510(k) Report

510(k) · Cleared

Cleared

Sign Hip Construct (SHC), Model: 701

K083582510(k) TraditionalCleared Aug 26, 2009265-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Surgical Implant Generation Network (Sign) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Aug 26, 2009 as substantially equivalent to K043200 (Surgical Implant Generation Network (Sign), 2005) and 5 other predicates after a 265-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.

Decided
Aug 26, 2009
Review
265 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K983641 (1998). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 3 other ancestors2003: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant clearedK983641 · Holland Femoral Nail System · Biomet, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants K983641 · Holland Femoral Nail System · Biomet, Inc. · 19980
  1. Root · 1 generation backK983641 Holland Femoral Nail SystemBiomet, Inc. · 1998
  2. This deviceK083582 Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009
  3. Descendant · cites it directly · 0 of its ownK153759 SIGN Compression Screw SystemSign Fracture Care International · 2016
  4. Descendant · cites it directly · 0 of its ownK152757 SIGN Hip Construct (SHC)Sign Fracture Care International · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K153759SIGN Compression Screw SystemSign Fracture Care International · 2016 · cites it directly0descendants
  • K152757SIGN Hip Construct (SHC)Sign Fracture Care International · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983641Holland Femoral Nail SystemBiomet, Inc.1998—
0 (this device)K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign)2009—
+1K153759SIGN Compression Screw SystemSign Fracture Care International2016—
+1K152757SIGN Hip Construct (SHC)Sign Fracture Care International2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200530
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
FIG. 1 — Lineage of K083582, 1998–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043200Sign Fin Nail
Summary page 1
…KTT, HSB, HRS signcom(?sign-post.org Substantial Equivalence Information The SIGN Hip Construct (SHC) is similar to the following predicate devices: , SIGN Fin Nail (K043200) Holland Femoral Nail System (K983641) Synthes Locking Stabilization Plate (K052677) , Howmedica Omega 3 Trochan…
Surgical Implant Generation Network (Sign)2005—
*K983641Holland Femoral Nail System
Summary page 1
…tial Equivalence Information The SIGN Hip Construct (SHC) is similar to the following predicate devices: , SIGN Fin Nail (K043200) Holland Femoral Nail System (K983641) Synthes Locking Stabilization Plate (K052677) , Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) Ho…
Biomet, Inc.1998—
*K052677Synthes Universal Locking Trochanter Stabilization Plate (Ultsp)
Summary page 1
…SHC) is similar to the following predicate devices: , SIGN Fin Nail (K043200) Holland Femoral Nail System (K983641) Synthes Locking Stabilization Plate (K052677) , Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) Howmedica T2 Recon Nail (K051624) , Synthes CerviFix…
Synthes (Usa)2005—
*K081278Omega 3 Trochanteric Stabilizing Plate
Summary page 1
…Nail (K043200) Holland Femoral Nail System (K983641) Synthes Locking Stabilization Plate (K052677) , Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) Howmedica T2 Recon Nail (K051624) , Synthes CerviFix (K030377) All of the devices listed above are similar in both th…
Howmedica Osteonics Corp.2008—
*K051624T2 Recon Nail System
Summary page 1
…l System (K983641) Synthes Locking Stabilization Plate (K052677) , Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) Howmedica T2 Recon Nail (K051624) , Synthes CerviFix (K030377) All of the devices listed above are similar in both their intended use and the basic concept by…
Howmedica Osteonics Corp.2005—
*K030377Modification to Synthes Cervifix System
Summary page 1
…s Locking Stabilization Plate (K052677) , Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) Howmedica T2 Recon Nail (K051624) , Synthes CerviFix (K030377) All of the devices listed above are similar in both their intended use and the basic concept by which they are used. The safety…
Synthes (Usa)2003—

Also cleared against K043200: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153759SIGN Compression Screw SystemSign Fracture Care International20160
K152757SIGN Hip Construct (SHC)Sign Fracture Care International20150

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K153759 (Sign Fracture Care International, 2016) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K043200.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.

Indications for use as stated in the FDA summary.

Also cleared against K043200

1 other device cites the same predicate.

  • K122823Sign Pediatric Fin NailSign Fracture Care International · 2013

More from Surgical Implant Generation Network…

4 FDA decisions under this applicant name. See the company

  • K043200Sign Fin NailSurgical Implant Generation Network (Sign) · 2005
  • K022632Sign IM NailSurgical Implant Generation Network (Sign) · 2002
  • K013132Sign IM NailSurgical Implant Generation Network (Sign) · 2001

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K083582 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083582: Sign Hip Construct (SHC), Model: 701.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083582

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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