510(k) · Cleared
Recalled · Class II · 2020Titan Tibial Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 15, 2000 after a 79-day review. The FDA summary names no predicate by number. 79 later devices descend from it. It has been recalled 22 times.
- Decided
- Dec 15, 2000
- Review
- 79 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 22
- Predicates
- 0
79 later devices descend from it, 13 citing it directly.
- This deviceK003018 Titan Tibial NailHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · cites it directly · 17 of its ownK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- Descendant · cites it directly · 17 of its ownK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
- Descendant · cites it directly · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · cites it directly · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · cites it directly17descendants
- K131365T2 Tibial Nailing SystemStryker Trauma AG · 2013 · cites it directly17descendants
- K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · cites it directly17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · cites it directly16descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003018 | Titan Tibial Nail | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +1 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| +1 | K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | 2012 | 3 |
| +1 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +1 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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?
The FDA summary names no predicate by number.
What descends from it? (79)
See all 7913 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | 2018 | 17 |
| K131365 | T2 Tibial Nailing System | 2013 | 17 |
| K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | 2012 | 17 |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws… | 2018 | 16 |
| K102369 | Piccolo Composite Nailing System | 2011 | 16 |
| K111056 | Piccolo Composite Nailing System | 2011 | 15 |
| K011622 | Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2… | 2001 | 12 |
| K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon… | 2020 | 11 |
| K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail | 2014 | 10 |
| K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2020 | Class II | Z-2383-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2380-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2375-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| May 7, 2020 | Class II | Z-2374-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| Apr 27, 2018 | Class II | Z-2399-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2408-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2402-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2400-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2404-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2397-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2405-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2407-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2395-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2406-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2403-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2398-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2393-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2396-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2401-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Apr 27, 2018 | Class II | Z-2394-2018 | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Sep 27, 2007 | Not classified | Z-0214-2008 | Packaging process control | Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws. |
| Aug 4, 2003 | Not classified | Z-1295-03 | Other | The device does not have an oblong hole for dynamic locking as required. |
The 5 latest of 22 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172774 (Stryker Trauma GmbH, 2018) has gone furthest, with 17 descendants of its own.
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.
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 Titan Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The Titan Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
» Open and closed tibial fractures
« Pseudoarthrosis and correction osteotomy
« Pathologic fractures, impending pathologic fractures, and tumor resections
« Nonunion and malunion
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/K003018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003018: Titan Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003018
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026