510(k) · Cleared
ClearedOrtholoc 3DI Midfoot/Flatfoot 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 Oct 12, 2012 as substantially equivalent to K061808 (Darco International, Inc., 2006) and 3 other predicates after a 129-day review. Its family tree reaches back 9 generations to 1996. 95 later devices descend from it.
- Decided
- Oct 12, 2012
- Review
- 129 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K954385 (1996). 49 ancestors in all, the oldest K895117 (1990). 95 later devices descend from it, 13 citing it directly.
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 2 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 1 generation backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- This deviceK121651 Ortholoc 3DI Midfoot/Flatfoot 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 · cites it directly · 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
Show all 9 generations
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 7 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 6 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 5 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 4 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 3 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 2 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 1 generation backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- This deviceK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · 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 · cites it directly23descendants
- 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 |
|---|---|---|---|---|---|
| −9 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −8 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −7 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −6 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −5 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −4 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −3 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −2 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −1 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| 0 (this device) | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +1 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 11 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…on Name: Bone Plate System Classification Name and Reference: 21 CFR 888.3030 - Class [I . Device Product Code, Device Panel: HRS: Orthopedic (a)(3). Predicate Device: K061808 - DARCO Locking Bone Plate System K113014 — CLAW Il Polyaxial Compression System K100618 — Orthohelix Variable Angle Plates K 1… | 2006 |
| * | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsSummary page 1…Name and Reference: 21 CFR 888.3030 - Class [I . Device Product Code, Device Panel: HRS: Orthopedic (a)(3). Predicate Device: K061808 - DARCO Locking Bone Plate System K113014 — CLAW Il Polyaxial Compression System K100618 — Orthohelix Variable Angle Plates K 100502 — Ascension Plating System K11663 —… | 2012 |
| * | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle TechnologySummary page 1…. Device Product Code, Device Panel: HRS: Orthopedic (a)(3). Predicate Device: K061808 - DARCO Locking Bone Plate System K113014 — CLAW Il Polyaxial Compression System K100618 — Orthohelix Variable Angle Plates K 100502 — Ascension Plating System K11663 — DePuy A.L.P.S. Total Foot System (a)(4). Device… | 2010 |
| * | K100502 | Ascension Total Plate SystemSummary page 1…thopedic (a)(3). Predicate Device: K061808 - DARCO Locking Bone Plate System K113014 — CLAW Il Polyaxial Compression System K100618 — Orthohelix Variable Angle Plates K 100502 — Ascension Plating System K11663 — DePuy A.L.P.S. Total Foot System (a)(4). Device Description Wright Medical’s ORTHOLOC™ 3Di… | 2010 |
| Kept off the family tree | K110663 | FDA’s K110663 is Pairetex Optimized Composite Mesh (Pco-FX Refrences) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| † | K120359 | Ortholoc 3DI Hallux System | 2012 |
What descends from it? (95)
See all 9513 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 |
| K151442 | Total Compression Plating (TCP) System | 2015 | 23 |
| 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 |
| K161448 | Footmotion Plating System | 2016 | 5 |
| K151407 | RECON system | 2015 | 4 |
| K140792 | Salvation 3DI Plating System | 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 16 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 12 of the 49 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 ORTHOLOC™ 3Di Midfoot/Flatfoot System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include:
Flatfoot Osteotomies
Lateral column Lengthening (Evans Osteotomy)
Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
Medial Displacement Calcaneal Osteotomy (MDCO)
Mid / Hindfoot Fusions
LisFranc Arthrodesis and/or Stabilization
1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121651: Ortholoc 3DI Midfoot/Flatfoot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121651
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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