510(k) · Cleared
ClearedAffixus Tibial Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 10, 2015 as substantially equivalent to K063570 (Biomet Manufacturing Corp, 2007) and 2 other predicates after a 70-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 10, 2015
- Review
- 70 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951740 (1995). 17 ancestors in all, the oldest K914453 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 1 generation backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK150867 Affixus Tibial Nailing SystemBiomet, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
- Descendant · 2 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
- Descendant · 3 generations on · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
Most influential descendants
Showing 3 of 3 · See all- K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · cites it directly2descendants
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 2 generations on1descendant
- K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −3 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −1 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K150867 | Affixus Tibial Nailing System | Biomet, Inc. | 2015 | — |
| +1 | K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023 | — |
| +2 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
| +3 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K063570 | Biomet Tibial Locking Nail SystemSummary page 4…ES (21 CFR 888.3020) Legally marketed devices to which substantial equivalence is claimed: x Biomet Phoenix Tibial Locking Nail System [K063570] x VersaNail Tibial Nail [K032097] x TriGen Meta-Nail Tibial Nails [K061019] Device Description The new Affixus Tibial Nai… | 2007 |
| * | K032097 | Depuy Ace Versanail Tibial NailSummary page 4…CFR 888.3020) Legally marketed devices to which substantial equivalence is claimed: x Biomet Phoenix Tibial Locking Nail System [K063570] x VersaNail Tibial Nail [K032097] x TriGen Meta-Nail Tibial Nails [K061019] Device Description The new Affixus Tibial Nailing System is part of a long bone na… | 2003 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 4…ich substantial equivalence is claimed: x Biomet Phoenix Tibial Locking Nail System [K063570] x VersaNail Tibial Nail [K032097] x TriGen Meta-Nail Tibial Nails [K061019] Device Description The new Affixus Tibial Nailing System is part of a long bone nailing system that offers an implant design to… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231266 | Pediatric Nailing Platform Tibia | 2023 | 2 |
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 3 companies; a new generation was cleared every 8.1 years on median.
- 8 of the 17 ancestors have a recall of any class.
- Of its descendants, K231266 (OrthoPediatrics Corp., 2023) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K063570.
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. 2015, 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?
Indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and for arthrodesis. This includes transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, open fractures, pathologic fractures, metaphyseal fractures and fractures with bone loss, prophylactic fixation of impending fractures, pseudoarthrosis of the tibial shaft, bone transport, nonunions, malunions, and corrective osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150867: Affixus Tibial Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150867
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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