510(k) · Cleared
ClearedSgarlato Lesser Toe Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgarlato Laboratories, Inc. · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on May 18, 1989 after a 185-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 18, 1989
- Review
- 185 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK884739 Sgarlato Lesser Toe ImplantSgarlato Laboratories, Inc. · 1989
- Descendant · cites it directly · 3 of its ownK022886 Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
- Descendant · 2 generations on · 1 of its ownK173491 RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK102601 Orthoflex RodOrtho-Pro, LLC · 2011
Most influential descendants
Showing 4 of 4 · See all- K022886Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002 · cites it directly3descendants
- K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018 · 2 generations on1descendant
- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · 3 generations on0descendants
- K102601Orthoflex RodOrtho-Pro, LLC · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884739 | Sgarlato Lesser Toe Implant | Sgarlato Laboratories, Inc. | 1989 | — |
| +1 | K022886 | Metatarsophalangeal Flexible Stabilizing Rod System | Osteomed Corp. | 2002 | — |
| +2 | K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018 | — |
| +3 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
| +2 | K102601 | Orthoflex Rod | Ortho-Pro, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWH? 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 KWH device
- #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022886 | Metatarsophalangeal Flexible Stabilizing Rod System | 2002 | 3 |
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?
- Of its descendants, K022886 (Osteomed Corp., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KWH
Too few KWH 510(k)s in any year since 2007 to give a median.
Recalls per year · KWH
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWH
8in 2025
MAUDE reports naming product code KWH, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K884739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884739: Sgarlato Lesser Toe Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884739
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026