510(k) · Cleared
ClearedIntegra Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · HRS Plate, Fixation, Bone
Cleared on Mar 14, 2005 as substantially equivalent to K040860 (Integra LifeSciences Corporation, 2004) after a 14-day review. Its family tree reaches back 1 generation to 2004. 6 later devices descend from it.
- Decided
- Mar 14, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040860 (2004). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040860 Integra Bone Fixation SystemIntegra LifeSciences Corporation · 2004
- This deviceK050492 Integra Bone Fixation SystemIntegra Lifesciences Corp. · 2005
- Descendant · cites it directly · 5 of its ownK073342 Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 4 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008 · cites it directly5descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 2 generations on3descendants
- K170697GBR systemSurgident · 2018 · 3 generations on2descendants
- K222367Save GBRDentis Co., Ltd. · 2023 · 4 generations on0descendants
- K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040860 | Integra Bone Fixation System | Integra LifeSciences Corporation | 2004 | — |
| 0 (this device) | K050492 | Integra Bone Fixation System | Integra Lifesciences Corp. | 2005 | — |
| +1 | K073342 | Salvin Dental Specialties, Inc., Fixation Screw | Salvin Dental Specialties, Inc. | 2008 | — |
| +2 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +3 | K170697 | GBR system | Surgident | 2018 | — |
| +4 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +4 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K040860 | Integra Bone Fixation SystemSummary page 1…quivalent in function and intended use to the unmodified Integra Bone Fixation System which has been cleared to market under Premarket Notificaiton 5 10(k) K040860. Intended Use: The Integra Bone Fixation System is intended for use in internal fixation of small bones affected b… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073342 | Salvin Dental Specialties, Inc., Fixation Screw | 2008 | 5 |
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?
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 | — |
What is it indicated for?
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr Hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050492: Integra Bone 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/K050492
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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