510(k) · Cleared
ClearedAUTOBAHN Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 29, 2017 as substantially equivalent to K040762 (Synthes (Usa), 2004) and 9 other predicates after a 259-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 29, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K951740 (1995). 39 ancestors in all, the oldest K871539 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 5 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 4 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 3 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- 2 generations backK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- 1 generation backK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- This deviceK171108 AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK220659 AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK261043 AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −5 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −4 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −3 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| −2 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| −1 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| 0 (this device) | K171108 | AUTOBAHN Nailing System | Globus Medical, Inc. | 2017 | — |
| +1 | K220659 | AUTOBAHN (R) EVO Femoral Nails | Globus Medical, Inc. | 2022 | — |
| +1 | K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (10)
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 |
|---|---|---|---|
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 5…HWC Regulatory Class: II, Panel Code: 87 Predicates: Nail Predicate Device Tibial Synthes Tibial Nail System EX (K040762)* T2 Tibial Nailing System (K131365) TriGen® Meta-Nail Retrograde F… | 2004 |
| * | K131365 | T2 Tibial Nailing SystemSummary page 5…tes: Nail Predicate Device Tibial Synthes Tibial Nail System EX (K040762)* T2 Tibial Nailing System (K131365) TriGen® Meta-Nail Retrograde Femoral & Tibial Nails (K061019)… | 2013 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 5…T2 Tibial Nailing System (K131365) TriGen® Meta-Nail Retrograde Femoral & Tibial Nails (K061019) Synthes Locking Screws (K000089) Trochanteric Gamma3® Nail System (K043431)*… | 2006 |
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 5…TriGen® Meta-Nail Retrograde Femoral & Tibial Nails (K061019) Synthes Locking Screws (K000089) Trochanteric Gamma3® Nail System (K043431)* Synthes Trochanteric Fixation Nail… | 2000 |
| * | K043431 | GAMMA3 Nail SystemSummary page 5…ial Nails (K061019) Synthes Locking Screws (K000089) Trochanteric Gamma3® Nail System (K043431)* Synthes Trochanteric Fixation Nail – Advanced System (K131548)… | 2005 |
| * | K131548 | Synthes Trochanteric Fixation Nail - Advanced SystemSummary page 5…Trochanteric Gamma3® Nail System (K043431)* Synthes Trochanteric Fixation Nail – Advanced System (K131548) A/R Femoral Zimmer Natural Nail System Retrograde Femoral Nails (K101622)*… | 2014 |
| * | K101622 | Zimmer Natural Nail System Retrograde Femoral NailsSummary page 5…d System (K131548) A/R Femoral Zimmer Natural Nail System Retrograde Femoral Nails (K101622)* Synthes Retrograde/Antegrade Femoral Nail System (K033618)… | 2010 |
| * | K033618 | Synthes (Usa) Retrograde/Antegrade Femoral Nail SystemSummary page 5…ral Nails (K101622)* Synthes Retrograde/Antegrade Femoral Nail System (K033618) Zimmer Natural Nail System Piriformis Fossa & Greater Trochante… | 2004 |
| * | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsSummary page 5…Zimmer Natural Nail System Piriformis Fossa & Greater Trochanter Antegrade Femoral Nails (K083497) T2 Femoral Nail (K112059) * Primary Predicates… | 2009 |
| * | K112059 | T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpSummary page 5…Greater Trochanter Antegrade Femoral Nails (K083497) T2 Femoral Nail (K112059) * Primary Predicates K1711… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 23 of the 39 ancestors have a recall of any class.
- Of its descendants, K220659 (Globus Medical, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K040762.
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 AUTOBAHN™ Tibial Nail is indicated for stabilization of fractures in skeletally mature patients, specifically fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre- and postisthmic fractures, non-unions, malunions, pseudarthrosis, corrective osteotomies, prophylactic nailing of impending pathological fractures, tumor resections, simple long bone fractures, severely comminuted, spiral…
Read the full statement (264 words)
The AUTOBAHN™ Tibial Nail is indicated for stabilization of fractures in skeletally mature patients, specifically fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre- and postisthmic fractures, non-unions, malunions, pseudarthrosis, corrective osteotomies, prophylactic nailing of impending pathological fractures, tumor resections, simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, polytrauma and multiple fractures, reconstruction, following tumor resection and grafting, supracondylar fractures, and bone lengthening and shortening.
The AUTOBAHN™ Trochanteric Nail is indicated for treatment of fractures in adults and adolescents (12-21 years of age) in which the growth plates have fused for the following indications: basal neck fractures, fixation of stable and unstable intertrochanteric, pertrochanteric, and subtrochanteric fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, combinations of pertrochanteric, intertrochanteric, basal neck fractures, long subtrochanteric fractures, tumor resections, fractures resulting from trauma, nonunions, malunions, and revision procedures.
AUTOBAHN™ Antegrade/Retrograde Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures, fractures involving femoral condyles, comminuted fractures, fractures with bone loss, and periprosthetic fractures.
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/K171108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171108: AUTOBAHN Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171108
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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