510(k) · Cleared
ClearedFine Osteotomy™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodycad Laboratories, Inc. · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Jun 2, 2023 as substantially equivalent to K211646 (Bodycad Laboratories, Inc., 2021) after a 28-day review. Its family tree reaches back 17 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 2, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K954385 (1996). 286 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
- 2 generations backK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- 1 generation backK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
- This deviceK231314 Fine Osteotomy™Bodycad Laboratories, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK240066 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK240703 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
Show all 17 generations
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 15 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 14 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 13 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 12 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 11 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 10 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 9 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 8 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 7 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 4 generations backK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- 3 generations backK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
- 2 generations backK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- 1 generation backK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
- This deviceK231314 Fine Osteotomy™Bodycad Laboratories, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −17 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −16 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −15 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −14 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −13 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −12 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −11 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −10 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −9 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −8 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −7 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −4 | K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017 | — |
| −3 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
| −2 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | — |
| −1 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | — |
| 0 (this device) | K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023 | — |
| +1 | K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
| +2 | K240703 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 15 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 16 | 0 |
| 2001 | 19 | 0 |
| 2002 | 22 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 19 | 0 |
| 2006 | 17 | 0 |
| 2007 | 12 | 0 |
| 2008 | 19 | 0 |
| 2009 | 16 | 0 |
| 2010 | 17 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 PBF? 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 PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 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.
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 |
|---|---|---|---|
| K240066 | Fine Osteotomy™ | 2024 | 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 27 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 57 of the 286 ancestors have a recall of any class.
- Of its descendants, K240066 (Bodycad Laboratories, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PBF devicesPBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine Osteotomy™ is a patient-specific device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231314: Fine Osteotomy™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231314
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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