510(k) · Cleared
ClearedRenovo Life Small Bone IM Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovo Life, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 7, 2016 as substantially equivalent to K043185 (Synthes (Usa), 2005) and 2 other predicates after a 188-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Nov 7, 2016
- Review
- 188 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960642 (1996). 13 ancestors in all, the oldest K913949 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 2 generations backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
- 1 generation backK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
- This deviceK161254 Renovo Life Small Bone IM Nail SystemRenovo Life, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −4 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −3 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −2 | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (Usa) | 2008 | — |
| −1 | K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 | — |
| 0 (this device) | K161254 | Renovo Life Small Bone IM Nail System | Renovo Life, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 4…operational principles and material composition when compared to the predicate devices. Predicate Devices: K043185 Synthes Cortex Screw K081452 Synthes Stainless Steel Elastic Intramedullary Nail System… | 2005 |
| * | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSummary page 4…omposition when compared to the predicate devices. Predicate Devices: K043185 Synthes Cortex Screw K081452 Synthes Stainless Steel Elastic Intramedullary Nail System K143276 Accumed Small Bone IM Nail Syst… | 2008 |
| * | K143276 | Acumed Small Bone IM Nail SystemSummary page 4… K043185 Synthes Cortex Screw K081452 Synthes Stainless Steel Elastic Intramedullary Nail System K143276 Accumed Small Bone IM Nail System K161254 - Page 2 of 2… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 19 other devices also cite its predicate K043185.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.
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/K161254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161254: Renovo Life Small Bone IM Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161254
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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