510(k) · Cleared
ClearedMetatarsophalangeal Flexible Stabilizing Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Nov 25, 2002 as substantially equivalent to K884739 (Sgarlato Laboratories, Inc., 1989) after an 87-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Nov 25, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884739 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884739 Sgarlato Lesser Toe ImplantSgarlato Laboratories, Inc. · 1989
- This deviceK022886 Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
- Descendant · cites it directly · 1 of its ownK173491 RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
- Descendant · cites it directly · 0 of its ownK102601 Orthoflex RodOrtho-Pro, LLC · 2011
Most influential descendants
Showing 3 of 3 · See all- K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018 · cites it directly1descendant
- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · 2 generations on0descendants
- K102601Orthoflex RodOrtho-Pro, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884739 | Sgarlato Lesser Toe Implant | Sgarlato Laboratories, Inc. | 1989 | — |
| 0 (this device) | K022886 | Metatarsophalangeal Flexible Stabilizing Rod System | Osteomed Corp. | 2002 | — |
| +1 | K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018 | — |
| +2 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
| +1 | K102601 | Orthoflex Rod | Ortho-Pro, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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? (1)
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 |
|---|---|---|---|
| * | K884739 | Sgarlato Lesser Toe ImplantSummary page 1…Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Lesser Toe Implant (K884739) by Futura Biomedical. Due to the similarity of materials and design to both pre-enactment and post-… | 1989 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K173491 (In2bones USA, LLC, 2018) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022886: Metatarsophalangeal Flexible Stabilizing Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022886
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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