510(k) · Cleared
ClearedSIGN Hip Construct (SHC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sign Fracture Care International · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 13, 2015 as substantially equivalent to K083582 (Surgical Implant Generation Network (Sign), 2009) and 2 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Nov 13, 2015
- Review
- 50 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K972108 (1997). 12 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972108 | Alta Intramedullary Rod System | Howmedica Corp. | 1997 | — |
| −1 | K022632 | Sign IM Nail | Surgical Implant Generation Network (Sign) | 2002 | — |
| 0 (this device) | K152757 | SIGN Hip Construct (SHC) | Sign Fracture Care International | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K083582 | Sign Hip Construct (SHC), Model: 701Summary page 4…HSB, KTT, HRS Predicate Device: The SIGN Hip Construct (SHC) is similar in design, function, and use to the following fixation devices. SIGN Hip Construct (SHC) (K083582) - Primary Predicate SIGN IM Nail (K022632) Synthes 6.5mm Cannulated Screw (K021932) Device Description The SHC is an internal f… | 2009 |
| * | K022632 | Sign IM NailSummary page 4…SIGN Hip Construct (SHC) is similar in design, function, and use to the following fixation devices. SIGN Hip Construct (SHC) (K083582) - Primary Predicate SIGN IM Nail (K022632) Synthes 6.5mm Cannulated Screw (K021932) Device Description The SHC is an internal fixation device consisting of multiple compo… | 2002 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…sign, function, and use to the following fixation devices. SIGN Hip Construct (SHC) (K083582) - Primary Predicate SIGN IM Nail (K022632) Synthes 6.5mm Cannulated Screw (K021932) Device Description The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (I… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K083582.
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?
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.
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/K152757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152757: SIGN Hip Construct (SHC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152757
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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