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. · HRS Plate, Fixation, Bone
Cleared on Jul 28, 2021 as substantially equivalent to K193614 (Bodycad Laboratories, Inc., 2020) after a 61-day review. Its family tree reaches back 16 generations to 1996. 3 later devices descend from it.
- Decided
- Jul 28, 2021
- Review
- 61 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K954385 (1996). 285 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- 2 generations backK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
- 1 generation backK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- This deviceK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK231314 Fine Osteotomy™Bodycad Laboratories, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK240066 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK240703 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 14 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 13 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 12 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 11 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 10 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 9 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 8 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 7 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 6 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 3 generations backK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- 2 generations backK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
- 1 generation backK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- This deviceK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −15 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −14 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −13 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −12 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −11 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −10 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −9 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −8 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −7 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −6 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −3 | K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017 | — |
| −2 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
| −1 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | — |
| 0 (this device) | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | — |
| +1 | K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023 | — |
| +2 | K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
| +3 | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K193614 | FINE Osteotomy around the kneeSummary page 4…Regulation Numbers: Primary regulation, 21 CFR 888.3030. Additional regulation, 21 CFR 888.3040. C. PRIMARY PREDICATE DEVICE K193614 Bodycad Fine Osteotomy™… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231314 | Fine Osteotomy™ | 2023 | 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 25 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 57 of the 285 ancestors have a recall of any class.
- Of its descendants, K231314 (Bodycad Laboratories, Inc., 2023) has gone furthest, with 2 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. 2021, 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?
Fine Osteotomy M 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/K211646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211646: 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/K211646
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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