510(k) · Cleared
ClearedSkyOPS™ Orthopedic Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sky Surgical, LLC · HRS Plate, Fixation, Bone
Cleared on Dec 21, 2023 as substantially equivalent to K121437 (Orthohelix Surgical Designs, Inc., 2012) and 3 other predicates after an 85-day review. Its family tree reaches back 16 generations to 1996. 1 later device descends from it.
- Decided
- Dec 21, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K954385 (1996). 249 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 2 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 1 generation backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- This deviceK233154 SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK251732 Wrist Fracture SystemMet One Technologies, LLC · 2026
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 backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 7 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 6 generations backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- 5 generations backK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
- 4 generations backK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- 3 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 2 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 1 generation backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- This deviceK233154 SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K251732Wrist Fracture SystemMet One Technologies, LLC · 2026 · cites it directly0descendants
View 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 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −7 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −6 | K143717 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2015 | — |
| −5 | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | — |
| −4 | K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019 | — |
| −3 | K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020 | — |
| −2 | K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022 | — |
| −1 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| 0 (this device) | K233154 | SkyOPS™ Orthopedic Plate System | Sky Surgical, LLC | 2023 | — |
| +1 | K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 14 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 15 | 0 |
| 2001 | 20 | 0 |
| 2002 | 21 | 0 |
| 2003 | 10 | 0 |
| 2004 | 8 | 0 |
| 2005 | 17 | 0 |
| 2006 | 16 | 0 |
| 2007 | 10 | 0 |
| 2008 | 8 | 0 |
| 2009 | 12 | 0 |
| 2010 | 12 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K121437 | Mini Maxlock Extreme Plating SystemSummary page 4…threaded metallic bone fixation fastener Panel: Orthopedic Product Code: HRS (Primary), HWC Predicate Devices: K121437 Mini MaxLock Extreme Plating System (Primary) K170214 Additive Orthopaedics Locking Lattice Plate… | 2012 |
| * | K170214 | Additive Orthopaedics Locking Lattice PlateSummary page 4…Product Code: HRS (Primary), HWC Predicate Devices: K121437 Mini MaxLock Extreme Plating System (Primary) K170214 Additive Orthopaedics Locking Lattice Plate K010321 Modular Foot System – 2.7mm Module… | 2017 |
| * | K010321 | Modular Foot System - 2.7 MM ModuleSummary page 4…K121437 Mini MaxLock Extreme Plating System (Primary) K170214 Additive Orthopaedics Locking Lattice Plate K010321 Modular Foot System – 2.7mm Module K221181 TMC Plating System Device Description: The subject Sk… | 2001 |
| * | K221181 | Treace Medical Concepts (TMC) Plating SystemSummary page 4…K170214 Additive Orthopaedics Locking Lattice Plate K010321 Modular Foot System – 2.7mm Module K221181 TMC Plating System Device Description: The subject SkyOPS™ Orthopedic Plate System consists of various plates and screws that ar… | 2023 |
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 |
|---|---|---|---|
| K251732 | Wrist Fracture System | 2026 | 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 27 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 48 of the 249 ancestors have a recall of any class.
- Of its descendants, K251732 (Met One Technologies, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K121437.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 SkyOPS™ Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233154: SkyOPS™ Orthopedic Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233154
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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