510(k) · Cleared
ClearedRayhack Osteotomy System (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creative Medical Designs, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 13, 1995 after a 196-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Dec 13, 1995
- Review
- 196 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK952766 Rayhack Osteotomy System (Modification)Creative Medical Designs, Inc. · 1995
- Descendant · cites it directly · 11 of its ownK043263 Trimed Osteotomy PlateTriMed, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 5 of its ownK141232 Aptus Ulna Shortening 2.5Medartis AG · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 3 generations on · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK130008 Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol)…I.T.S. GmbH · 2013 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K043263Trimed Osteotomy PlateTriMed, Inc. · 2005 · cites it directly11descendants
- K141232Aptus Ulna Shortening 2.5Medartis AG · 2014 · 2 generations on5descendants
- K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · 3 generations on1descendant
- K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · 3 generations on1descendant
- K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952766 | Rayhack Osteotomy System (Modification) | Creative Medical Designs, Inc. | 1995 | — |
| +1 | K043263 | Trimed Osteotomy Plate | TriMed, Inc. | 2005 | 1 |
| +2 | K141232 | Aptus Ulna Shortening 2.5 | Medartis AG | 2014 | 1 |
| +3 | K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +3 | K211592 | Avanti Orthopaedics Ulnar Shortening System | Avanti Orthopaedics, Inc. | 2021 | — |
| +2 | K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0… | I.T.S. GmbH | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K043263 (TriMed, Inc., 2005) has gone furthest, with 11 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.
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 | — |
https://510kreport.com/device/K952766 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952766: Rayhack Osteotomy System (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952766
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026