510(k) · Cleared
ClearedHammerdesis™ Interphalangeal Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelivation · HTY Pin, Fixation, Smooth
Cleared on Sep 14, 2023 as substantially equivalent to K190287 (Arthrex, Inc., 2019) and 3 other predicates after a 146-day review. Its family tree reaches back 19 generations to 1984.
- Decided
- Sep 14, 2023
- Review
- 146 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 319 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 2 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- This deviceK231147 Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 6 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 5 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 4 generations backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- 3 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 2 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- This deviceK231147 Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −6 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −5 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| −3 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| −2 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| −1 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| 0 (this device) | K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 3 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 11 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 5 | 0 |
| 2001 | 12 | 0 |
| 2002 | 15 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 15 | 0 |
| 2006 | 13 | 0 |
| 2007 | 16 | 0 |
| 2008 | 28 | 0 |
| 2009 | 20 | 0 |
| 2010 | 13 | 0 |
| 2011 | 15 | 0 |
| 2012 | 13 | 0 |
| 2013 | 14 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 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 |
|---|---|---|---|
| * | K190287 | Arthrex DynaNite® PIP (Hammertoe) ImplantSummary page 5…K231147 III. Predicate Device Primary Predicate: 510(k) Number: K190287 Trade/proprietary name of device: Arthrex DynaNite PIP (Hammertoe) Implant Applicant: Arthrex Inc.… | 2019 |
| * | K131459 | Aap K-Wire, Steinmann Pin, Cerclage WireSummary page 5…fastener Classification: Class II Product Code: HTY Reference Device: 510(k) Number: K131459 Trade/proprietary name of device: AAP K-Wire, Steinmann Pin, Cerclage Wire Applicant: AAP Implantate… | 2013 |
| * | K191243 | HEDRON Cervical SpacersSummary page 5…fastener Classification: Class II Product Code: JDW (subsequent code: HTY) 510(k) Number: K191243 Trade/proprietary name of device: HEDRON Cervical Spacers Applicant: Globus Medical Inc. Regulation… | 2019 |
| * | K192417 | ARIX Cannulated Screw SystemSummary page 5….3080 Intervertebral body fusion device Classification: Class II Product Code: ODP, OVE 510(k) Number: K192417 Trade/proprietary name of device: ARIX Cannulated Screw System Applicant: Jeil Medical Corporation… | 2019 |
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 39 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 34 of the 319 ancestors have a recall of any class.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231147: Hammerdesis™ Interphalangeal Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231147
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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