510(k) · Cleared
ClearedGPC Intramedullary Nailing Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gpc Medical Limited · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Sep 30, 2015 as substantially equivalent to K040762 (Synthes (Usa), 2004) and 1 other predicate after a 322-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Sep 30, 2015
- Review
- 322 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972813 (1997). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972813 Gamma Locking Nail SystemHowmedica Corp. · 1997
- This deviceK143245 GPC Intramedullary Nailing SystemsGpc Medical Limited · 2015
- Descendant · cites it directly · 0 of its ownK253517 Reselute Tibial NailReselute, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK203811 GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited · 2022
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 |
|---|---|---|---|---|---|
| −1 | K972813 | Gamma Locking Nail System | Howmedica Corp. | 1997 | — |
| 0 (this device) | K143245 | GPC Intramedullary Nailing Systems | Gpc Medical Limited | 2015 | — |
| +1 | K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026 | — |
| +1 | K203811 | GPC Intraheal Intramedullary Nailing System | Gpc Medical Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (2)
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 6…PC Device Remarks (Predicate number Name Device 01 Tibial Nail Synthes (USA) K040762 GPC Multi System Ex Angle Tibial… | 2004 |
| * | K972813 | Gamma Locking Nail SystemSummary page 6…Ex Angle Tibial Nail 02 Gamma Nail Howmedica Inc. K972813 GPC Ga-mma The Nail Howmedica… | 1997 |
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?
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?
1. Indication for Use: Multi Angle Tibial Nail : The multi angle tibial nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions.
2. Indications for Use: Ga-mma Nails: The Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur.
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/K143245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143245: GPC Intramedullary Nailing Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143245
Report an extraction error
Are you the manufacturer?
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