510(k) · Cleared
ClearedOsteomed Hand Fusion 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 Oct 7, 2011 as substantially equivalent to K063298 (Osteomed LP, 2007) and 3 other predicates after a 140-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Oct 7, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962823 (1996). 29 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- This deviceK111419 Osteomed Hand Fusion SystemOsteomed LP · 2011
- Descendant · cites it directly · 0 of its ownK130120 Extremity Medical IP Fusion SystemExtremity Medical, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| 0 (this device) | K111419 | Osteomed Hand Fusion System | Osteomed LP | 2011 | — |
| +1 | K130120 | Extremity Medical IP Fusion System | Extremity Medical, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 2…rgery and reconstructive procedure. The OsteoMed Hand Fusion System implants are intended for single use only. Substantial Equivalence Information: K063298 - OsteoMed Cannulated Headless Screw System K090522 - OsteoMed Hand Plating System K(063049 - Synthes Modular Mini Fr… | 2007 |
| * | K090522 | Osteomed Hand Plate and Screw Fixation SystemSummary page 2…on System implants are intended for single use only. Substantial Equivalence Information: K063298 - OsteoMed Cannulated Headless Screw System K090522 - OsteoMed Hand Plating System K(063049 - Synthes Modular Mini Fragment LCP System K(030310 - Synthes Stainless Steel… | 2009 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 2…only. Substantial Equivalence Information: K063298 - OsteoMed Cannulated Headless Screw System K090522 - OsteoMed Hand Plating System K(063049 - Synthes Modular Mini Fragment LCP System K(030310 - Synthes Stainless Steel Modular Hand System The OsteoMed Hand Fusion… | 2006 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 2…K063298 - OsteoMed Cannulated Headless Screw System K090522 - OsteoMed Hand Plating System K(063049 - Synthes Modular Mini Fragment LCP System K(030310 - Synthes Stainless Steel Modular Hand System The OsteoMed Hand Fusion System shares dimensional and material characteristics wi… | 2003 |
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 |
|---|---|---|---|
| K130120 | Extremity Medical IP Fusion System | 2013 | 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 15 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K130120 (Extremity Medical, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K063298.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure.
The OsteoMed Hand Fusion System implants are intended for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111419 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111419: Osteomed Hand Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111419
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