510(k) · Cleared
ClearedApex Tibial Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthoxel · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 20, 2017 as substantially equivalent to K063570 (Biomet Manufacturing Corp, 2007) and 2 other predicates after a 261-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Dec 20, 2017
- Review
- 261 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000684 (2000). 71 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK063460 Acumed Congruent Bone Plate SystemAcumed, LLC · 2006
- 2 generations backK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · Recalled
- 1 generation backK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- This deviceK170972 Apex Tibial Nailing SystemOrthoxel · 2017
- Descendant · cites it directly · 0 of its ownK252025 Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K063460 | Acumed Congruent Bone Plate System | Acumed, LLC | 2006 | — |
| −2 | K080184 | Distal Humeral Plates with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | 1 |
| −1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| 0 (this device) | K170972 | Apex Tibial Nailing System | Orthoxel | 2017 | — |
| +1 | K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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…HWC Device Class: II Predicate Devices The System is substantially equivalent to the Biomet Tibial Locking Nail System (K063570), the Zimmer Natural Nail (K082770), and L.T.S. IM Nail Systems CFN‐CTN‐CHN (K132945) based on similarities in intended use, tech… | 2007 |
| * | K082770 | Zimmer Natural Nail System Tibial NailSummary page 4…II Predicate Devices The System is substantially equivalent to the Biomet Tibial Locking Nail System (K063570), the Zimmer Natural Nail (K082770), and L.T.S. IM Nail Systems CFN‐CTN‐CHN (K132945) based on similarities in intended use, technological characteristics, and perf… | 2008 |
| * | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailSummary page 4…ces The System is substantially equivalent to the Biomet Tibial Locking Nail System (K063570), the Zimmer Natural Nail (K082770), and L.T.S. IM Nail Systems CFN‐CTN‐CHN (K132945) based on similarities in intended use, technological characteristics, and performance data.… | 2014 |
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 |
|---|---|---|---|
| K252025 | Active Intramedullary (AIM) Tibial Nail System | 2026 | 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 17 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 31 of the 71 ancestors have a recall of any class.
- Of its descendants, K252025 (Satori Orthopaedics, Inc., 2026) has gone furthest, with 0 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. 2017, 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 Apex Tibial Nailing system is intended for temporary fixation and stabilization of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:
* Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
* Fractures involving osteopenic or osteoporotic bone;
* Fractures with bone loss;
* Pseudoarthosis, nonunion, and malunion;
* Correction osteotomy;
* Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
* Reconstruction following tumour resection.
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/K170972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170972: Apex 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/K170972
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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