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 Aug 21, 2025 as substantially equivalent to K241356 (Bodycad Laboratories, Inc., 2024) after a 147-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Aug 21, 2025
- Review
- 147 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000682 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK000682 Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- 2 generations backK141796 Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC · 2014
- 1 generation backK241356 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
- This deviceK250923 Fine Osteotomy™Bodycad Laboratories, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253300 Fine Osteotomy™Bodycad Laboratories, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253300Fine Osteotomy™Bodycad Laboratories, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| −2 | K141796 | Depuy Synthes Tomofix Osteotomy System | Synthes (USA) Products, LLC | 2014 | — |
| −1 | K241356 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
| 0 (this device) | K250923 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2025 | — |
| +1 | K253300 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K241356 | Fine Osteotomy™Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K241356 11 Fine Osteotomy™ 11 HRS .-- Device Descri… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253300 | Fine Osteotomy™ | 2025 | 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 25 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K253300 (Bodycad Laboratories, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K241356.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 ™ 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/K250923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250923: 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/K250923
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