Plating System | Osteomedics, Inc. | 2002 | 1 |
| −1 | K061808 | Darco Locking Bone Plate System | Darco International, Inc. | 2006 | 3 |
| 0 (this device) | K120359 | Ortholoc 3DI Hallux System | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +1 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| +2 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 8 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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? (1)
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…d Reference: 21 CFR 888.3030 - Class II Device Product Code, Device Panel: HIRS: Orthopedic (a)(3). Predicate Device: K06 1808 - DARCO Locking Bone Plate System (a)(4). Device Description Wright Medi… | 2006 |
| † | K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw | 2010 |
What descends from it? (84)
See all 8411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140397 | Paralock Plating System / Tuffnek Screw | 2014 | 31 |
| K143025 | Total Compression Plating System | 2014 | 24 |
| K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | 2015 | 22 |
| K162674 | BioPro Foot Plating Systems | 2017 | 19 |
| K143717 | Treace Medical Concepts (TMC) Plating System | 2015 | 12 |
| K151235 | Medline Foot Plates and Screws | 2015 | 10 |
| K171510 | Footmotion Plating System | 2017 | 1 |
| K200062 | Foot and Ankle System | 2021 | 0 |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | 2021 | 0 |
| K182785 | LOQTEQ VA Foot Plates 2.5 | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2023 | Class II | Z-1467-2023 | Employee error | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. |
| Apr 10, 2023 | Class II | Z-1466-2023 | Employee error | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K140397 (Paragon 28, 2014) has gone furthest, with 31 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. 2012, 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 ORTHOLOCm 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures; revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: * First metatarsal osteotomies for hallux valgus correction including: o Opening base wedge osteotomy o Closing base wedge osteotomy o Crescentic osteotorny o Proximal Chevron osteotomy o Distal Chevron osteotomy (Austin) * First metatarsal…
Read the full statement (109 words)
The ORTHOLOCm 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures; revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:
* First metatarsal osteotomies for hallux valgus correction including:
o Opening base wedge osteotomy
o Closing base wedge osteotomy
o Crescentic osteotorny
o Proximal Chevron osteotomy
o Distal Chevron osteotomy (Austin)
* First metatarsal fracture fixation
* Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
* Arthrodesis of the first metatarsophalangeal joint (MTP) including:
o .Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
o Revision MTP Fusion
o Revision of failed first MTP Arthropiasty implant
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120359: Ortholoc 3DI Hallux System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120359
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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