510(k) · Cleared
ClearedMetasurg Digifuse Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metasurg · HWC Screw, Fixation, Bone
Cleared on Jul 21, 2011 as substantially equivalent to K062863 (Osteomed LP, 2006) and 2 other predicates after a 49-day review. Its family tree reaches back 3 generations to 2002. 30 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 49 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K013888 (2002). 10 ancestors in all, the oldest K954330 (1995). 30 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 2 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 1 generation backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- This deviceK111536 Metasurg Digifuse ImplantMetasurg · 2011
- Descendant · cites it directly · 22 of its ownK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 20 of its ownK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- Descendant · 3 generations on · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- Descendant · 3 generations on · 6 of its ownK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
- Descendant · 3 generations on · 4 of its ownK151838 PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K122959Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · cites it directly22descendants
- K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014 · 2 generations on20descendants
- K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014 · 3 generations on9descendants
- K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015 · 3 generations on6descendants
- K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −2 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −1 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| 0 (this device) | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| +1 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| +2 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| +3 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| +3 | K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015 | — |
| +3 | K151838 | PRO-TOE Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw SystemSummary page 1…CFR 888.3040, Product Code HWC, Class 11) Comoino Name: Intrarnedullary Bone Fastener Predicate Devices: OsteoMed Ext. 2.0/2.4 CannUlated Screw System (K062863) Wright Medical Pro-Toe (1(101 165) NEWDEAL K-Wire (K022599) Device Description:… | 2006 |
| * | K101165 | Pro-Toe VO Hammertow Implant System | 2010 |
| * | K022599 | Newdeal K WireSummary page 1…ate Devices: OsteoMed Ext. 2.0/2.4 CannUlated Screw System (K062863) Wright Medical Pro-Toe (1(101 165) NEWDEAL K-Wire (K022599) Device Description: The Metasurg DigiFuse Implant is a one-piece threaded device made of titanium int… | 2002 |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122959 | Hammer Toe Implant | 2012 | 22 |
| K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | 2014 | 2 |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System | 2015 | 1 |
| K141937 | Trident Fusion Implant | 2014 | 1 |
| K150211 | EzFuze Implant System | 2015 | 0 |
| K140283 | Osteomed Extremifuse System | 2014 | 0 |
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 9 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K122959 (Trilliant Surgical, Ltd., 2012) has gone furthest, with 22 descendants of its own.
- 7 other devices also cite its predicate K062863.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
* Hammer toe deformity
* Claw toe deformity
* Mallet toe deformity
* Other deformities of the feet and hands
The Metasurg DigiFuse implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111536: Metasurg Digifuse Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111536
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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