510(k) · Cleared
ClearedThe Hammertoe Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · HWC Screw, Fixation, Bone
Cleared on Aug 1, 2016 as substantially equivalent to K050259 (Arthrex, Inc., 2005) and 1 other predicate after a 284-day review. Its family tree reaches back 7 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 1, 2016
- Review
- 284 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K915818 (1992). 32 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 6 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 5 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 4 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 3 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- 2 generations backK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
- 1 generation backK150126 Life Spine Cannulated ScrewsLife Spine, Inc. · 2015
- This deviceK153065 The Hammertoe Correction SystemLife Spine, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK171448 Hammertoe Correction SystemLife Spine, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK162685 2-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017
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 |
|---|---|---|---|---|---|
| −7 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −6 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −5 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −4 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −3 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| −2 | K092670 | Biodrive Micro Screw System | Ebi,Llc D/B/A Biomet Trauma | 2009 | — |
| −1 | K150126 | Life Spine Cannulated Screws | Life Spine, Inc. | 2015 | — |
| 0 (this device) | K153065 | The Hammertoe Correction System | Life Spine, Inc. | 2016 | — |
| +1 | K171448 | Hammertoe Correction System | Life Spine, Inc. | 2017 | — |
| +1 | K162685 | 2-Piece Hammertoe Correction System | Life Spine, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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? (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 |
|---|---|---|---|
| * | K050259 | Arthrex Bio-PinSummary page 4…on Name: Smooth or Threaded Metallic Bone Fixation Fastener Classification: HWC, CFR 888.3040, Class II Primary Predicate: Arthrex BioPin (K050259) Life Spine Cannulated Screws (K150126) Device Description: The Hammertoe Correction System is an… | 2005 |
| * | K150126 | Life Spine Cannulated ScrewsSummary page 4…ner Classification: HWC, CFR 888.3040, Class II Primary Predicate: Arthrex BioPin (K050259) Life Spine Cannulated Screws (K150126) Device Description: The Hammertoe Correction System is an implant with dual threaded design and is inserted between the pro… | 2015 |
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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 32 ancestors have a recall of any class.
- Of its descendants, K171448 (Life Spine, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K050259.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153065: The Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153065
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