510(k) · Cleared
ClearedSIGN IM Nail
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 Jul 20, 2017 as substantially equivalent to K051590 (Howmedica Osteonics Corp., 2005) and 3 other predicates after a 212-day review. Its family tree reaches back 13 generations to 1984.
- Decided
- Jul 20, 2017
- Review
- 212 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 94 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- 2 generations backK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- 1 generation backK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- This deviceK163589 SIGN IM NailSign Fracture Care International · 2017
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 6 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 5 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 4 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 3 generations backK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- 2 generations backK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- 1 generation backK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- This deviceK163589 SIGN IM NailSign Fracture Care International · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −6 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −5 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −4 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −3 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| −2 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| −1 | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| 0 (this device) | K163589 | SIGN IM Nail | Sign Fracture Care International | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K051590 | T2 Ankle Arthrodesis NailSummary page 4…Predicate Device: The SIGN IM Nail System is similar in design, function, and use to the following fixation devices. Stryker T2 Ankle Arthrodesis Nail System (K051590) - Primary Predicate SIGN IM Nail System (K022632) Small Bone Innovations A3 Interlocking Nail System (K112982)… | 2005 |
| * | K022632 | Sign IM NailSummary page 4…sign, function, and use to the following fixation devices. Stryker T2 Ankle Arthrodesis Nail System (K051590) - Primary Predicate SIGN IM Nail System (K022632) Small Bone Innovations A3 Interlocking Nail System (K112982) Carbofix Piccolo Composite Nailing System (K12381… | 2002 |
| * | K112982 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Summary page 4…tryker T2 Ankle Arthrodesis Nail System (K051590) - Primary Predicate SIGN IM Nail System (K022632) Small Bone Innovations A3 Interlocking Nail System (K112982) Carbofix Piccolo Composite Nailing System (K123810) Device Description The SIGN IM Nail System consists of multiple co… | 2012 |
| * | K123810 | Piccolo Composite Ankle Arthrodesis Nailing SystemSummary page 4…redicate SIGN IM Nail System (K022632) Small Bone Innovations A3 Interlocking Nail System (K112982) Carbofix Piccolo Composite Nailing System (K123810) Device Description The SIGN IM Nail System consists of multiple components; Standard IM Nail, Interlocking Screws, and a set of… | 2013 |
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 33 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 28 of the 94 ancestors have a recall of any class.
- 9 other devices also cite its predicate K051590.
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 SIGN IM Nail System is indicated for tibiotalocalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrosis, failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe arthritis, severe defects after tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.
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/K163589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163589: SIGN IM Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163589
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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