510(k) · Cleared
ClearedORTHOLOC® 3Di Foot Plating Reconstruction 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 Dec 11, 2015 as substantially equivalent to K151442 (Wrightmedicaltechnologyinc, 2015) and 3 other predicates after a 64-day review. Its family tree reaches back 12 generations to 1996. 22 later devices descend from it.
- Decided
- Dec 11, 2015
- Review
- 64 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K954385 (1996). 63 ancestors in all, the oldest K895117 (1990). 22 later devices descend from it, 7 citing it directly.
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 2 generations backK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- 1 generation backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- This deviceK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 2 generations on · 3 of its ownK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- Descendant · 3 generations on · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK233423 Tyber Medical Anatomical Plating System – Line extension to the…Tyber Medical, LLC · 2023
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 backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 3 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 2 generations backK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- 1 generation backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- This deviceK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · cites it directly10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 2 generations on9descendants
- K232652Anatomical Plating System (various)Tyber Medical, LLC · 2023 · 2 generations on3descendants
- K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · 3 generations on2descendants
- K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC · 2023 · 2 generations on2descendants
View 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 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −3 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −2 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +2 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +2 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| +3 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
| +2 | K233423 | Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System | Tyber Medical, LLC | 2023 | — |
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 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K151442 | Total Compression Plating (TCP) SystemSummary page 4…21 CFR 888.3030 – Class II Device Product Code, Device Panel: HR^ – Orthopedic (a)(3). Predicate Device: K151442: TOTAL COMPRESSION PLATING SYSTEM… | 2015 |
| * | K132594 | Crosscheck Plating SystemSummary page 4…K151442: TOTAL COMPRESSION PLATING SYSTEM K132594: CrossCHECK Plating System K120359: ORTHOLOC® 3Di Hallux System… | 2013 |
| * | K120359 | Ortholoc 3DI Hallux SystemSummary page 4…SYSTEM K132594: CrossCHECK Plating System K120359: ORTHOLOC® 3Di Hallux System K121651: ORTHOLOC® 3Di… | 2012 |
| * | K121651 | Ortholoc 3DI Midfoot/Flatfoot SystemSummary page 4…ssCHECK Plating System K120359: ORTHOLOC® 3Di Hallux System K121651: ORTHOLOC® 3Di Midfoot/Flatfoot System (a)(4). Device Descriptio… | 2012 |
What descends from it? (22)
See all 227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203817 | Tyber Medical Anatomical Plating System | 2021 | 10 |
| K221150 | Advanced Bone Plate | 2023 | 1 |
| K210060 | CoLink Mfx Implant System | 2021 | 1 |
| K202959 | PolyLock Plating System | 2020 | 1 |
| K192696 | TriMed ASET Foot Plating System | 2020 | 1 |
| K182015 | Piccolo Composite® Plate System | 2018 | 1 |
| K200062 | Foot and Ankle System | 2021 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 63 ancestors have a recall of any class.
- Of its descendants, K203817 (Tyber Medical, LLC, 2021) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Foot Plating Reconstruction 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: 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 •…
Read the full statement (163 words)
The ORTHOLOC® 3Di Foot Plating Reconstruction 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:
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
First metatarsal osteotomies for hallux valgus correction including:
• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant
Flatfoot Osteotomies
• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152974
Report an extraction error
Are you the manufacturer?
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