510(k) · Cleared
ClearedOsteomed Hand Plate and Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · HRS Plate, Fixation, Bone
Cleared on Jul 2, 2009 as substantially equivalent to K911936 (Osteomed Corp., 1991) and 4 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1996. 15 later devices descend from it.
- Decided
- Jul 2, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K954385 (1996). 12 ancestors in all, the oldest K911936 (1991). 15 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 2 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 1 generation backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- This deviceK090522 Osteomed Hand Plate and Screw Fixation SystemOsteomed LP · 2009
- Descendant · cites it directly · 7 of its ownK132769 Acumed Hand Plating SystemAcumed, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK141383 Acumed Hand Fracture SystemAcumed, LLC · 2014
- Descendant · 3 generations on · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · cites it directly · 2 of its ownK120015 Osteomed Wrist Plating SystemOsteomed LP · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K132769Acumed Hand Plating SystemAcumed, LLC · 2014 · cites it directly7descendants
- K141383Acumed Hand Fracture SystemAcumed, LLC · 2014 · 2 generations on6descendants
- K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · 3 generations on3descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 4 generations on2descendants
- K120015Osteomed Wrist Plating SystemOsteomed LP · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −2 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −1 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| 0 (this device) | K090522 | Osteomed Hand Plate and Screw Fixation System | Osteomed LP | 2009 | — |
| +1 | K132769 | Acumed Hand Plating System | Acumed, LLC | 2014 | — |
| +2 | K141383 | Acumed Hand Fracture System | Acumed, LLC | 2014 | — |
| +3 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
| +4 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +1 | K120015 | Osteomed Wrist Plating System | Osteomed LP | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K911936 | Osteomed SBF System (SBF)Summary page 1…d/or medical grade polymers. Equivalence for this system is based on similarities in intended use, material, design and operational principle to the OsteoMed M3 System (K91 1936/Addendum K924138/K030448), Synthes Modular Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K03… | 1991 |
| * | K924138 | Osteomed M3 System (SBF System)Summary page 1…polymers. Equivalence for this system is based on similarities in intended use, material, design and operational principle to the OsteoMed M3 System (K91 1936/Addendum K924138/K030448), Synthes Modular Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K030310), SBI Hand F… | 1993 |
| * | K030448 | Osteomed 2.0 Locking Plates and ScrewsSummary page 1…s. Equivalence for this system is based on similarities in intended use, material, design and operational principle to the OsteoMed M3 System (K91 1936/Addendum K924138/K030448), Synthes Modular Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K030310), SBI Hand Fixation… | 2003 |
| Kept off the family tree | K060349 | FDA’s K060349 is Proguide Needle Set Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 1…inciple to the OsteoMed M3 System (K91 1936/Addendum K924138/K030448), Synthes Modular Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K030310), SBI Hand Fixation System (K050462), and Stryker Small Bone Plating System (K06 1497). Furthermore, OsteoMed also notes that som… | 2003 |
| * | K050462 | Sbi Hand Fixation System (TM)Summary page 1…91 1936/Addendum K924138/K030448), Synthes Modular Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K030310), SBI Hand Fixation System (K050462), and Stryker Small Bone Plating System (K06 1497). Furthermore, OsteoMed also notes that some sections of this system could have… | 2005 |
| Kept off the family tree | K061497 | FDA’s K061497 is Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML Our reading of the summary gave K061497, FDA’s number for Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML (Excelsior Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Small Bone Plating System”. Kept off the family tree. Summary page 1…r Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K030310), SBI Hand Fixation System (K050462), and Stryker Small Bone Plating System (K06 1497). Furthermore, OsteoMed also notes that some sections of this system could have been letter to file based on the OsteoMed previou… | 2007 |
What descends from it? (15)
See all 154 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K132769 (Acumed, LLC, 2014) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K911936.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device.
The OsteoMed Hand Plating System implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090522: Osteomed Hand Plate and Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090522
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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